Crohn Disease
Icotrokinra for Adults With Moderately to Severely Active Crohn’s Disease
This study is evaluating the effectiveness and safety of daily oral icotrokinra compared with placebo in adults with moderately to severely active Crohn’s disease.
Registry title: A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
54 recruiting U.S. sites ↓Study at a glance
- Age
- 18 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 and safe is icotrokinra for treating moderately to severely active Crohn’s disease compared with placebo during induction and maintenance treatment?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older.
- The study is looking for people whose Crohn’s disease was diagnosed at least 12 weeks before screening and supported by endoscopy and a pathology report.
- The study is looking for people with moderately to severely active Crohn’s disease based on symptom scores and centrally reviewed ileocolonoscopy findings.
- The study is looking for people who did not respond adequately to or could not tolerate specified conventional or advanced Crohn’s therapies.
Participation overview
What participation may involve
Participants receive daily oral icotrokinra or matching placebo during a 12-week induction study. Subsequent treatment is based on Week 12 response and may include icotrokinra, placebo, or a blinded icotrokinra dose adjustment during maintenance. What participation may involve: - Take icotrokinra or matching placebo by mouth each day. - Complete Crohn’s disease symptom assessments, including abdominal-pain and stool-frequency reporting. - Undergo endoscopic assessments used to measure Crohn’s disease activity and response. - Complete quality-of-life and fatigue questionnaires and be monitored for adverse events. The registry describes induction treatment through Week 12 and maintenance treatment through Week 40. Eligible participants may then enter a long-term extension, but the individual’s total participation duration is not stated.
Study interventions
What participants may receive or do
- Icotrokinra: Icotrokinra, also called JNJ-77242113, is the study drug and is taken by mouth once daily. The record describes multiple induction and maintenance dose groups but does not provide dose amounts.
- Placebo: The matching placebo is taken by mouth once daily and is used as a comparison during induction and maintenance portions of the study.
Study design
How the comparison works
This is a Phase 2/Phase 3, multicenter treatment study with parallel groups. It includes induction studies through Week 12, followed by response-dependent maintenance treatment through Week 40 and an optional long-term extension for eligible participants. The study uses random assignment. Initial induction groups and some maintenance groups are randomized, while the record states that certain maintenance assignments depend on Week 12 response and are not randomized. Participants and investigators are masked to assigned treatment. The record also describes blinded dose adjustments for some participants who lose response during maintenance. Matching placebo groups provide the comparison for icotrokinra during induction and maintenance. Some participants receive daily oral matching placebo. Treatment after Week 12 depends on induction treatment and response, so the record does not establish one placebo probability that applies to everyone.
Reported activities
Procedures and tests
- Screening includes confirmation that the Crohn’s disease diagnosis is supported by endoscopic evidence and a histopathology report.
- A screening video ileocolonoscopy is centrally reviewed to score active ileal or colonic disease using the Simple Endoscopic Score for Crohn’s Disease.
- Crohn’s Disease Activity Index assessments measure symptoms and disease activity, including at Weeks 4, 12, and 40 for specified outcomes.
- Endoscopic response and remission are assessed using the Simple Endoscopic Score for Crohn’s Disease at Weeks 12 and 40.
- Participants report abdominal pain and stool frequency for patient-reported outcome assessments.
- Participants complete the 32-item Inflammatory Bowel Disease Questionnaire about bowel and systemic symptoms, social function, and emotional function.
- Participants complete the seven-item PROMIS Fatigue Short Form about fatigue symptoms and effects on daily activities.
- Tissue histology is evaluated for specified remission outcomes using the Robarts Histopathology Index.
- Adverse events and serious adverse events are monitored through four weeks after the last study-drug dose in the induction and maintenance studies.
- Participants who could become pregnant have a serum pregnancy test at screening, a urine pregnancy test before study intervention at Week I-0, and further pregnancy testing.
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
- Crohn’s disease must have been diagnosed at least 12 weeks before screening, with both endoscopic evidence and a pathology report supporting the diagnosis.
- At baseline, the Crohn’s Disease Activity Index must be 220 to 450, with either an average daily stool frequency of at least 4 or an average daily abdominal-pain score of at least 2.
- Central review of the screening video ileocolonoscopy must show ulceration and a Simple Endoscopic Score for Crohn’s Disease of at least 6 for colonic or ileocolonic disease, or at least 4 for isolated ileal disease.
- Participants must have had an inadequate response to or been unable to tolerate specified conventional therapy while being advanced-therapy naïve, or have had an inadequate response to or intolerance of biologic or advanced oral therapy, as defined in the protocol.
- A participant who could become pregnant must have negative serum and urine pregnancy tests at the specified times and agree to further testing.
- Participants must be at least 18 years old.
Possible reasons someone may not be able to join
- Crohn’s complications such as symptomatic strictures, stenoses, or short gut syndrome exclude participation when they may require surgery during the study or interfere with assessment of treatment response.
- People with a stoma or ostomy are excluded.
- An active fistula does not automatically exclude someone if it does not require surgery; the study team must confirm how this exception applies.
- A colonic resection within 24 weeks before baseline or another major operation within 12 weeks before baseline excludes participation.
- Adenomatous colon polyps found outside an area of known colitis during screening colonoscopy must be removed before randomization.
Important unknowns
What the record does not make clear
- The registry reports assessment weeks but does not provide the number, timing, length, or format of study visits.
- Induction continues through Week 12 and maintenance through Week 40, with an optional long-term extension for eligible participants, but total individual participation time is not stated.
- The study includes placebo groups and response-dependent maintenance assignments, but the chance of receiving placebo in each stage is not reported.
- The registry does not clearly state which current Crohn’s treatments may continue during the study.
- Required waiting periods after previous conventional, biologic, or advanced oral therapies are not provided.
- The record describes response-dependent treatment and blinded dose adjustments but does not fully explain other rescue-treatment options if symptoms worsen.
- A screening video ileocolonoscopy and endoscopic outcomes at Weeks 12 and 40 are described, but the complete endoscopy schedule and whether all participants undergo each procedure are not explicit.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation or reimbursement is not described.
- The registry does not describe transportation, lodging, or other travel support.
- The record does not state whether any visits or assessments can occur remotely or through a local clinician.
- Eligible participants may enter a long-term extension, but access to icotrokinra after the extension or after study participation ends is not described.
- The overall study is recruiting, but this does not confirm that a particular site, induction study, or cohort has an available opening.
Before contacting the site
Questions for the study team
- Which induction study would I enter, what are its assignment ratios, and what is the chance of placebo?
- How will my Week 12 response determine maintenance treatment, and could I later receive a blinded dose adjustment?
- What is the complete visit schedule, including the required ileocolonoscopies, biopsies, laboratory tests, and questionnaires?
- Which current Crohn’s medicines can continue, and are any washout periods required before treatment starts?
- What happens if my disease worsens or I do not respond during induction or maintenance?
- Which costs are covered, and is compensation or travel assistance available?
- What adverse effects and monitoring requirements are described in the consent form for icotrokinra?
- Is the appropriate cohort currently open at my preferred site, and can any activities be completed locally or remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease now, and what risks could come from changing or pausing my current treatment for this study?
- What approved treatment alternatives are reasonable for me if I do not pursue this study?
- Do my prior surgeries, strictures, fistulas, stoma status, or other Crohn’s complications raise concerns about the study criteria or procedures?
- How might repeated bowel preparation, ileocolonoscopy, biopsy, or sedation affect my current health and care plan?
- How should you and the research team coordinate disease monitoring, routine care, medication decisions, and treatment if my symptoms worsen?
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 study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- 77242113CRD3001
- 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
- Adult, Older Adult
Study arms
Experimental
Induction Study 1: Icotrokinra Dose 1
Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Interventions: Drug: Icotrokinra
Experimental
Induction Study 1: Icotrokinra Dose 2
Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Interventions: Drug: Icotrokinra
Placebo Comparator
Induction Study 1: Placebo
Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Interventions: Drug: Placebo
Experimental
Induction Study 2: Icotrokinra
Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Interventions: Drug: Icotrokinra
Placebo Comparator
Induction Study 2: Placebo
Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Interventions: Drug: Placebo
Experimental
Maintenance Study: Icotrokinra Dose 1
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Interventions: Drug: Icotrokinra
Experimental
Maintenance Study: Icotrokinra Dose 2
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Interventions: Drug: Icotrokinra
Placebo Comparator
Maintenance Study: Placebo
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Interventions: Drug: Icotrokinra, Drug: Placebo
Interventions
Drug
Icotrokinra
Icotrokinra will be administered orally, daily.
Drug
Placebo
Matching placebo will be administered orally, daily.
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (5)
- Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CDRegistry-derived · unreviewed
- Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2Registry-derived · unreviewed
- Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segmentsRegistry-derived · unreviewed
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (ADT-inadequate responder \[IR\]) as defined in the protocolRegistry-derived · unreviewed
Exclusion criteria (5)
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study interventionRegistry-derived · unreviewed
- Presence of a stoma or ostomyRegistry-derived · unreviewed
- Participants with presence of active fistulas may be included if there is no surgery neededRegistry-derived · unreviewed
- Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baselineRegistry-derived · unreviewed
- Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomizationRegistry-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
Induction Study 1: Number of Participants with Clinical Response at Week 12
Time frame: At Week 12
Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Primary outcome
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
Time frame: At Week 12
Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Primary outcome
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
Time frame: At Week 12
Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Primary outcome
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
Time frame: At Week 40
Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Primary outcome
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
Time frame: At Week 40
Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Secondary outcome
Induction Study 1: Number of Participants with Clinical Remission at Week 12
Time frame: At Week 12
Clinical remission is defined as CDAI score \< 150. CDAI scores ranging from 0 to approximately 600. Higher score indicates higher disease activity.
Secondary outcome
Induction Study 1: Number of Participants with Endoscopic Response at Week 12
Time frame: At Week 12
Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
Secondary outcome
Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)
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. An 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
Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12
Time frame: At Week 12
PRO-2 remission is defined as an abdominal pain (AP) mean daily score less than or equal to (\<=) 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.
Secondary outcome
Induction Study 2: Number of Participants with Clinical Response at Week 12
Time frame: At Week 12
Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.
Secondary outcome
Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12
Time frame: At Week 12
Clinical remission is defined as CDAI score \< 150. Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.
Secondary outcome
Induction Study 2: Number of Participants with Clinical Response at Week 4
Time frame: At Week 4
Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.
Secondary outcome
Induction Study 2: Number of Participants with Endoscopic Remission at Week 12
Time frame: At Week 12
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Secondary outcome
Induction Study 2: Number of Participants with Deep Remission at Week 12
Time frame: At Week 12
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150-point. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Secondary outcome
Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Time frame: At Week 12
IBDQ remission is defined as IBDQ score \>= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (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
Induction Study 2: Number of Participants with Fatigue Response at Week 12
Time frame: At Week 12
Fatigue response is defined as a \>= 7 point reduction in the patient reported outcomes measurement information system (PROMIS)-Fatigue Short Form 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). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.
Secondary outcome
Induction Study 2: Number of Participants with Clinical Remission at Week 4
Time frame: At Week 4
Clinical remission is defined as CDAI score\< 150.
Secondary outcome
Induction Study 2: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 12
Time frame: At Week 12
Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.
Secondary outcome
Induction Study 2: Number of Participants with AEs and SAEs
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)
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. An 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
Maintenance Study: Number of Participants with PRO-2 remission at Week 40
Time frame: At Week 40
PRO-2 remission is defined as an abdominal pain (AP) mean daily score \<= 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.
Secondary outcome
Maintenance Study: Number of Participants with Endoscopic Remission at Week 40
Time frame: At Week 40
Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Secondary outcome
Maintenance Study: Number of Participants with 90-Day Corticosteroid-Free Clinical Remission at Week 40
Time frame: At Week 40
90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for at least 90 days prior to the visit. Clinical remission is defined as CDAI score \< 150.
Secondary outcome
Maintenance Study: Number of Participants with Maintenance of Clinical Remission at Week 40
Time frame: At Week 40
Participants with clinical remission at Week 40 among those with clinical remission at Week 0 of the maintenance study will be analyzed. Clinical remission is defined as CDAI score \< 150.
Secondary outcome
Maintenance Study: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 40
Time frame: At Week 40
Clinical remission is defined as CDAI score \< 150. Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.
Secondary outcome
Maintenance Study: Number of Participants with Deep Remission at Week 40
Time frame: At Week 40
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.
Secondary outcome
Maintenance Study: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 40
Time frame: At Week 40
Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.
Secondary outcome
Maintenance Study: Number of Participants with IBDQ Remission at Week 40
Time frame: At Week 40
IBDQ remission is defined as IBDQ score \>= 170. 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
Maintenance Study: Number of Participants with Fatigue Response at Week 40
Time frame: At Week 40
Fatigue response is defined as a \>= 7 point reduction in the PROMIS-Fatigue Short Form 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). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.
Secondary outcome
Maintenance Study : Number of Participants with AEs and SAEs
Time frame: Up to 4 weeks after last dose of study drug (i.e., up to Week 44)
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. An 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
Alliance Research Institute, LLC - Canoga Park
RecruitingCanoga Park, California, 91304, United States
Southern California Research Center
RecruitingCoronado, California, 92118, United States
Om Research, LLC 1
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
American Institute of Research
RecruitingCutler Bay, Florida, 33157, United States
Nature Coast Clinical Research
RecruitingInverness, Florida, 34452, United States
Green Leaf Clinical Trials
RecruitingJacksonville, Florida, 32258, United States
Florida Research Center Inc.
RecruitingLakewood Rch, Florida, 34211, United States
Sanchez Clinical Research, Inc
RecruitingMiami, Florida, 33157-6575, United States
GCP Clinical Research
RecruitingTampa, Florida, 33609, 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
Kansas Gastroenterology, LLC
RecruitingWichita, Kansas, 67226, United States
Tri-State Gastroenterology Assoc
RecruitingCrestview Hills, Kentucky, 41017, United States
Gastroenterology Clinic of Acadiana
RecruitingLafayette, Louisiana, 70503, 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
Mayo Clinic 1
RecruitingRochester, Minnesota, 55905, United States
Westchester Putnam Gastroenterology
RecruitingCarmel, New York, 10512, 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
Baylor University Medical Center
RecruitingDallas, Texas, 75246, United States
UT Southwestern Medical Center
RecruitingDallas, Texas, 75390, 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 309 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Sep 29, 2025
- Primary completion
- Sep 19, 2028
- Overall completion
- Oct 6, 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.