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))

December 8, 2025 updated by: Sanofi

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1125
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1028
        • Investigational Site Number : 0320007
      • Buenos Aires, Argentina, 1119
        • Investigational Site Number : 0320008
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Investigational Site Number : 0320006
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigational Site Number : 0320001
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigational Site Number : 0320004
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • Investigational Site Number : 1240007
    • Ontario
      • Scarborough Village, Ontario, Canada, M1B 3V4
        • Investigational Site Number : 1240010
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Investigational Site Number : 1240006
      • Montreal, Quebec, Canada, H3G 1A4
        • Investigational Site Number : 1240003
  • Chile
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7620001
        • Investigational Site Number : 1520005
      • Santiago, Reg Metropolitana de Santiago, Chile, 8330034
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 8360156
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380456
        • Investigational Site Number : 1520002
    • Región del Biobío
      • Concepción, Región del Biobío, Chile, 4070038
        • Investigational Site Number : 1520001
  • Japan
      • Kyoto, Japan, 605-0981
        • Investigational Site Number : 3920007
      • Saitama, Japan, 336-0963
        • Investigational Site Number : 3920009
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 451-8511
        • Investigational Site Number : 3920006
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Investigational Site Number : 3920005
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-0077
        • Investigational Site Number : 3920008
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 004-0041
        • Investigational Site Number : 3920002
      • Sapporo, Hokkaido, Japan, 065-0033
        • Investigational Site Number : 3920001
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Investigational Site Number : 3920011
    • Shizuoka
      • Shimizu, Shizuoka, Japan, 411-0905
        • Investigational Site Number : 3920010
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8510
        • Investigational Site Number : 3920004
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Investigational Site Number : 4840003
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25020
        • Investigational Site Number : 4840005
      • Torreón, Coahuila, Mexico, 27000
        • Investigational Site Number : 4840002
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Investigational Site Number : 4840007
    • Mexico City
      • Mexico City, Mexico City, Mexico, 01120
        • Investigational Site Number : 4840004
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico - Medical Sciences Campus- Site Number : 6300002
  • South Africa
      • Cape Town, South Africa, 7405
        • Investigational Site Number : 7100005
      • Cape Town, South Africa, 7500
        • Investigational Site Number : 7100009
      • Cape Town, South Africa, 7708
        • Investigational Site Number : 7100002
      • Cape Town, South Africa, 7800
        • Investigational Site Number : 7100007
      • Johannesburg, South Africa, 1821
        • Investigational Site Number : 7100006
      • Johannesburg, South Africa, 2193
        • Investigational Site Number : 7100001
      • Kempton Park, South Africa, 1619
        • Investigational Site Number : 7100008
      • Port Elizabeth, South Africa, 6045
        • Investigational Site Number : 7100003
      • Pretoria, South Africa, 0002
        • Investigational Site Number : 7100004
  • South Korea
    • Busan
      • Haeundae-gu, Busan, South Korea, 48108
        • Investigational Site Number : 4100003
    • Daegu
      • Daegu, Daegu, South Korea, 41944
        • Investigational Site Number : 4100005
    • Daejeon
      • Daejeon, Daejeon, South Korea, 34943
        • Investigational Site Number : 4100006
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Investigational Site Number : 4100002
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, South Korea, 42415
        • Investigational Site Number : 4100004
  • Taiwan
      • Taichung, Taiwan, 404
        • Investigational Site Number : 1580002
  • Turkey (Türkiye)
      • Gaziantep, Turkey (Türkiye), 27310
        • Investigational Site Number : 7920003
      • Istanbul, Turkey (Türkiye), 34734
        • Investigational Site Number : 7920005
      • Mersin, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920001
      • Zonguldak, Turkey (Türkiye), 67000
        • Investigational Site Number : 7920006
  • United States
    • California
      • Apple Valley, California, United States, 92307
        • Om Research- Site Number : 8400029
      • Beverly Hills, California, United States, 90211
        • TLC Clinical Research- Site Number : 8400020
      • Oxnard, California, United States, 93036
        • Om Research - Oxnard- Site Number : 8400028
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research- Site Number : 8400048
      • Thousand Oaks, California, United States, 91360
        • Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034
    • Florida
      • Homestead, Florida, United States, 33033
        • Homestead Associates in Research- Site Number : 8400004
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009
      • Naples, Florida, United States, 34102
        • GI Pros- Site Number : 8400046
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute - New Port Richey- Site Number : 8400026
      • Orange Park, Florida, United States, 32073
        • Digestive Disease Consultants - Orange Park- Site Number : 8400042
      • Pembroke Pines, Florida, United States, 33025
        • Tellabio International Research Services- Site Number : 8400041
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research- Site Number : 8400014
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Gastroenterology Consultants - Roswell- Site Number : 8400022
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043
    • New York
      • Jackson Heights, New York, United States, 11372
        • Smart Medical Research - New York- Site Number : 8400037
      • Massapequa, New York, United States, 11758
        • DiGiovanna Family Care- Site Number : 8400006
    • North Carolina
      • Charlotte, North Carolina, United States, 28287
        • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008
      • Lumberton, North Carolina, United States, 28358
        • Care Access - Lumberton- Site Number : 8400018
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian- Site Number : 8400038
    • Texas
      • Decatur, Texas, United States, 76234
        • Advanced Gastroenterology Associates - Decatur- Site Number : 8400047
      • Katy, Texas, United States, 77494
        • Katy Integrative Gastroenterology- Site Number : 8400027
      • Sherman, Texas, United States, 75092
        • Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants - Southlake- Site Number : 8400013
      • Tyler, Texas, United States, 75701
        • Digestive Health Specialists of Tyler- Site Number : 8400031
      • Victoria, Texas, United States, 77904
        • Victoria Gastroenterology- Site Number : 8400019
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology - Bellevue- Site Number : 8400025
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology - Tacoma- Site Number : 8400030

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dupilumab
Initial loading dose followed by regular administration for the duration of the treatment period.
Drug: Dupilumab
injection solution subcutaneous
Other Names:
  • Dupixent
Placebo Comparator: Placebo
Initial loading dose followed by regular administration for the duration of the treatment period.
Drug: Placebo
injection solution subcutaneous
Other: Open-label arm (optional)
Regular administration of open label dupilumab
Drug: Dupilumab
injection solution subcutaneous
Other Names:
  • Dupixent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving clinical response at Week 24
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants in symptomatic remission over time
Time Frame: Baseline up to Week 52
Symptomatic remission is defined as Mayo stool frequency score = 0, or Mayo stool frequency score = 1 with a ≥1-point decrease from baseline, and Mayo rectal bleeding score = 0.
Baseline up to Week 52
Change from baseline in the partial Mayo score at Week 8, Week 24, and Week 52
Time Frame: Baseline to Week 8, Week 24 and Week 52
The partial Mayo score consists of 3 subscores; a patient-reported subscore for rectal bleeding, a patient-reported subscore for stool frequency, and a Physician's global assessment (PGA) subscore. Each subscore ranges 0-3 with higher scores indicating greater disease severity. The partial Mayo score ranges 0-9 with higher scores indicating greater disease severity.
Baseline to Week 8, Week 24 and Week 52
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52
Time Frame: Baseline up to Week 52
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. 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.
Baseline up to Week 52
Proportion of participants in clinical remission at Week 52 who are off concomitant oral corticosteroids (OCS) at least 4 weeks prior to Week 52 among participants receiving OCS at baseline
Time Frame: Baseline up to Week 52
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. 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.
Baseline up to Week 52
Change from baseline in abdominal pain assessed by Abdominal Pain Numerical Rating Scale (NRS) at Week 8, Week 24, and Week 52
Time Frame: Baseline to Week 8, Week 24 and Week 52
Abdominal pain NRS is a single item patient report outcome (PRO) tool that patients will use to report intensity of their worst abdominal pain during a daily recall period with 0 being 'no pain' and 10 being the 'worst pain imaginable'.
Baseline to Week 8, Week 24 and Week 52
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time Frame: Baseline up to Week 64
Baseline up to Week 64
Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab.
Time Frame: Baseline up to Week 64
Baseline up to Week 64
Change from baseline (Screening visit) in the normalized enrichment scores (NES) in type 2 inflammation transcriptome signature at Week 24 and Week 52.
Time Frame: Baseline to Week 24 and Week 52
NES is a summary score of the expression of a specified set of genes defining a molecular phenotype.
Baseline to Week 24 and Week 52
Concentration of dupilumab in serum over time.
Time Frame: Baseline up to Week 64
Baseline up to Week 64
Proportion of participants achieving histologic-endoscopic healing at Week 24, and Week 52
Time Frame: Week 24 and Week 52
Histologic-endoscopic healing is defined by Mayo endoscopic subscore of 0 or 1 and histological healing (Geboes score <2). Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity. The Geboes Index score is a six-grade classification system for inflammation: Grade 0 - structural change only; Grade 1 -chronic inflammation; Grade 2 - lamina propria neutrophils; Grade 3 - neutrophils in epithelium; Grade 4 - crypt destruction; and Grade 5 - erosions or ulcers.
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
Time Frame: Week 24 and Week 52
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Week 24 and Week 52
Proportion of participants with a Mayo endoscopic subscore of 0 at Week 24, and Week 52
Time Frame: Week 24 and Week 52
The Mayo endoscopic subscore ranges 0-3 with higher scores indicating greater disease severity.
Week 24 and Week 52
Proportion of participants who are in clinical response at Week 52
Time Frame: Week 52
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 52
Proportion of participants who are in clinical remission at Week 24 and Week 52
Time Frame: Week 24 and Week 52
Clinical remission by modified Mayo score is defined as a modified Mayo score of ≤2 with a stool frequency score ≤1, a rectal bleeding score = 0, AND a Mayo endoscopic subscore ≤1 with absence of friability. 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 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

February 19, 2027

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT17746
  • U1111-1278-4042 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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