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))

Part of paid clinical trials in Apple Valley, California.

Sponsor
Sanofi
Study ID
NCT05731128
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Colitis Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    injection solution subcutaneous
  • Placebo — DRUG
    injection solution subcutaneous

Study Details

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.

Key Dates

Start date
Jan 12, 2023
Status verified
Dec 2025
Primary completion
May 15, 2026
Completion
Feb 19, 2027

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Initial loading dose followed by regular administration for the duration of the treatment period.
  • Placebo Comparator: Placebo
    Initial loading dose followed by regular administration for the duration of the treatment period.
  • Other: Open-label arm (optional)
    Regular administration of open label dupilumab

Primary Outcome Measure

Proportion of participants achieving clinical response at Week 24 [ Time Frame: Week 24 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Om Research- Site Number : 8400029Apple ValleyCalifornia92307-
TLC Clinical Research- Site Number : 8400020Beverly HillsCalifornia90211-
Om Research - Oxnard- Site Number : 8400028OxnardCalifornia93036-
Palmtree Clinical Research- Site Number : 8400048Palm SpringsCalifornia92262-
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034Thousand OaksCalifornia91360-
Homestead Associates in Research- Site Number : 8400004HomesteadFlorida33033-
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009Miami LakesFlorida33016-
GI Pros- Site Number : 8400046NaplesFlorida34102-
Advanced Research Institute - New Port Richey- Site Number : 8400026New Port RicheyFlorida34653-
Digestive Disease Consultants - Orange Park- Site Number : 8400042Orange ParkFlorida32073-
Tellabio International Research Services- Site Number : 8400041Pembroke PinesFlorida33025-
GCP Clinical Research- Site Number : 8400014TampaFlorida33609-
Gastroenterology Consultants - Roswell- Site Number : 8400022RoswellGeorgia30076-
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043East OrangeNew Jersey07018-
Smart Medical Research - New York- Site Number : 8400037Jackson HeightsNew York11372-
DiGiovanna Family Care- Site Number : 8400006MassapequaNew York11758-
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008CharlotteNorth Carolina28287-
Care Access - Lumberton- Site Number : 8400018LumbertonNorth Carolina28358-
UPMC Presbyterian- Site Number : 8400038PittsburghPennsylvania15213-
Advanced Gastroenterology Associates - Decatur- Site Number : 8400047DecaturTexas76234-
Katy Integrative Gastroenterology- Site Number : 8400027KatyTexas77494-
Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039ShermanTexas75092-
Texas Digestive Disease Consultants - Southlake- Site Number : 8400013SouthlakeTexas76092-
Digestive Health Specialists of Tyler- Site Number : 8400031TylerTexas75701-
Victoria Gastroenterology- Site Number : 8400019VictoriaTexas77904-
Washington Gastroenterology - Bellevue- Site Number : 8400025BellevueWashington98004-
Washington Gastroenterology - Tacoma- Site Number : 8400030TacomaWashington98405-

Find similar trials in Apple Valley, CA

By research site
Om Research· Apple Valley, CATLC Clinical Research· Beverly Hills, CAOm Research - Oxnard· Oxnard, CAPalmtree Clinical Research· Palm Springs, CAClinical Trials Management Services - Thousand Oaks· Thousand Oaks, CAHomestead Associates in Research· Homestead, FL

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