Colitis, Ulcerative
Icotrokinra for Adults and Adolescents With Active Ulcerative Colitis
This phase 3 study is evaluating the efficacy, safety, and tolerability of oral icotrokinra in adults and adolescents with moderately to severely active ulcerative colitis.
Registry title: A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
50 recruiting U.S. sites ↓Study at a glance
- Age
- 12 Years and older
- Treatment
- Icotrokinra or Placebo
- Design
- Randomized · Double
- Central study contact
- Study Contact844-434-4210Participate-In-This-Study1@its.jnj.com
- Sponsor
- Janssen Research & Development, LLC
Research question
How effective, safe, and tolerable is oral icotrokinra as induction and maintenance therapy for adults and adolescents with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults and adolescents age 12 years or older.
- The study is looking for people with ulcerative colitis diagnosed at least 12 weeks before screening and supported by endoscopy and a pathology report.
- The study is looking for people whose ulcerative colitis is moderately to severely active according to specified Mayo and endoscopy scores.
- The study is looking for people who did not respond adequately to or could not tolerate specified conventional or advanced ulcerative colitis therapies.
- Adolescent participants must weigh at least 40 kilograms at the start of induction treatment.
Participation overview
What participation may involve
Participants take a study tablet by mouth each day, complete a 12-week induction phase, are assessed for clinical response, and enter a maintenance phase through Week 40. Eligible participants may then enter a long-term extension. What participation may involve: - Take icotrokinra or, for adults assigned to a placebo group, a placebo tablet by mouth each day. - Undergo an assessment of clinical response at induction Week 12 before entering maintenance. - Complete assessments of symptoms, clinical remission or response, endoscopic findings, tissue inflammation, quality of life, fatigue, and adverse events, as applicable. - Participants who complete maintenance through Week 40 may be able to enter a long-term extension if the study's additional requirements are met. The reported core study includes induction through Week 12 followed by maintenance through Week 40. A long-term extension is mentioned, but its duration is not reported.
Study interventions
What participants may receive or do
- Icotrokinra: Icotrokinra is given by mouth as a tablet. The registry states that participants assigned to it take it daily during the applicable induction and maintenance phases.
- Placebo: The placebo is an oral tablet used as a comparison in the randomized adult induction and maintenance study; adolescents are not described as receiving placebo.
Study design
How the comparison works
This phase 3 study uses different designs by age: adults enter randomized, parallel, double-blind, placebo-controlled induction and maintenance groups, while adolescents receive icotrokinra in open-label induction and maintenance phases. Adults are randomly assigned during induction and, for some response groups, again during maintenance. The registry does not describe adolescents as randomized. Adult participants and investigators are masked to adult treatment assignments. The adolescent phases are open-label, so their assigned treatment is known. Placebo tablets serve as the control in the adult induction and maintenance study. The adolescent phases have no placebo control described. Adults may receive oral placebo during induction or maintenance depending on randomization and their induction response. The assignment ratio and individual placebo probability are not reported.
Reported activities
Procedures and tests
- Screening includes confirmation that ulcerative colitis was diagnosed at least 12 weeks earlier using endoscopic evidence and a consistent histopathology report.
- A screening video endoscopy is centrally reviewed to determine the endoscopy subscore and help establish baseline disease activity.
- Disease activity is assessed with the modified Mayo score, including stool frequency, rectal bleeding, and endoscopy findings.
- Endoscopic and histologic assessments are used to evaluate improvement or remission of the bowel lining.
- Adults complete the 32-item Inflammatory Bowel Disease Questionnaire about bowel and general symptoms, social function, and emotional function.
- Adults complete a seven-item fatigue questionnaire about tiredness, energy, and effects on daily activities.
- Adults report ulcerative colitis symptoms such as bowel urgency, abdominal pain, and bowel incontinence using a nine-item questionnaire with a 24-hour recall period.
- Adolescents are assessed with the Pediatric Ulcerative Colitis Activity Index, which covers abdominal pain, rectal bleeding, stool features, nighttime bowel movements, and activity level.
- Adverse events and serious adverse events are monitored during induction and maintenance.
- Participants subject to the pregnancy criteria have serum pregnancy testing at screening, urine testing before the first study dose, and additional pregnancy tests.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Ulcerative colitis must have been diagnosed at least 12 weeks before screening, with both endoscopic evidence and a consistent histopathology report.
- At induction baseline, the modified Mayo score must be from 5 through 9 using the centrally reviewed screening endoscopy score.
- The centrally reviewed screening video endoscopy must produce an endoscopy subscore of at least 2.
- Adolescent participants must weigh at least 40 kilograms at induction baseline.
- Adult females who can become pregnant and all adolescent females must meet the specified serum and urine pregnancy-testing requirements and agree to further testing.
- Participants must have had an inadequate response to or intolerance of conventional therapy while advanced-therapy naïve, or an inadequate response to or intolerance of biologic or advanced oral therapy, as defined by the protocol.
Possible reasons someone may not be able to join
- People with current ulcerative colitis complications such as fulminant colitis, toxic megacolon, or another manifestation that might require colon surgery during the study are excluded.
- People with a stoma are excluded.
- People with a current or previous fistula are excluded.
- People are excluded if they had colon resection within 24 weeks before baseline or other intra-abdominal or major surgery within 12 weeks before baseline.
- People are excluded if less than 30 centimeters of colon remains or a prior resection could interfere with disease-severity assessments such as the Mayo score.
Important unknowns
What the record does not make clear
- The registry names several assessment weeks but does not provide the number, frequency, length, or format of study visits.
- Induction through Week 12 and maintenance through Week 40 are described, but the screening period, follow-up period, and long-term extension duration are not reported.
- Adults may be randomized to placebo, but the assignment ratios for induction and maintenance are not stated.
- The registry does not state which current ulcerative colitis medicines may continue during the study.
- Required medication washout periods are not provided in the registry record.
- The registry does not explain what treatment is available if ulcerative colitis worsens or does not respond.
- A centrally reviewed screening video endoscopy is required, and endoscopic outcomes are measured, but the number and timing of later endoscopies are not specified.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation or reimbursement is not described.
- Travel and lodging support are not described.
- The registry does not say whether any visits or assessments can be completed remotely.
- Eligible participants may enter a long-term extension after maintenance, but its eligibility rules, duration, treatment assignments, and access after the extension are not reported.
- The study is listed as recruiting and many individual locations are listed as recruiting, but the registry does not confirm that every age group or treatment-history cohort is open at each location.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including screening, induction, maintenance, follow-up, and the long-term extension?
- For adults, what are the assignment ratios and chances of receiving placebo during induction and maintenance?
- Which current ulcerative colitis medicines may continue, and are any washout periods required?
- What happens if symptoms worsen or clinical response is not achieved, and what rescue treatment is allowed?
- How many endoscopies and biopsies are required, and what preparation, sedation, and recovery time should be expected?
- Which study-related expenses are covered, and are compensation, transportation, or lodging assistance available?
- Is my nearest site enrolling adults, adolescents, or both, and is the relevant treatment-history cohort open?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and what are the risks of changing my current treatment to meet this study's requirements?
- Which approved treatment alternatives are reasonable for me compared with considering this study?
- Do my prior medicines and responses appear to match the protocol's conventional-therapy or advanced-therapy history categories?
- Are repeated endoscopies, biopsies, placebo exposure, or a delay before active treatment especially concerning in my clinical situation?
- How should my gastroenterology team and the research team coordinate routine care, flare management, test results, and urgent concerns?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- 77242113UCO3001
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child, Adult, Older Adult
Study arms
Experimental
Double-blind (DB) Induction Study: Icotrokinra
Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Interventions: Drug: Icotrokinra
Placebo Comparator
DB Induction Study: Placebo
Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Interventions: Drug: Placebo
Experimental
DB Maintenance Study: Icotrokinra
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
Interventions: Drug: Icotrokinra
Placebo Comparator
DB Maintenance Study: Placebo
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
Interventions: Drug: Placebo
Experimental
Open-label (OL) Induction Phase: Icotrokinra
Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
Interventions: Drug: Icotrokinra
Experimental
OL Maintenance Phase: Icotrokinra
Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
Interventions: Drug: Icotrokinra
Interventions
Drug
Icotrokinra
Icotrokinra tablet will be administered orally.
Drug
Placebo
Placebo tablet will be administered orally.
Eligibility
12 Years and older
All
Not accepted
Inclusion criteria (6)
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UCRegistry-derived · unreviewed
- Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopyRegistry-derived · unreviewed
- An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopyRegistry-derived · unreviewed
- Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)Registry-derived · unreviewed
- Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy testsRegistry-derived · unreviewed
- Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocolRegistry-derived · unreviewed
Exclusion criteria (5)
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the studyRegistry-derived · unreviewed
- Presence of a stomaRegistry-derived · unreviewed
- Presence or history of a fistulaRegistry-derived · unreviewed
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baselineRegistry-derived · unreviewed
- History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study interventionRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
Time frame: At Week I-12
Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Primary outcome
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Primary outcome
Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12
Time frame: At Week I-12
Percentage of adult participants in clinical response at Week I-12 will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12
Time frame: At Week I-12
Percentage of adult participants with endoscopic improvement at Week I-12 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12
Time frame: At Week I-12
Percentage of adult participants in symptomatic remission at Week I-12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
Time frame: At Week I-12
Percentage of adult participants with IBDQ remission at Week I-12 will be reported. IBDQ remission is defined as an IBDQ total score of \>= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12
Time frame: At Week I-12
Percentage of adult participants with HEMI at Week I-12 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12
Time frame: At Week I-12
Percentage of adult participants with fatigue response at Week I-12 will be reported. Fatigue response is defined as a \>= 7-point reduction in the patient-reported outcomes measurement information system (PROMIS)-fatigue Short Form (SF)-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).
Secondary outcome
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4
Time frame: At Week I-4
Percentage of adult participants in symptomatic remission at Week I-4 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Secondary outcome
DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12
Time frame: At Week I-12
Percentage of adult participants in endoscopic remission at Week I-12 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12
Time frame: At Week I-12
Percentage of adult participants with no bowel urgency at Week I-12 will be reported using the ulcerative colitis patient-reported outcomes signs and symptoms (UC-PRO/SS). The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of gastrointestinal (GI) signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12
Time frame: At Week I-12
Percentage of adult participants with no abdominal pain at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12
Time frame: At Week I-12
Percentage of adult participants with no bowel incontinence at Week I-12 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week I-12
Percentage of adult participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, is medically important.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with Endoscopic Improvement at Week M-40
Time frame: At Week M-40
Percentage of adult participants with endoscopic improvement at Week M-40 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants in Symptomatic Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants in symptomatic remission at Week M-40 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with 90-day Corticosteroid-free Clinical Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants with 90-day corticosteroid-free clinical remission at Week M-40 will be reported. 90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with HEMI at Week M-40
Time frame: At Week M-40
Percentage of adult participants with HEMI at Week M-40 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in \< 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with IBDQ Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants with IBDQ remission at Week M-40 will be reported. IBDQ remission is defined as an IBDQ total score of \>= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants in Endoscopic Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants in endoscopic remission at Week M-40 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline
Time frame: At Week M-40
Percentage of adult participants in clinical remission at Week M-40 among the participants who had achieved clinical remission at maintenance baseline will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants in Histologic-Endoscopic Mucosal Remission at Week M-40
Time frame: At Week M-40
Percentage of adult participants in histologic-endoscopic mucosal remission at Week M-40 will be reported. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission. Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with Fatigue Response at Week M-40
Time frame: At Week M-40
Percentage of adult participants with fatigue response at Week M-40 will be reported. Fatigue response is defined as a \>= 7-point reduction in the PROMIS-fatigue SF-7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with Disease Clearance at Week M-40
Time frame: At Week M-40
Percentage of adult participants with disease clearance at Week M-40 will be reported. Disease clearance is defined as a composite of symptomatic remission and histologic-endoscopic mucosal remission. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with No Bowel Urgency at Week M-40
Time frame: At Week M-40
Percentage of adult participants with no bowel urgency at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with No Abdominal Pain at Week M-40
Time frame: At Week M-40
Percentage of adult participants with no abdominal pain at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with No Bowel Incontinence at Week M-40
Time frame: At Week M-40
Percentage of adult participants with no bowel incontinence at Week M-40 will be reported using the UC-PRO/SS. The UC-PRO/SS is a 9-item measure that was developed to standardize the quantification of GI signs and symptoms of UC through direct report from participant ratings. The module includes both bowel signs and symptoms and abdominal symptoms, with a recall period of 24 hours.
Secondary outcome
DB Maintenance Study: Percentage of Adult Participants with AEs and SAEs
Time frame: Up to Week M-40
Percentage of adult participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants in Clinical Response at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants in clinical response at Week I-12 will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants in Clinical Remission at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants with HEMI at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants with HEMI at Week I-12 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (\<) 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants with Endoscopic Improvement at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants with endoscopic improvement at Week I-12 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants in symptomatic remission at Week I-12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants in Endoscopic Remission at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants in endoscopic remission at Week I-12 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants in Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week I-12
Time frame: At Week I-12
Percentage of adolescent participants in PUCAI remission at Week I-12 will be reported. PUCAI remission is defined as a PUCAI score \<10. The PUCAI is a non-invasive instrument for measuring disease activity in adolescents with UC. Disease activity is determined as a score based on evaluation of abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score ranges from 0 to 85.
Secondary outcome
OL Induction Phase: Percentage of Adolescent Participants with AEs and SAEs
Time frame: Up to Week I-12
Percentage of adolescent participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Secondary outcome
OL Maintenance Study: Percentage of Adolescent Participants with Endoscopic Improvement at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants with endoscopic improvement at Week M-40 will be reported. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants in Symptomatic Remission at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants in symptomatic remission at Week M-40 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants in 90-day Corticosteroid-free Clinical Remission at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants in 90-day corticosteroid-free clinical remission at Week M-40 will be reported. 90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants with HEMI at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants with HEMI at Week M-40 will be reported. HEMI is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in \< 5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy sub-score of 0 or 1.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants with Histologic-Endoscopic Mucosal Remission at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants with histologic-endoscopic mucosal remission at Week M-40 will be reported. Histologic-endoscopic mucosal remission is defined as achieving a combination of histologic remission and endoscopic remission. Histologic remission is defined as the absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants with Endoscopic Remission at Week M-40
Time frame: At Week M-40
Percentage of adolescent participants with endoscopic remission at Week M-40 will be reported. Endoscopic remission is defined as an endoscopy subscore of 0.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 Among the Participants who had Achieved Clinical Remission at Maintenance Baseline
Time frame: At Week M-40
Percentage of adolescent participants in clinical remission at Week M-40 among the participants who had achieved clinical remission at maintenance baseline will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants in Clinical Response at Week M-40 Among the Participants who had Achieved Clinical Response at Maintenance Baseline
Time frame: At Week M-40
Percentage of adolescent participants in clinical response at Week M-40 among the participants who had achieved clinical response at maintenance baseline will be reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by \>= 30 % and \>=2 points, with either a \>=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants in PUCAI Remission at Week-40
Time frame: At Week M-40
Percentage of adolescent participants in PUCAI remission at Week M-40 will be reported. PUCAI remission is defined as a PUCAI score \<10. The PUCAI is a non-invasive instrument for measuring disease activity in adolescents with UC. Disease activity is determined as a score based on evaluation of abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score ranges from 0 to 85.
Secondary outcome
OL Maintenance Phase: Percentage of Adolescent Participants with AEs and SAEs
Time frame: Up to Week M-40
Percentage of adolescent participants with AEs and SAEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Recruiting locations in the United States
AZ Gastro Care
RecruitingChandler, Arizona, 85206, United States
Research Solutions of Arizona
RecruitingLitchfield Park, Arizona, 85340, United States
Mayo Clinic
RecruitingScottsdale, Arizona, 85259, United States
Clinnova Research
RecruitingAnaheim, California, 92805, United States
Southern California Research Center
RecruitingCoronado, California, 92118, United States
Om Research LLC
RecruitingLancaster, California, 93534, United States
GastroIntestinal Bioscience
RecruitingLos Angeles, California, 90067, United States
TLC Clinical Research Inc
RecruitingLos Angeles, California, 90048, United States
Hoag Memorial Hospital
RecruitingNewport Beach, California, 92658, United States
Om Research LLC 2
RecruitingOxnard, California, 93030, United States
Medical Associates Research Group, Inc.
RecruitingSan Diego, California, 92123, United States
University of California San Francisco
RecruitingSan Francisco, California, 94115, United States
Peak Gastroenterology Associates
RecruitingColorado Springs, Colorado, 80907, United States
Connecticut Children's Medical Center
RecruitingHartford, Connecticut, 06106, United States
American Institute of Research
RecruitingCutler Bay, Florida, 33157, United States
Nature Coast Clinical Research
RecruitingInverness, Florida, 34452, United States
Florida Research Institute
RecruitingLakewood Rch, Florida, 34211, United States
GCP Clinical Research
RecruitingTampa, Florida, 33609, United States
Atlanta Gastroenterology Associates
RecruitingAtlanta, Georgia, 30342, United States
Children's Center for Digestive Health Care
RecruitingAtlanta, Georgia, 30342, United States
Gastroenterolgy Associates of Central GA
RecruitingMacon, Georgia, 31201, United States
IU Health University Hospital
RecruitingIndianapolis, Indiana, 46202, United States
Cotton O'Neil Digestive Health Center
RecruitingTopeka, Kansas, 66606, United States
Tri-State Gastroenterology Assoc
RecruitingCrestview Hills, Kentucky, 41017, United States
Delta Research Partners, LLC
RecruitingWest Monroe, Louisiana, 71291, United States
Chevy Chase Clinical Research
RecruitingChevy Chase, Maryland, 20815, United States
Woodholme Gastroenterology Associates
RecruitingGlen Burnie, Maryland, 21061, United States
Westchester Putnam Gastroenterology
RecruitingCarmel, New York, 10512, United States
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
Inflammatory Bowel Disease Center at NYU Langone
RecruitingNew York, New York, 10016, United States
Lenox Hill Hospital
RecruitingNew York, New York, 10075, United States
New York Gastroenterology Associates
RecruitingNew York, New York, 10075, United States
Weill Cornell Medical College
RecruitingNew York, New York, 10065, United States
University of North Carolina
RecruitingChapel Hill, North Carolina, 27599, United States
Atrium Health
RecruitingCharlotte, North Carolina, 28204, United States
The Oregon Clinic
RecruitingPortland, Oregon, 97220-9428, United States
Susquehanna Research Group
RecruitingHarrisburg, Pennsylvania, 17110-3673, United States
Penn State Milton S Hershey Medical Ctr
RecruitingHershey, Pennsylvania, 17033, United States
Jefferson Digestive Health Institute
RecruitingPhiladelphia, Pennsylvania, 19107, United States
University of Pennsylvania
RecruitingPhiladelphia, Pennsylvania, 19104, United States
University Gastroenterology
RecruitingProvidence, Rhode Island, 02905, United States
The University of Texas at Austin
RecruitingAustin, Texas, 78712, United States
DFW Clinical Trials
RecruitingCarrollton, Texas, 75010, United States
Victorium Clinical Research
RecruitingHouston, Texas, 77024, United States
Southern Star Research Institute, LLC
RecruitingSan Antonio, Texas, 78229, United States
GI Alliance Southlake
RecruitingSouthlake, Texas, 76092, United States
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Gastroenterology Associates of Tidewater
RecruitingChesapeake, Virginia, 23320, United States
Blue Ridge Medical Research
RecruitingLynchburg, Virginia, 24502, United States
GI Alliance Tacoma
RecruitingTacoma, Washington, 98405, United States
This study also lists 345 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Sep 29, 2025
- Primary completion
- Jan 14, 2028
- Overall completion
- Jan 13, 2032
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.