A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Purpose
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study 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 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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy. - 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 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 4049979, Alabama 4829764 35233
Scottsdale 5313457, Arizona 5551752 85260
Little Rock 4119403, Arkansas 4099753 72117
Encino 5346649, California 5332921 91436
Fremont 5350734, California 5332921 94538
Long Beach 5367929, California 5332921 90806
Los Angeles 5368361, California 5332921 90045
Los Angeles 5368361, California 5332921 90057
Newport Beach 5376890, California 5332921 92660
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
Wheat Ridge 5443948, Colorado 5417618 80033
Boynton Beach 4148677, Florida 4155751 33436
Doral 4153471, Florida 4155751 33172
Jacksonville 4160021, Florida 4155751 32256
St. Petersburg 4171563, Florida 4155751 33705
Tampa 4174757, Florida 4155751 33613
Chicago 4887398, Illinois 4896861 60611
Skokie 4911600, Illinois 4896861 60077
Indianapolis 4259418, Indiana 4921868 46256
Bowling Green 4285268, Kentucky 6254925 42104
Metairie 4333177, Louisiana 4331987 70006
Ann Arbor 4984247, Michigan 5001836 48109
Northville 5003956, Michigan 5001836 48167
Omaha 5074472, Nebraska 5073708 68144
East Windsor 8354649, New Jersey 5101760 08520
Albuquerque 5454711, New Mexico 5481136 87106
New York 5128581, New York 5128638 10023
New York 5128581, New York 5128638 10075
Cincinnati 4508722, Ohio 5165418 45229
Portland 5746545, Oregon 5744337 97239
Philadelphia 4560349, Pennsylvania 6254927 19103
Philadelphia 4560349, Pennsylvania 6254927 19114
Charleston 4574324, South Carolina 4597040 29425
Arlington 4671240, Texas 4736286 76011
Bellaire 4673353, Texas 4736286 77401
Dallas 4684888, Texas 4736286 75235
Ogden 5779206, Utah 5549030 84405
Norfolk 4776222, Virginia 6254928 23502
Mill Creek 5803457, Washington 5815135 98012
Milwaukee 5263045, Wisconsin 5279468 53226
Cheyenne 5821086, Wyoming 5843591 82009
More Details
- NCT ID
- NCT06241118
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
Contact-US@sanofi.com