A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)
Purpose
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
Condition
- Dermatitis Atopic
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must be 12 years of age (when signing informed consent form) - Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria) - Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening) - v-IGA-AD of 3 or 4 at baseline visit - EASI score of 16 or higher at baseline - AD involvement of 10% or more of BSA at baseline - Weekly average of daily PP-NRS of ≥ 4 at baseline visit. - Able and willing to comply with requested study visits and procedures - Body weight ≥ 25 kg
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: - Skin co-morbidity that would adversely affect the ability to undertake AD assessments - Known history of or suspected significant current immunosuppression - Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline) - History of solid organ or stem cell transplant - Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline - Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit - Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB - Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit - In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening - History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP) 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
Scottsdale, Arizona 85260
Tucson, Arizona 85745
Lomita, California 90717
Los Angeles, California 90045
Mission Viejo, California 92691
Oxnard, California 93030
Santa Monica, California 90404
Farmington, Connecticut 06032
Coral Gables, Florida 33146
Miami, Florida 33176
Tampa, Florida 33607
Columbus, Georgia 31904
Fayetteville, Georgia 30214
Franklin, Kentucky 42134
Covington, Louisiana 70433
Marriottsville, Maryland 21104
Boston, Massachusetts 02111
Jackson, Mississippi 39216
Hoboken, New Jersey 07030
Albuquerque, New Mexico 87106
Bronx, New York 10467
Brooklyn, New York 11220
New York, New York 10023
Fargo, North Dakota 58103
Bexley, Ohio 43209
Cincinnati, Ohio 45246
Plymouth Meeting, Pennsylvania 19462
Upper Saint Clair, Pennsylvania 15241
Rapid City, South Dakota 57702
Arlington, Texas 76011
Dallas, Texas 75235
Houston, Texas 77004
Houston, Texas 77054
Missouri City, Texas 77459
San Antonio, Texas 78229
Arlington, Virginia 22206
Hampton, Virginia 23666
More Details
- NCT ID
- NCT06181435
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com