NCT05731128

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, Multi-center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Evaluate the Efficacy and Safety of Dupilumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Colitis Ulcerative

Interventions

Type	Name	Description
DRUG	Dupilumab	injection solution subcutaneous
DRUG	Placebo	injection solution subcutaneous

Timeline

• Start date: 2023-01-12
• Primary completion: 2026-05-15
• Completion: 2027-02-19
• First posted: 2023-02-16
• Last updated: 2025-12-15

Locations

77 sites across 11 countries: United States, Argentina, Canada, Chile, Japan, Mexico, Puerto Rico, South Africa, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study