Ulcerative Colitis
Vedolizumab With Tofacitinib for Adults With Active Ulcerative Colitis
This Phase 4 study is investigating remission and response after vedolizumab plus tofacitinib, followed by vedolizumab alone for responders, in adults with moderately to severely active ulcerative colitis.
Registry title: A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
37 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- Vedolizumab or Tofacitinib
- Design
- Not provided
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
Among adults with moderately to severely active ulcerative colitis, how often does eight weeks of vedolizumab plus tofacitinib produce clinical remission, and what happens during subsequent vedolizumab-only treatment for responders?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65 with ulcerative colitis.
- The study is looking for people whose ulcerative colitis was confirmed at least three months before screening by clinical, endoscopic, and pathology evidence.
- The study is looking for people with moderately to severely active disease meeting specified Mayo score, rectal bleeding, and endoscopy thresholds.
- Treatment-history rules generally require failure or intolerance of one or two tumor necrosis factor antagonists, but an interim-analysis note may allow some people without prior biologic exposure; the study team must confirm.
- The trial is being conducted at multiple sites in the United States and Canada.
Participation overview
What participation may involve
All participants receive vedolizumab infusions plus oral tofacitinib for eight weeks and are assessed for response. Week 8 responders continue with vedolizumab alone, followed by safety follow-up. What participation may involve: - Receive 300-milligram vedolizumab intravenous infusions at Weeks 0, 2, and 6. - Take 10-milligram tofacitinib tablets by mouth twice daily from Week 0 through Week 8. - Undergo a response assessment at Week 8; responders transition to vedolizumab alone every eight weeks through Week 46. - Complete disease-activity, laboratory, stool-marker, quality-of-life, fatigue, and safety assessments at reported study timepoints. The registry states that overall participation may last up to 76 weeks, including 26 weeks of safety follow-up after the last study-drug dose.
Study interventions
What participants may receive or do
- Vedolizumab: Vedolizumab is given by intravenous infusion at Weeks 0, 2, and 6. Participants with a clinical response at Week 8 continue vedolizumab infusions every eight weeks through Week 46.
- Tofacitinib: Tofacitinib is taken as a 10-milligram tablet by mouth twice daily from Week 0 through Week 8 alongside vedolizumab.
Study design
How the comparison works
This is an open-label Phase 4 study in which approximately 65 participants enter one treatment group. Everyone receives the two-drug regimen initially, and only Week 8 responders transition to vedolizumab alone. Participants are not randomly assigned because the registry describes a single treatment group and lists allocation as not applicable. The study is open-label, meaning the registry reports no masking. The registry lists only one experimental treatment group and does not describe a separate control group. No placebo intervention or placebo group is listed in the registry record.
Reported activities
Procedures and tests
- Screening confirmation of ulcerative colitis may involve review of clinical findings, endoscopy, and a pathology report.
- Disease activity is assessed with complete, partial, or modified Mayo scores, including stool frequency, rectal bleeding, physician assessment, and endoscopic findings as applicable.
- Endoscopic mucosal healing is assessed at Week 52 using the Mayo endoscopic subscore.
- Histological remission is assessed at Week 52 using the Geboes score.
- C-reactive protein, a blood marker of inflammation, is measured at baseline and several study weeks.
- Fecal calprotectin, a stool marker of intestinal inflammation, is measured at baseline and several study weeks.
- Participants complete the 32-question Inflammatory Bowel Disease Questionnaire about symptoms and quality of life.
- Participants complete the 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire.
- Safety monitoring includes adverse-event collection, vital signs, and physical examinations.
- Standard laboratory testing includes clinical chemistry, hematology, coagulation, and urinalysis.
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
- Participants must be 18 through 65 years old.
- Ulcerative colitis must have been confirmed at least three months before screening using clinical and endoscopic evidence supported by a pathology report.
- Disease must be moderately to severely active at screening, with a complete Mayo score of 6 to 12, rectal bleeding subscore of at least 1, and centrally assessed endoscopic subscore of at least 2.
- Ulcerative colitis must extend at least 15 centimeters proximally from the rectum.
- People with extensive colitis or pancolitis lasting more than eight years, or left-sided colitis lasting more than 12 years, need documentation of surveillance colonoscopy within 12 months before initial screening.
- The stated treatment-history rule requires inadequate response, loss of response, or intolerance to at least one but no more than two tumor necrosis factor-alpha antagonists, although an interim-analysis note describes a possible exception for some people without prior biologic exposure.
- If taking oral corticosteroids, participants must be on a stable permitted dose for at least two weeks before screening endoscopy and agree to the required taper after enrollment.
Possible reasons someone may not be able to join
- People with acute severe ulcerative colitis cannot participate.
- Extensive colon removal, subtotal or total colectomy, an ileostomy or colostomy, fixed symptomatic intestinal narrowing, or short bowel syndrome excludes participation.
- Clinical evidence of an abdominal abscess or toxic megacolon excludes participation.
- Other specified forms or causes of colitis, current or previous colonic mucosal dysplasia, and untreated bile acid malabsorption are excluded.
- An active systemic infection during screening excludes participation, subject to the stated investigator exception for some nonsystemic infections.
- Active or latent tuberculosis is excluded regardless of treatment history, based on the registry's listed history and screening-test criteria.
- Positive hepatitis B or hepatitis C testing, active cytomegalovirus infection, or a recent unresolved intestinal infection excludes participation.
- Recent use of specified immunomodulators or immunosuppressants is excluded: immunomodulators within four weeks or immunosuppressants within eight weeks before the first dose.
- Specified recent cardiovascular or clotting conditions—including a stroke, heart attack, coronary stent, or severe heart failure within six months, prior blood clots, or inherited high-clotting risk—exclude participation.
- A history of lymphoma or another lymphoproliferative disease, or signs suggesting one, excludes participation.
Important unknowns
What the record does not make clear
- The registry gives treatment and assessment weeks but does not provide a complete visit schedule or identify which visits may require in-person attendance.
- The record provides rules for corticosteroids and excludes some recent therapies, but it does not fully explain which ulcerative colitis medicines may continue during the study.
- Several medication timing restrictions are listed, but the record does not provide a complete individualized washout plan for all prior therapies.
- The registry does not state what rescue treatment is available if ulcerative colitis worsens.
- The record requires endoscopic evidence at screening and reports endoscopic outcomes, but it does not clearly state the full number, timing, preparation, or sedation arrangements for study endoscopies.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report whether transportation, lodging, parking, or other travel support is available.
- The overall study and listed locations are marked recruiting, but the record cannot confirm current openings or capacity for a particular person at a chosen site.
- The treatment-history criterion says prior failure or intolerance to biologics is required, while an interim-analysis note says some people without prior biologic exposure may be enrolled.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and which visits require travel to the study site?
- How many endoscopies are required, at what weeks, and what preparation, sedation, and recovery time should participants expect?
- Which ulcerative colitis medicines can continue, which must stop, and what washout periods apply?
- What happens after Week 8 for a participant who does not meet the study's clinical-response definition?
- What treatment or urgent-care plan is available if ulcerative colitis worsens during the study?
- Which treatment-history rule is currently active at this site for people without prior biologic exposure?
- Which study-related costs are covered, could anything be billed to insurance, and are compensation or travel reimbursements available?
- Is the preferred site currently enrolling and able to screen new participants?
Before changing care
Questions for your gastroenterologist
- How might the study's required corticosteroid taper or other medication restrictions affect my current treatment plan and disease stability?
- How do vedolizumab plus tofacitinib and the study's monitoring requirements fit with my medical history and current risks?
- What approved treatment alternatives could I consider if I do not pursue this study or if I do not respond at Week 8?
- Does my recent disease course appear stable enough to discuss screening without delaying needed clinical care?
- How should my gastroenterology team and the research team coordinate medication changes, laboratory monitoring, endoscopies, and care if 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 main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
The drugs being tested in this study are called Vedolizumab and Tofacitinib. Vedolizumab and Tofacitinib dual targeted therapy is being tested to treat people with moderate to severe ulcerative colitis (UC) who have experienced inadequate response, loss of response or intolerance to no more than 2 prior tumor necrosis factor (TNF) antagonists. This study will look at the clinical remission in people who take Vedolizumab and Tofacitinib dual targeted therapy. The study will enroll approximately 65 patients. All the participants will be enrolled in a single treatment group to receive dual targeted treatment with Vedolizumab and Tofacitinib for the first 8 weeks: Vedolizumab 300 mg + Tofacitinib 10 mg Only those participants who show a clinical response at Week 8 will transition to Vedolizumab monotherapy for 44 weeks. This multi-center trial will be conducted in the United States and Canada. The overall duration of the study is up to 76 weeks. Participants will be followed up for 26 weeks after the last dose of the study drug for safety.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- Vedolizumab-4054
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Vedolizumab 300 mg + Tofacitinib 10 mg
Participants will receive Vedolizumab 300 mg, intravenous (IV) infusion, at Week 0, Week 2 and Week 6 along with Tofacitinib 10 mg, tablets, orally, twice daily from Week 0 to Week 8. Participants with clinical response at Week 8 will transition to receive vedolizumab 300 mg IV infusion every 8 weeks (Q8W) through Week 46.
Interventions: Drug: Vedolizumab, Drug: Tofacitinib
Interventions
Drug
Vedolizumab
Vedolizumab IV infusions
Drug
Tofacitinib
Tofacitinib Tablets
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (8)
- Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.Registry-derived · unreviewed
- Has moderately to severely active UC as determined by a complete Mayo score \[including physician's global assessment (PGA)\] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.Registry-derived · unreviewed
- Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\].Registry-derived · unreviewed
- Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.Registry-derived · unreviewed
- Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.Registry-derived · unreviewed
- Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.Registry-derived · unreviewed
- Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor.Registry-derived · unreviewed
- If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.Registry-derived · unreviewed
Exclusion criteria (32)
- Has any of the following UC-related complications:Registry-derived · unreviewed
- Acute severe UC.Registry-derived · unreviewed
- The participant has had extensive colonic resection, subtotal or total colectomy.Registry-derived · unreviewed
- The participant has clinical evidence of abdominal abscess or toxic megacolon.Registry-derived · unreviewed
- The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.Registry-derived · unreviewed
- Short bowel syndrome.Registry-derived · unreviewed
- Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Participants with a history of colonic mucosal dysplasia are also excluded.Registry-derived · unreviewed
- Has uncontrolled primary sclerosing cholangitis.Registry-derived · unreviewed
- Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant.Registry-derived · unreviewed
- Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:Registry-derived · unreviewed
- History of TB.Registry-derived · unreviewed
- A diagnostic TB test performed during screening that is positive, as defined by:Registry-derived · unreviewed
- A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of \>15 mg daily prednisone).Registry-derived · unreviewed
- A positive test for hepatitis B virus (HBV).Registry-derived · unreviewed
- A positive test for hepatitis C virus (HCV).Registry-derived · unreviewed
- Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment. Participants who test positive for C. difficile or other intestinal pathogens at screening and receive treatment may be enrolled or rescreened (if required) following confirmation of infection resolution.Registry-derived · unreviewed
- Evidence of active Cytomegalovirus (CMV) infection at screening.Registry-derived · unreviewed
- Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose.Registry-derived · unreviewed
- Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening.Registry-derived · unreviewed
- Has received any of the following medical therapies for UC:Registry-derived · unreviewed
- IV antibiotics within 8 weeks prior to enrollment.Registry-derived · unreviewed
- Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.Registry-derived · unreviewed
- Chronic NSAID use defined as daily use for \>2 consecutive weeks (Note: occasional use \[\<2 consecutive weeks\] of NSAIDs and acetaminophen \[\<100 mg daily\] for headache, arthritis, myalgias, or menstrual cramps and chronic low dose aspirin use \[81-162.5 mg daily\] for cardiovascular prophylaxis are permitted).Registry-derived · unreviewed
- Has received a live virus or live bacterial vaccine within 4 weeks prior to enrollment or planned vaccination during the study and for 12 weeks after last dose.Registry-derived · unreviewed
- Has any of the following cardiovascular or thrombotic conditions:Registry-derived · unreviewed
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.Registry-derived · unreviewed
- Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).Registry-derived · unreviewed
- Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.Registry-derived · unreviewed
- Known inherited conditions that predispose to hypercoagulability.Registry-derived · unreviewed
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.Registry-derived · unreviewed
- A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.Registry-derived · unreviewed
- Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.Registry-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
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score
Time frame: At Week 8
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score
Time frame: At Week 52
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score
Time frame: At Weeks 8, 14 and 26
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1. Partial Mayo Score consists of 3 variables of the Mayo Clinic Score: stool frequency, rectal bleeding and PGA. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.
Secondary outcome
Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo Score
Time frame: At Weeks 2, 6, 8, 14, 26, and 52
Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline or a partial Mayo score of ≥2 points and ≥25% from baseline, if the complete Mayo score was not performed at the visit with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo Score
Time frame: At Weeks 8 and 52
Clinical remission based on modified Mayo Score is where a participant achieves component modified Mayo score of ≤2 with modified MES ≤1, rectal bleeding = 0, and stool frequency ≤1. Modified Mayo Score consists of 3 variables: stool frequency, rectal bleeding and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.
Secondary outcome
Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52
Time frame: At Week 8 and Week 52
Durable clinical remission is defined as the clinical remission at Week 8 and Week 52. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore \>1 point at Weeks 8 and 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 8
Time frame: At Week 8
Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore \>1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8
Time frame: At Week 8
Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 8. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore \>1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52
Time frame: At Week 52
Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore \>1 point at Week 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52
Time frame: At Week 52
Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 52, and was off corticosteroids at least 3 months prior to Week 52. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore \>1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants Achieving Clinical Response at Week 8
Time frame: At Week 8
Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.
Secondary outcome
Percentage of Participants With Mucosal Healing Based on MES at Week 52
Time frame: At Week 52
Mucosal healing is defined as MES ≤1 point at Week 52. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy were 0= Normal appearance of mucosa, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants With Histological Remission Based on Geboes Score at Week 52
Time frame: At Week 52
Histological remission is defined as Geboes score \<2 at Week 52. The Geboes score is a histological grading system for assessing histological disease activity in UC. The Geboes score evaluates 7 histological features. It consists of 6 grades (0-6). Each of the grades is divided into subgrades, based on the severity of tissue abnormalities or the extent of inflammatory cell infiltration. The Geboes score ranges from 0.0 to 5.4, and higher grades are indicative of more severe disease activity.
Secondary outcome
Change in C-Reactive Protein Levels (CRP) From Baseline
Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52
CRP is a useful marker of inflammation in participants with inflammatory bowel disease (IBD). In participants with UC, elevated CRP has been associated with severe clinical activity.
Secondary outcome
Change in Fecal Calprotectin Concentrations From Baseline
Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52
Fecal calprotectin is a biomarker for intestinal inflammatory activity.
Secondary outcome
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Time frame: At Weeks 8, 26 and 52
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Secondary outcome
Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline
Time frame: At Weeks 8, 26 and 52
The FACIT-F is a validated, 13-item questionnaire to assess fatigue in participants with a variety of chronic illnesses, including participants with IBD. Items are rated on a 5-point Likert scale and the total score ranges from 0 to 52 with lower scores representing greater fatigue.
Secondary outcome
Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time frame: Up to 76 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention.
Secondary outcome
Number of Participants With Clinically Significant Change in Vital Signs From Baseline
Time frame: Up to 76 Weeks
Vital signs will include body temperature, respiratory rate, blood pressure (resting more than 5 minutes), and pulse (resting more than 5 minutes).
Secondary outcome
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: At Baseline and From Week 14 to Week 72
A baseline physical examination (defined as the assessment before first dose of study medication) will consist of the following body systems: general appearance; HEENT (head, eyes, ears, nose, and throat); cardiovascular system; respiratory system; gastrointestinal system; dermatologic system; extremities; musculoskeletal system; nervous system; lymph nodes; and other. All subsequent physical examinations will assess clinically significant changes from the assessment prior to first dose examination.
Secondary outcome
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: Up to Week 76
Standard laboratory tests will include clinical chemistry, hematology, coagulation and urinalysis.
Recruiting locations in the United States
Digestive Health Specialsits
RecruitingDothan, Alabama, 36301, United States
Site Contact334-836-1212Ralbares.research@dothangi.com
Robert Albares
GI Alliance Sun City
RecruitingSun City, Arizona, 85351, United States
Site Contact623-972-2116CTrivedi@arizonadigestivehealth.com
Chirag Trivedi
Cedars-Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
Site Contact310-423-4100Andres.Yarur@cshs.org
Andres Yarur
Hoag Hospital Newport Beach
RecruitingNewport Beach, California, 92663, United States
Site Contact323-442-6151aroline.hwang@usc.edu
Caroline Hwang
Endoscopic Research Inc
RecruitingOrlando, Florida, 32803, United States
Site Contact407-896-1726levinepi@cdhfl.com
Henry Levine
Alliance Clinical Research of Tampa, LLC
RecruitingTampa, Florida, 33615, United States
Site Contact813-515-5400crespo@allianceclinicalresearch.com
Israel Crespo
Gastroenterology Consultants, P.C.
RecruitingRoswell, Georgia, 30076, United States
Site Contact404-596-4480Mel7315@Yahoo.com
Melvin Bullock
University of Chicago Medicine
RecruitingChicago, Illinois, 60637, United States
Site Contact177-384-7414kkearney@bsd.uchicago.edu
David Rubin
University of Kansas Medical Center
RecruitingKansas City, Kansas, 66160, United States
Site Contact913-588-3934tesfandyari@kumc.edu
Tuba Esfandyari
University of Louisville
RecruitingLouisville, Kentucky, 40202, United States
Site Contact502-419-5150gerald.dryden@louisville.edu
Gerald Dryden
GI Alliance
RecruitingMetairie, Louisiana, 70006, United States
Site Contact504-456-8020catinis@metrogi.com
George Catinis
Tulane University
RecruitingNew Orleans, Louisiana, 70112, United States
Site Contact352-265-8971sglover3@tulane.edu
Sarah Glover
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
RecruitingChevy Chase, Maryland, 20815, United States
Site Contact301-652-5520erica.cohen@capitaldigestivecare.com
Erica Cohen
Huron Gastroenterology Associates, P.C.
RecruitingYpsilanti, Michigan, 48197, United States
Site Contact734-434-6262soofin@hurongastro.com
Najm Soofi
MNGI Digestive Health, PA
RecruitingPlymouth, Minnesota, 55446, United States
Site Contact612-871-1145James.Campbell@mngi.com
James Campbell
Mid-America Gastro-Intestinal Consultants
RecruitingKansas City, Missouri, 64111, United States
Site Contact816-561-2000hbownik@gimagic.com
Hillary Bownik
BVL Clinical Research
RecruitingLiberty, Missouri, 64068, United States
Site Contact800-407-9314c.bartalos@bvlresearch.com
Christopher Bartalos
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Site Contact314-273-1947Deepak.parakkal@wustl.edu
Parakkal Deepak
NYU Langone Health
RecruitingNew York, New York, 10016, United States
Site Contact646-754-1899David.Hudesman@nyulangone.org
David Hudesman
Weill Cornell Medical College- New York Presbyterian Hospital
RecruitingNew York, New York, 10065, United States
Site Contact646-697-0985djl9010@med.cornell.edu
Dana Lukin
Digestive Health Partners
RecruitingAsheville, North Carolina, 28801, United States
Site Contact828-254-0881wharlan@ncdhp.com
William Harlan III
University of North Carolina
RecruitingChapel Hill, North Carolina, 27599, United States
Site Contact919-962-3112edward_barnes@med.unc.edu
Edward Barnes
University of Cincinnati
RecruitingCincinnati, Ohio, 45627, United States
Site Contact513-558-5504brookln@ucmail.uc.edu
Loren Brook
Ohio Gastroenterology group, Inc.
RecruitingColumbus, Ohio, 43202, United States
Site Contact614-754-5481research@ohiogastro.com
Ryan Gaible
Gastro Intestinal Research Institute of Northern Ohio, LLC.
RecruitingWestlake, Ohio, 44145, United States
Site Contact440-250-7630mnaem@northshoregastro.org
Mohamed S Naem
Allegheny Health Network
RecruitingWexford, Pennsylvania, 15090, United States
Site Contact412-359-8900Aakash.desai@ahn.org
Aakash Desai
University Gastroenterology
RecruitingProvidence, Rhode Island, 02094, United States
Site Contact401-421-6306Jason.Ferreira@gialliance.com
Ferreira Jason
Sanford Health Research
RecruitingRapid City, South Dakota, 57701, United States
Site Contact605-342-3280Blake.jones@Sanfordhealth.org
Blake Jones
GI Alliance - Digestive Health Associates of Texas
RecruitingDallas, Texas, 75044, United States
Site Contact972-265-8201harry.sarles@gialliance.com
Harry E. Sarles
The University of Texas Health Science Center at Houston
RecruitingHouston, Texas, 77030, United States
Site Contact713-500-6677Andrew.Dupont@uth.tmc.edu
Andrew Dupont
GI Alliance - Mansfield
RecruitingMansfield, Texas, 76063, United States
Site Contact817-877-0888moustafa.youssef@dhat.com
Moustafa Youssef
Gastroenterology Research of San Antonio, LLC
RecruitingSan Antonio, Texas, 78229, United States
Site Contact210-615-3848martinezn2@yahoo.com
Nicholas Martinez
Texas Digestive Disease Consultants (TDDC), Southlake
RecruitingSouthlake, Texas, 76092, United States
Site Contact940-367-2316Tim.Ritter@gialliance.com
Timothy Ritter
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Site Contact903-630-6211Aaron.duvall@iterativehealth.com
George Aaron DuVall
GI Alliance - Webster
RecruitingWebster, Texas, 77598, United States
Site Contact832-754-8163NInamdar@tddctx.com
Nikhil Inamdar
University of Utah Health
RecruitingSalt Lake City, Utah, 84108, United States
Site Contactjohn.valentine@hsc.utah.edu
John Valentine
Washington Gastroenterology- GIA
RecruitingTacoma, Washington, 98405, United States
Site Contact253-272-5127wholderman@washgi.com
William Holderman
This study also lists 9 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 23, 2023
- Primary completion
- Jul 9, 2027
- Overall completion
- Jul 9, 2027
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.