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))
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)
Proportion of participants achieving clinical response at Week 24 — 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.
Trial sites (77)
Facility
City
Region
Status
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.
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.
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