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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))
NCT05731128 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05731128
The ClinicalTrials.gov registry entry for NCT05731128 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05731128 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05731128?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05731128?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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