An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Purpose
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: - Up to 5-week Screening Period. - 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). - 12-week Sub-Study 3 (Extended Induction for non-responders). - 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.
Condition
- Crohn's Disease
Eligibility
- Eligible Ages
- Between 16 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
Exclusion Criteria
Participants with Ulcerative Colitis (UC) or indeterminate colitis Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum Prior or current high-grade gastrointestinal (GI) dysplasia Participants on treatment with but not on stable doses of conventional therapy prior to baseline Participants receiving prohibited medications or therapies Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Duvakitug Dose 1 |
Subcutaneous (SC) Injection as per protocol |
|
|
Experimental Duvakitug Dose 2 |
SC injection as per protocol |
|
|
Placebo Comparator Placebo |
SC injection as per protocol |
|
Recruiting Locations
Peoria 5308480, Arizona 5551752 85381
Tucson 5318313, Arizona 5551752 85715
Little Rock 4119403, Arkansas 4099753 72211
Canoga Park 5333913, California 5332921 91304
Coronado 5339663, California 5332921 92118-1408
Folsom 5349705, California 5332921 95630
Los Angeles 5368361, California 5332921 90048
Murrieta 5375911, California 5332921 92563
Rancho Cucamonga 5385955, California 5332921 91730
Tarzana 5401143, California 5332921 91356
Thousand Oaks 5402405, California 5332921 91360
Valencia 5405288, California 5332921 91355
Victorville 5406222, California 5332921 92395
Colorado Springs 5417598, Colorado 5417618 80907
Coral Springs 4151909, Florida 4155751 33065
Gainesville 4156404, Florida 4155751 32607
Kissimmee 4160983, Florida 4155751 34741
Miami 4164138, Florida 4155751 33125
Miami 4164138, Florida 4155751 33126
Miami 4164138, Florida 4155751 33155
Miami 4164138, Florida 4155751 33186
Tampa 4174757, Florida 4155751 33607
Sandy Springs 4221333, Georgia 4197000 30328
Snellville 4223413, Georgia 4197000 30078
Glenview 4893886, Illinois 4896861 60031
Gurnee 4894861, Illinois 4896861 60031
New Albany 4262045, Indiana 4921868 47150
Baton Rouge 4315588, Louisiana 4331987 70809
Metairie 4333177, Louisiana 4331987 70006
Monroe 4333669, Louisiana 4331987 71291
Greenbelt 4356847, Maryland 4361885 20770
Wyoming 5015618, Michigan 5001836 49519
Chesterfield 4381072, Missouri 4398678 63017
Liberty 4395052, Missouri 4398678 64068
Sparta 5104882, New Jersey 5101760 07871
Maspeth 5126180, New York 5128638 11378
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10075
Charlotte 4460243, North Carolina 4482348 28211
Fayetteville 4466033, North Carolina 4482348 28304
Monroe 4479946, North Carolina 4482348 28112
Raleigh 4487042, North Carolina 4482348 27612
Fargo 5059163, North Dakota 5690763 58104
Columbus 4509177, Ohio 5165418 43202
Dayton 4509884, Ohio 5165418 45414
Springboro 4525304, Ohio 5165418 45066
Westlake 5176517, Ohio 5165418 44145
Norman 4543762, Oklahoma 4544379 73071
Providence 5224151, Rhode Island 5224323 02904
West Columbia 4600541, South Carolina 4597040 29169
Kingsport 4634662, Tennessee 4662168 37663
Harlingen 4696233, Texas 4736286 78550
Lake Jackson 4704628, Texas 4736286 77566
Lubbock 5525577, Texas 4736286 79410
Southlake 4733313, Texas 4736286 76092
Tomball 4737094, Texas 4736286 77375
Tyler 4738214, Texas 4736286 75701
Lynchburg 4771075, Virginia 6254928 24502
Richmond 4781708, Virginia 6254928 23226
Vancouver 5814616, Washington 5815135 98664
Vega Baja 4568533, Puerto Rico 00693
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Contact-US@sanofi.com