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 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ACT17746U1111-1278-4042
• Study Type: interventional
• Target: 68
• Locations: 11 countries
• Sites: 77

Brief 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.

Conditions

Colitis Ulcerative

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving clinical response at Week 24

  Clinical response by modified Mayo score is defined as a decrease from baseline in the modified Mayo score of ≥2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥1 OR an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Mayo endoscopic subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The total modified Mayo score ranges 0-9 with higher scores indicating greater disease severity.

  Week 24

Secondary Outcomes (14)

• Proportion of participants who are in clinical response at Week 52

  Week 52

• Proportion of participants who are in clinical remission at Week 24 and Week 52

  Week 24 and Week 52

• Proportion of participants in symptomatic remission over time

  Baseline up to Week 52

• Proportion of participants achieving histologic-endoscopic healing at Week 24, and Week 52

  Week 24 and Week 52

• Proportion of participants with a Mayo endoscopic subscore of 0 or 1 without friability at Week 24, and Week 52

  Week 24 and Week 52

Study Arms (3)

Dupilumab

EXPERIMENTAL

Initial loading dose followed by regular administration for the duration of the treatment period.

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Initial loading dose followed by regular administration for the duration of the treatment period.

Drug: Placebo

Open-label arm (optional)

OTHER

Regular administration of open label dupilumab

Drug: Dupilumab

Interventions

Dupilumab DRUG

injection solution subcutaneous

Also known as: Dupixent

Dupilumab; Open-label arm (optional)

Placebo DRUG

injection solution subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (77)

Om Research- Site Number : 8400029

Apple Valley, California, 92307, United States

Location

TLC Clinical Research- Site Number : 8400020

Beverly Hills, California, 90211, United States

Location

Om Research - Oxnard- Site Number : 8400028

Oxnard, California, 93036, United States

Location

Palmtree Clinical Research- Site Number : 8400048

Palm Springs, California, 92262, United States

Location

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

Thousand Oaks, California, 91360, United States

Location

Homestead Associates in Research- Site Number : 8400004

Homestead, Florida, 33033, United States

Location

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

Miami Lakes, Florida, 33016, United States

Location

GI Pros- Site Number : 8400046

Naples, Florida, 34102, United States

Location

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

New Port Richey, Florida, 34653, United States

Location

Digestive Disease Consultants - Orange Park- Site Number : 8400042

Orange Park, Florida, 32073, United States

Location

Tellabio International Research Services- Site Number : 8400041

Pembroke Pines, Florida, 33025, United States

Location

GCP Clinical Research- Site Number : 8400014

Tampa, Florida, 33609, United States

Location

Gastroenterology Consultants - Roswell- Site Number : 8400022

Roswell, Georgia, 30076, United States

Location

Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043

East Orange, New Jersey, 07018, United States

Location

Smart Medical Research - New York- Site Number : 8400037

Jackson Heights, New York, 11372, United States

Location

DiGiovanna Family Care- Site Number : 8400006

Massapequa, New York, 11758, United States

Location

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

Charlotte, North Carolina, 28287, United States

Location

Care Access - Lumberton- Site Number : 8400018

Lumberton, North Carolina, 28358, United States

Location

UPMC Presbyterian- Site Number : 8400038

Pittsburgh, Pennsylvania, 15213, United States

Location

Advanced Gastroenterology Associates - Decatur- Site Number : 8400047

Decatur, Texas, 76234, United States

Location

Katy Integrative Gastroenterology- Site Number : 8400027

Katy, Texas, 77494, United States

Location

Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039

Sherman, Texas, 75092, United States

Location

Texas Digestive Disease Consultants - Southlake- Site Number : 8400013

Southlake, Texas, 76092, United States

Location

Digestive Health Specialists of Tyler- Site Number : 8400031

Tyler, Texas, 75701, United States

Location

Victoria Gastroenterology- Site Number : 8400019

Victoria, Texas, 77904, United States

Location

Washington Gastroenterology - Bellevue- Site Number : 8400025

Bellevue, Washington, 98004, United States

Location

Washington Gastroenterology - Tacoma- Site Number : 8400030

Tacoma, Washington, 98405, United States

Location

Investigational Site Number : 0320006

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Investigational Site Number : 0320001

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320007

Buenos Aires, 1028, Argentina

Location

Investigational Site Number : 0320008

Buenos Aires, 1119, Argentina

Location

Investigational Site Number : 0320002

Buenos Aires, 1125, Argentina

Location

Investigational Site Number : 1240007

Edmonton, Alberta, T5R 1W2, Canada

Location

Investigational Site Number : 1240010

Scarborough Village, Ontario, M1B 3V4, Canada

Location

Investigational Site Number : 1240006

Montreal, Quebec, H1T 2M4, Canada

Location

Investigational Site Number : 1240003

Montreal, Quebec, H3G 1A4, Canada

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 7620001, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

Location

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, 8360156, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8380456, Chile

Location

Investigational Site Number : 1520001

Concepción, Región del Biobío, 4070038, Chile

Location

Investigational Site Number : 3920006

Nagoya, Aichi-ken, 451-8511, Japan

Location

Investigational Site Number : 3920005

Kashiwa, Chiba, 277-0871, Japan

Location

Investigational Site Number : 3920008

Kitakyushu, Fukuoka, 802-0077, Japan

Location

Investigational Site Number : 3920002

Sapporo, Hokkaido, 004-0041, Japan

Location

Investigational Site Number : 3920001

Sapporo, Hokkaido, 065-0033, Japan

Location

Investigational Site Number : 3920011

Kamakura, Kanagawa, 247-0056, Japan

Location

Investigational Site Number : 3920010

Shimizu, Shizuoka, 411-0905, Japan

Location

Investigational Site Number : 3920004

Bunkyo, Tokyo, 113-8510, Japan

Location

Investigational Site Number : 3920007

Kyoto, 605-0981, Japan

Location

Investigational Site Number : 3920009

Saitama, 336-0963, Japan

Location

Investigational Site Number : 4840005

Saltillo, Coahuila, 25020, Mexico

Location

Investigational Site Number : 4840002

Torreón, Coahuila, 27000, Mexico

Location

Investigational Site Number : 4840007

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational Site Number : 4840004

Mexico City, Mexico City, 01120, Mexico

Location

Investigational Site Number : 4840003

Chihuahua City, 31000, Mexico

Location

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

San Juan, 00936, Puerto Rico

Location

Investigational Site Number : 7100005

Cape Town, 7405, South Africa

Location

Investigational Site Number : 7100009

Cape Town, 7500, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7708, South Africa

Location

Investigational Site Number : 7100007

Cape Town, 7800, South Africa

Location

Investigational Site Number : 7100006

Johannesburg, 1821, South Africa

Location

Investigational Site Number : 7100001

Johannesburg, 2193, South Africa

Location

Investigational Site Number : 7100008

Kempton Park, 1619, South Africa

Location

Investigational Site Number : 7100003

Port Elizabeth, 6045, South Africa

Location

Investigational Site Number : 7100004

Pretoria, 0002, South Africa

Location

Investigational Site Number : 4100003

Haeundae-gu, Busan, 48108, South Korea

Location

Investigational Site Number : 4100005

Daegu, Daegu, 41944, South Korea

Location

Investigational Site Number : 4100006

Daejeon, Daejeon, 34943, South Korea

Location

Investigational Site Number : 4100002

Wŏnju, Gangwon-do, 26426, South Korea

Location

Investigational Site Number : 4100004

Daegu, Gyeongsangbuk-do, 42415, South Korea

Location

Investigational Site Number : 1580002

Taichung, 404, Taiwan

Location

Investigational Site Number : 7920003

Gaziantep, 27310, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Istanbul, 34734, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Mersin, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Zonguldak, 67000, Turkey (Türkiye)

Location

Related Links

• ACT17746 Plain Language Results Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 16, 2023
• Study Start: January 12, 2023
• Primary Completion: May 15, 2026
• Study Completion (Estimated): February 19, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (10); CL (5); ZA (9); TU (4); AR (6); US (27); PR (1); ME (5); CA (4); TW (1); KR (5)