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: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must be ≥18 years of age at the time of signing the informed consent.

• Evidence of biomarker enrichment at time of screening.

• Moderately to severely active UC, defined as a baseline modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopic subscore assigned during the concurrent local and central reading of the video endoscopy.

• Has a screening endoscopy with ≥2 endoscopic subscore in the Mayo score component assessment as determined by concurrent local and central reading of the video endoscopy.

• Has a baseline rectal bleeding subscore of ≥1 and baseline a stool frequency score of ≥1 as determined by the Mayo score component assessment.

• Participants with inadequate response/non-response, loss of response, or are intolerant of standard biologic therapy for their UC AND/OR Inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of the following treatments: oral corticosteroids (≤20 mg/day), 5-aminosalicylic acid (ASA) compounds, immunomodulators, small molecules.

Locations
United States
California
Om Research- Site Number : 8400029
RECRUITING
Apple Valley
TLC Clinical Research- Site Number : 8400020
RECRUITING
Beverly Hills
Ventura County Gastroenterology Medical Group- Site Number : 8400028
RECRUITING
Camarillo
Palmtree Clinical Research- Site Number : 8400048
RECRUITING
Palm Springs
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400034
RECRUITING
Thousand Oaks
Florida
Homestead Associates in Research- Site Number : 8400004
RECRUITING
Homestead
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400009
RECRUITING
Miami Lakes
GI PROS Research- Site Number : 8400046
RECRUITING
Naples
Advanced Research Institute - New Port Richey- Site Number : 8400026
RECRUITING
New Port Richey
Digestive Disease Consultants - Orange Park- Site Number : 8400042
RECRUITING
Orange Park
Tellabio International Research Services- Site Number : 8400041
RECRUITING
Pembroke Pines
GCP Clinical Research- Site Number : 8400014
RECRUITING
Tampa
Georgia
Gastroenterology Consultants - Roswell- Site Number : 8400022
RECRUITING
Roswell
North Carolina
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400008
RECRUITING
Charlotte
Care Access - Lumberton- Site Number : 8400018
COMPLETED
Lumberton
New Jersey
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400043
RECRUITING
East Orange
New York
Smart Medical Research Inc- Site Number : 8400037
RECRUITING
Jackson Heights
DiGiovanna Family Care- Site Number : 8400006
RECRUITING
Massapequa
Pennsylvania
UPMC Presbyterian- Site Number : 8400038
RECRUITING
Pittsburgh
Texas
Advanced Gastroenterology Associates, PA- Site Number : 8400047
RECRUITING
Decatur
Katy Integrative Gastroenterology- Site Number : 8400027
RECRUITING
Katy
Medrasa Clinical Research - Medrasa Sherman- Site Number : 8400039
RECRUITING
Sherman
Texas Digestive Disease Consultants - Southlake- Site Number : 8400013
RECRUITING
Southlake
Digestive Health Specialists of Tyler- Site Number : 8400031
RECRUITING
Tyler
Victoria Gastroenterology- Site Number : 8400019
RECRUITING
Victoria
Washington
Washington Gastroenterology - Bellevue- Site Number : 8400025
RECRUITING
Bellevue
Washington Gastroenterology - Tacoma- Site Number : 8400030
RECRUITING
Tacoma
Other Locations
Argentina
Investigational Site Number : 0320002
RECRUITING
Buenos Aires
Investigational Site Number : 0320007
RECRUITING
Buenos Aires
Investigational Site Number : 0320008
RECRUITING
Buenos Aires
Investigational Site Number : 0320006
RECRUITING
Mar Del Plata
Investigational Site Number : 0320001
RECRUITING
San Miguel De Tucumán
Investigational Site Number : 0320004
RECRUITING
San Miguel De Tucumán
Canada
Investigational Site Number : 1240007
RECRUITING
Edmonton
Investigational Site Number : 1240003
RECRUITING
Montreal
Investigational Site Number : 1240006
RECRUITING
Montreal
Investigational Site Number : 1240010
RECRUITING
Scarborough Village
Chile
Investigational Site Number : 1520001
RECRUITING
Concepción
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520003
RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Santiago
Investigational Site Number : 1520006
RECRUITING
Santiago
Japan
Investigational Site Number : 3920004
RECRUITING
Bunkyo
Investigational Site Number : 3920011
RECRUITING
Kamakura
Investigational Site Number : 3920005
RECRUITING
Kashiwa
Investigational Site Number : 3920008
RECRUITING
Kitakyushu
Investigational Site Number : 3920007
RECRUITING
Kyoto
Investigational Site Number : 3920006
RECRUITING
Nagoya
Investigational Site Number : 3920009
RECRUITING
Saitama
Investigational Site Number : 3920001
RECRUITING
Sapporo
Investigational Site Number : 3920002
RECRUITING
Sapporo
Investigational Site Number : 3920010
RECRUITING
Shimizu
Mexico
Investigational Site Number : 4840003
RECRUITING
Chihuahua City
Investigational Site Number : 4840007
RECRUITING
Guadalajara
Investigational Site Number : 4840004
RECRUITING
Mexico City
Investigational Site Number : 4840005
RECRUITING
Saltillo
Investigational Site Number : 4840002
RECRUITING
Torreón
Puerto Rico
University of Puerto Rico - Medical Sciences Campus- Site Number : 6300002
RECRUITING
San Juan
Republic of Korea
Investigational Site Number : 4100004
RECRUITING
Daegu
Investigational Site Number : 4100005
RECRUITING
Daegu
Investigational Site Number : 4100006
RECRUITING
Daejeon
Investigational Site Number : 4100003
RECRUITING
Haeundae-gu
Investigational Site Number : 4100002
RECRUITING
Wŏnju
South Africa
Investigational Site Number : 7100002
RECRUITING
Cape Town
Investigational Site Number : 7100005
RECRUITING
Cape Town
Investigational Site Number : 7100007
RECRUITING
Cape Town
Investigational Site Number : 7100009
RECRUITING
Cape Town
Investigational Site Number : 7100001
RECRUITING
Johannesburg
Investigational Site Number : 7100006
RECRUITING
Johannesburg
Investigational Site Number : 7100008
RECRUITING
Johannesburg
Investigational Site Number : 7100003
RECRUITING
Port Elizabeth
Investigational Site Number : 7100004
RECRUITING
Pretoria
Taiwan
Investigational Site Number : 1580002
COMPLETED
Taichung
Turkey
Investigational Site Number : 7920003
RECRUITING
Gaziantep
Investigational Site Number : 7920005
RECRUITING
Istanbul
Investigational Site Number : 7920001
RECRUITING
Mersin
Investigational Site Number : 7920006
RECRUITING
Zonguldak
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-01-12
Estimated Completion Date: 2027-03-24
Participants
Target number of participants: 84
Treatments
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
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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