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NCT05731128 · ClinicalTrials.gov registry record · Phase 2
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))
A Phase 2 study of Colitis, Ulcerative, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 20
- Study locations
NCT05731128: Active Phase 2 study of Colitis, Ulcerative, sponsored by Sanofi.
NCT05731128 is a Phase 2 study of Colitis, Ulcerative that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 68 participants, below the 403-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05731128, a Phase 2 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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 gr
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
Florida
- Homestead Associates in Research- Site Number : 8400004 - Homestead
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009 - Miami Lakes
- GI Pros- Site Number : 8400046 - Naples
- Advanced Research Institute - New Port Richey- Site Number : 8400026 - New Port Richey
- Digestive Disease Consultants - Orange Park- Site Number : 8400042 - Orange Park
- Tellabio International Research Services- Site Number : 8400041 - Pembroke Pines
- GCP Clinical Research- Site Number : 8400014 - Tampa
California
- Om Research- Site Number : 8400029 - Apple Valley
- TLC Clinical Research- Site Number : 8400020 - Beverly Hills
- Om Research - Oxnard- Site Number : 8400028 - Oxnard
- Palmtree Clinical Research- Site Number : 8400048 - Palm Springs
- Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034 - Thousand Oaks
New York
- Smart Medical Research - New York- Site Number : 8400037 - Jackson Heights
- DiGiovanna Family Care- Site Number : 8400006 - Massapequa
North Carolina
- Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008 - Charlotte
- Care Access - Lumberton- Site Number : 8400018 - Lumberton
Georgia
- Gastroenterology Consultants - Roswell- Site Number : 8400022 - Roswell
New Jersey
- Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043 - East Orange
Pennsylvania
- UPMC Presbyterian- Site Number : 8400038 - Pittsburgh
Texas
- Advanced Gastroenterology Associates - Decatur- Site Number : 8400047 - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2027-02-19 |
| Phase | Phase 2 |
What the registry record for NCT05731128 still lists
NCT05731128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 403-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05731128 names 20 study sites across 8 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT05731128 about?
NCT05731128 is a clinical study titled "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:...
What is the current status of trial NCT05731128?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2023-01-12. Estimated completion is 2027-02-19.
What conditions does trial NCT05731128 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT05731128?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05731128?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05731128 being conducted?
This trial has 20 study locations across California, Florida, Georgia, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05731128's enrollment target sits among peer trials
68 24th of 28 higher than 5 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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