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))
Condition(s) studied
Investigational drug(s) / intervention(s)
Dupilumab: injection solution subcutaneous
Placebo: injection solution subcutaneous
Study 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.
Eligibility
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.
On this site
📄 Dupixent (dupilumab) drug profile →More Sanofi trials in South Korea
Other trials for the same condition
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.
View NCT05731128 on ClinicalTrials.gov ↗ ← All trials in South Korea