A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Purpose
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 52 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 [RIVER-AD] study).
Condition
- Dermatitis Atopic
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must be at least 12 years of age inclusive, at the time the informed consent is signed. - Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD. - Able and willing to comply with requested study visit and procedures. - Body weight must be ≥ 25 kg.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: - Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols. - Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE). - Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant. - Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study. - Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.). - Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient'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 Amlitelimab dose 1 |
Subcutaneous injection as per protocol |
|
|
Experimental Amlitelimab dose 2 |
Subcutaneous injection as per protocol |
|
|
Placebo Comparator Placebo |
Subcutaneous injection as per protocol |
|
Recruiting Locations
Birmingham, Alabama 35244
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Tucson, Arizona 85745
Fort Smith, Arkansas 72916
Encino, California 91436
Fountain Valley, California 92708
Fremont, California 94538
Huntington Beach, California 92647
Lafayette, California 94549
Lomita, California 90717
Los Angeles, California 90045
Los Angeles, California 90057
Northridge, California 91325
Oxnard, California 93030
Santa Ana, California 92701
Santa Monica, California 90404
Farmington, Connecticut 06032
Coral Gables, Florida 33146
Doral, Florida 33172
Hialeah, Florida 33012
Hollywood, Florida 33024
Miami Lakes, Florida 33014
Miami, Florida 33126
Miami, Florida 33173
Miami, Florida 33173
Pompano Beach, Florida 33060
Saint Petersburg, Florida 33705
Tampa, Florida 33607
Cumming, Georgia 30040
Dawsonville, Georgia 30534
Fayetteville, Georgia 30214
Macon, Georgia 31217
Thomasville, Georgia 31792
Union City, Georgia 30291
Skokie, Illinois 60077
Indianapolis, Indiana 46256
Louisville, Kentucky 40217
Covington, Louisiana 70433
Gretna, Louisiana 70053
Lafayette, Louisiana 70508
Boston, Massachusetts 02215
Needham, Massachusetts 02492
Dearborn, Michigan 48126
Detroit, Michigan 48202
Troy, Michigan 48085
Ypsilanti, Michigan 48197
Ridgeland, Mississippi 39157
Omaha, Nebraska 68144
Las Vegas, Nevada 89106
Hoboken, New Jersey 07030
New York, New York 10023
New York, New York 10029
New York, New York 10075
New York, New York 10128
Fargo, North Dakota 58103
Bexley, Ohio 43209
Cincinnati, Ohio 45246
Mayfield Heights, Ohio 44124
Portland, Oregon 97201
Camp Hill, Pennsylvania 17011
Philadelphia, Pennsylvania 19103
Philadelphia, Pennsylvania 19114
Plymouth Meeting, Pennsylvania 19462
Columbia, South Carolina 29212
Spartanburg, South Carolina 29301-3652
Rapid City, South Dakota 57702
Arlington, Texas 76011
Dallas, Texas 75230
Houston, Texas 77054
Mesquite, Texas 75149
Missouri City, Texas 77459
San Antonio, Texas 78218
Southlake, Texas 76092
Sugar Land, Texas 77479
Bountiful, Utah 84010
Layton, Utah 84041
Arlington, Virginia 22206
Norfolk, Virginia 23502
More Details
- NCT ID
- NCT06407934
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com