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Clinical Trials in the USA / NCT05731128
Active, not recruiting Phase 2

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))

NCT05731128 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2023-01-12
Last updated
2026-06-23

Condition(s) studied

Colitis Ulcerative

Investigational drug(s) / intervention(s)

Dupilumab →Placebo

Dupilumab: injection solution subcutaneous

Placebo: injection solution subcutaneous

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
Om Research- Site Number : 8400029 Apple Valley California
TLC Clinical Research- Site Number : 8400020 Beverly Hills California
Om Research - Oxnard- Site Number : 8400028 Oxnard California
Palmtree Clinical Research- Site Number : 8400048 Palm Springs California
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034 Thousand Oaks California
Homestead Associates in Research- Site Number : 8400004 Homestead Florida
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009 Miami Lakes Florida
GI Pros- Site Number : 8400046 Naples Florida
Advanced Research Institute - New Port Richey- Site Number : 8400026 New Port Richey Florida
Digestive Disease Consultants - Orange Park- Site Number : 8400042 Orange Park Florida
Tellabio International Research Services- Site Number : 8400041 Pembroke Pines Florida
GCP Clinical Research- Site Number : 8400014 Tampa Florida
Gastroenterology Consultants - Roswell- Site Number : 8400022 Roswell Georgia
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043 East Orange New Jersey
Smart Medical Research - New York- Site Number : 8400037 Jackson Heights New York
DiGiovanna Family Care- Site Number : 8400006 Massapequa New York
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008 Charlotte North Carolina
Care Access - Lumberton- Site Number : 8400018 Lumberton North Carolina
UPMC Presbyterian- Site Number : 8400038 Pittsburgh Pennsylvania
Advanced Gastroenterology Associates - Decatur- Site Number : 8400047 Decatur Texas
Katy Integrative Gastroenterology- Site Number : 8400027 Katy Texas
Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039 Sherman Texas
Texas Digestive Disease Consultants - Southlake- Site Number : 8400013 Southlake Texas
Digestive Health Specialists of Tyler- Site Number : 8400031 Tyler Texas
Victoria Gastroenterology- Site Number : 8400019 Victoria Texas
Washington Gastroenterology - Bellevue- Site Number : 8400025 Bellevue Washington
Washington Gastroenterology - Tacoma- Site Number : 8400030 Tacoma Washington
Investigational Site Number : 0320006 Mar del Plata Buenos Aires
Investigational Site Number : 0320001 San Miguel de Tucumán Tucumán Province
Investigational Site Number : 0320004 San Miguel de Tucumán Tucumán Province
Investigational Site Number : 0320007 Buenos Aires Argentina
Investigational Site Number : 0320008 Buenos Aires Argentina
Investigational Site Number : 0320002 Buenos Aires Argentina
Investigational Site Number : 1240007 Edmonton Alberta
Investigational Site Number : 1240010 Scarborough Village Ontario
Investigational Site Number : 1240006 Montreal Quebec
Investigational Site Number : 1240003 Montreal Quebec
Investigational Site Number : 1520001 Concepción Biobio
Investigational Site Number : 1520005 Santiago Reg Metropolitana de Santiago
Investigational Site Number : 1520003 Santiago Reg Metropolitana de Santiago

+ 37 more sites — see the full list on the official registry below.

On this site

📄 Dupixent (dupilumab) drug profile →

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05731128 on ClinicalTrials.gov ↗ ← All trials in the USA