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 (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Description

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.

Conditions

Colitis Ulcerative

Study Overview

Study Details

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.

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

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 (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab))

Condition
Colitis Ulcerative
Intervention / Treatment

-

Contacts and Locations

Apple Valley

Om Research- Site Number : 8400029, Apple Valley, California, United States, 92307

Beverly Hills

TLC Clinical Research- Site Number : 8400020, Beverly Hills, California, United States, 90211

Camarillo

Om Research- Site Number : 8400028, Camarillo, California, United States, 93012

Thousand Oaks

Clinical Trials Management Service- Site Number : 8400034, Thousand Oaks, California, United States, 91360

Miami Lakes

Wellness Clinical Research - Miami Lakes- Site Number : 8400009, Miami Lakes, Florida, United States, 33016

Miami

Homestead Associates in Research- Site Number : 8400004, Miami, Florida, United States, 33032

New Port Richey

Advanced Research Institute - New Port Richey- Site Number : 8400026, New Port Richey, Florida, United States, 34653

Orange Park

Digestive Disease Consultants- Site Number : 8400042, Orange Park, Florida, United States, 32073

Pembroke Pines

Tellabio International Research Services- Site Number : 8400041, Pembroke Pines, Florida, United States, 33025

Tampa

AdtreMed- Site Number : 8400035, Tampa, Florida, United States, 33607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2026-02-20