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ACTIVE NOT RECRUITING

NCT05731128

PHASE2

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))

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-12

Completion Date

2027-02-19

Last Updated

2025-12-15

Healthy Volunteers

Conditions

Colitis Ulcerative

Interventions

DRUG

Dupilumab

injection solution subcutaneous

DRUG

Placebo

injection solution subcutaneous

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.

Locations (77)

Om Research- Site Number : 8400029

Apple Valley, California, United States

TLC Clinical Research- Site Number : 8400020

Beverly Hills, California, United States

Om Research - Oxnard- Site Number : 8400028

Oxnard, California, United States

Palmtree Clinical Research- Site Number : 8400048

Palm Springs, California, United States

Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034

Thousand Oaks, California, United States

Homestead Associates in Research- Site Number : 8400004

Homestead, Florida, United States

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009

Miami Lakes, Florida, United States

GI Pros- Site Number : 8400046

Naples, Florida, United States

Advanced Research Institute - New Port Richey- Site Number : 8400026

New Port Richey, Florida, United States

Digestive Disease Consultants - Orange Park- Site Number : 8400042

Orange Park, Florida, United States

Tellabio International Research Services- Site Number : 8400041

Pembroke Pines, Florida, United States

GCP Clinical Research- Site Number : 8400014

Tampa, Florida, United States

Gastroenterology Consultants - Roswell- Site Number : 8400022

Roswell, Georgia, United States

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043

East Orange, New Jersey, United States

Smart Medical Research - New York- Site Number : 8400037

Jackson Heights, New York, United States

DiGiovanna Family Care- Site Number : 8400006

Massapequa, New York, United States

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008

Charlotte, North Carolina, United States

Care Access - Lumberton- Site Number : 8400018

Lumberton, North Carolina, United States

UPMC Presbyterian- Site Number : 8400038

Pittsburgh, Pennsylvania, United States

Advanced Gastroenterology Associates - Decatur- Site Number : 8400047

Decatur, Texas, United States

Katy Integrative Gastroenterology- Site Number : 8400027

Katy, Texas, United States

Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039

Sherman, Texas, United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400013

Southlake, Texas, United States

Digestive Health Specialists of Tyler- Site Number : 8400031

Tyler, Texas, United States

Victoria Gastroenterology- Site Number : 8400019

Victoria, Texas, United States

Washington Gastroenterology - Bellevue- Site Number : 8400025

Bellevue, Washington, United States

Washington Gastroenterology - Tacoma- Site Number : 8400030

Tacoma, Washington, United States

Investigational Site Number : 0320006

Mar del Plata, Buenos Aires, Argentina

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, Argentina

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, Canada

Investigational Site Number : 1240010

Scarborough Village, Ontario, Canada

Investigational Site Number : 1240006

Montreal, Quebec, Canada

Investigational Site Number : 1240003

Montreal, Quebec, Canada

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Concepción, Región del Biobío, Chile

Investigational Site Number : 3920006

Nagoya, Aichi-ken, Japan

Investigational Site Number : 3920005

Kashiwa, Chiba, Japan

Investigational Site Number : 3920008

Kitakyushu, Fukuoka, Japan

Investigational Site Number : 3920002

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920001

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920011

Kamakura, Kanagawa, Japan

Investigational Site Number : 3920010

Shimizu, Shizuoka, Japan

Investigational Site Number : 3920004

Bunkyo, Tokyo, Japan

Investigational Site Number : 3920007

Kyoto, Japan

Investigational Site Number : 3920009

Saitama, Japan

Investigational Site Number : 4840005

Saltillo, Coahuila, Mexico

Investigational Site Number : 4840002

Torreón, Coahuila, Mexico

Investigational Site Number : 4840007

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840004

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840003

Chihuahua City, Mexico

University of Puerto Rico - Medical Sciences Campus- Site Number : 6300002

San Juan, Puerto Rico

Investigational Site Number : 7100005

Cape Town, South Africa

Investigational Site Number : 7100009

Cape Town, South Africa

Investigational Site Number : 7100002

Cape Town, South Africa

Investigational Site Number : 7100007

Cape Town, South Africa

Investigational Site Number : 7100006

Johannesburg, South Africa

Investigational Site Number : 7100001

Johannesburg, South Africa

Investigational Site Number : 7100008

Kempton Park, South Africa

Investigational Site Number : 7100003

Port Elizabeth, South Africa

Investigational Site Number : 7100004

Pretoria, South Africa

Investigational Site Number : 4100003

Haeundae-gu, Busan, South Korea

Investigational Site Number : 4100005

Daegu, Daegu, South Korea

Investigational Site Number : 4100006

Daejeon, Daejeon, South Korea

Investigational Site Number : 4100002

Wŏnju, Gangwon-do, South Korea

Investigational Site Number : 4100004

Daegu, Gyeongsangbuk-do, South Korea

Investigational Site Number : 1580002

Taichung, Taiwan

Investigational Site Number : 7920003

Gaziantep, Turkey (Türkiye)

Investigational Site Number : 7920005

Istanbul, Turkey (Türkiye)

Investigational Site Number : 7920001

Mersin, Turkey (Türkiye)

Investigational Site Number : 7920006

Zonguldak, Turkey (Türkiye)

Clinical Research Directory

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))

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (77)