Actively Recruiting
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Led by Sanofi · Updated on 2026-05-14
751
Participants Needed
15
Research Sites
425 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
T
Teva Branded Pharmaceutical Products R&D LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
CONDITIONS
Official Title
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 80 years at baseline (participants 16 to under 18 years allowed if Tanner stage 5)
- Participants who achieved clinical response and completed endoscopy in the STARSCAPE-1 study for the Pivotal Maintenance Sub-Study
- Participants who complete the Pivotal Maintenance Sub-Study or the TV48574-IMM-20038 study for the Open-Label Extension Sub-Study
You will not qualify if you...
- Participants with medical or compliance conditions deemed unsuitable by the investigator
- Participants with known hypersensitivity to duvakitug making them unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
2
Clinical Research of Osceola-Site Number: 8400013
Kissimmee, Florida, United States, 34741
Actively Recruiting
3
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
Miami, Florida, United States, 33175
Actively Recruiting
4
NMC Research LLC-Site Number: 8400033
Tampa, Florida, United States, 33607
Actively Recruiting
5
GI Alliance - Baton Rouge-Site Number: 8400129
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
6
Gateway Gastroenterology-Site Number: 8400097
St Louis, Missouri, United States, 63141
Actively Recruiting
7
NYU Langone Health-Site Number: 8400091
New York, New York, United States, 10016
Actively Recruiting
8
New York Gastroenterology Associates-Site Number: 8400009
New York, New York, United States, 10075
Actively Recruiting
9
Cross Creek Medical Clinic-Site Number: 8400057
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
10
Ohio Gastroenterology Group Inc.-Site Number: 8400006
Columbus, Ohio, United States, 43202
Actively Recruiting
11
OSU Wexner Medical Center-Site Number: 8400077
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
San Antonio, Texas, United States, 78229
Actively Recruiting
13
Tyler Research Institute LLC-Site Number: 8400095
Tyler, Texas, United States, 75701
Actively Recruiting
14
Gastroenterology Associates of Western Michigan-Site Number: 8400060
Wyoming, Wyoming, United States, 49519
Actively Recruiting
15
Investigational Site Number : 1240003
Toronto, Canada, M6A 3B4
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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