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Evaluating Dupilumab for Active Ulcerative Colitis in Adults

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype

Phase 2 Interventional Sanofi · NCT05731128

This study is testing if a medication called dupilumab can help adults with moderate to severe ulcerative colitis feel better and manage their symptoms.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment84 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations77 sites (Apple Valley, California and 76 other locations)
Trial IDNCT05731128 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is a double-blind, placebo-controlled study designed to assess the efficacy and safety of dupilumab in adults aged 18 and older with moderately to severely active ulcerative colitis (UC) characterized by an eosinophilic phenotype. Participants will undergo a screening period followed by a 52-week treatment phase where they will receive either dupilumab or a matching placebo. The study aims to determine the impact of dupilumab on UC symptoms and overall disease management. An optional open-label arm will allow participants who qualify to receive dupilumab after the initial treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderately to severely active ulcerative colitis who have not responded adequately to standard biologic therapies.

Not a fit: Patients with mild ulcerative colitis or those who have not shown an eosinophilic phenotype may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis for patients with an eosinophilic phenotype.

How similar studies have performed: Previous studies have shown promise with dupilumab in other conditions, suggesting potential success in this novel application for ulcerative colitis.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Apple Valley, California and 76 other locations

+27 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis Ulcerative
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.