A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype
Study on the Efficacy and Safety of Investigational Therapy for Ulcerative Colitis
Study Overview
The protocol of this Phase 2 clinical trial consists of a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of dupilumab in participants with moderately to severely active Ulcerative Colitis (UC) with an eosinophilic phenotype.
Screening period: 2 to up to 4 weeks
Treatment period:
52-week investigational medicinal product (IMP) intervention (dupilumab or matching placebo) from Week 0 to Week 52 Open-label arm (optional): administration of open-label dupilumab therapy for study participants who qualify. Follow-up period: 12 weeks The maximum duration of study per participant is up to 68 weeks.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Colitis Ulcerative
-
Age: 18 years or above
-
Gender: All
Inclusion Criteria:
- Participants must be ≥18 years of age at the time of signing the informed consent.
- Evidence of biomarker enrichment at time of screening.
- Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.
- Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.
- Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment.
- Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC AND/OR Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA) compounds, immunomodulators, small molecules.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Severe extensive colitis as evidenced by:
- Current hospitalization
- Likely to require surgery for the treatment of UC within 12 weeks of Screening Visit
- UC limited to the rectum only or to <20 cm of the colon as determined by central
reading.
- Presence of an ileal pouch, ostomy, stoma or fistula or history of a fistula.
- Require, or required within the 2 months before screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study agent treatment.
- Has a prior medical history of eosinophilic colitis.
- Participants with abdominal abscess, fulminant disease, or toxic megacolon.
- Participants with intestinal failure or short bowel syndrome.
- Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy).
- History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity.
- History of colonic mucosal dysplasia or presence of adenomatous colonic polyps not removed OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit.
- If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates the efficacy and safety of an investigational therapy compared to a placebo in adults aged 18 and older with moderately to severely active ulcerative colitis. Participants in this study have an eosinophilic phenotype, meaning they have higher levels of eosinophils, a type of white blood cell, in their colon. The purpose of the study is to assess how well the investigational therapy works in reducing the symptoms of ulcerative colitis and its safety in participants.
The study involves a 52-week treatment period where participants will receive either the investigational therapy or a placebo. During the study, participants may have the option to receive open-label investigational therapy if they qualify. Procedures include regular assessments of ulcerative colitis symptoms and health status through endoscopy and other evaluations.
- Who can participate: Adults aged 18 and older with moderately to severely active ulcerative colitis and an eosinophilic phenotype may participate. Key eligibility includes having a specific range of Mayo scores and either inadequate response or intolerance to standard therapies.
- Study details: Participants will receive either the investigational therapy or a placebo. They will undergo regular assessments, including endoscopic evaluations, to monitor their ulcerative colitis symptoms and overall health.
- Study timelines: The study will last 68 weeks.