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))

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Colitis Ulcerative

In brief

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.

Key facts

Study ID

NCT05731128

Run by

Sanofi

People needed

68

Starts

2023-01-12

Expected to finish

2027-02-22

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• 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
• Investigational Site Number : 4100004 — Daegu, Gyeongsangbuk-do, South Korea
• 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
• Om Research- Site Number : 8400029 — Apple Valley, California, United States

Full record on ClinicalTrials.gov

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