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

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

ArmDescriptionAssigned Intervention
Experimental
Amlitelimab dose 1
Subcutaneous injection as per protocol
  • Drug: Amlitelimab
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
    Other names:
    • SAR445229
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
Experimental
Amlitelimab dose 2
Subcutaneous injection as per protocol
  • Drug: Amlitelimab
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
    Other names:
    • SAR445229
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
Placebo Comparator
Placebo
Subcutaneous injection as per protocol
  • Drug: Placebo
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous
  • Drug: Topical corticosteroids
    Pharmaceutical form: Various Topical formulation Route of administration: Topical
  • Drug: Topical tacrolimus or pimecrolimus
    Pharmaceutical form: Various Topical formulation Route of administration: Topical

Recruiting Locations

University of Alabama at Birmingham- Site Number : 8401267
Birmingham 4049979, Alabama 4829764 35233

Center for Dermatology and Plastic Surgery- Site Number : 8401119
Scottsdale 5313457, Arizona 5551752 85260

Arkansas Dermatology- Site Number : 8401244
Little Rock 4119403, Arkansas 4099753 72117

Encino Research Center- Site Number : 8401042
Encino 5346649, California 5332921 91436

Center for Dermatology Clinical Research- Site Number : 8401018
Fremont 5350734, California 5332921 94538

Long Beach Clinical Trials- Site Number : 8401188
Long Beach 5367929, California 5332921 90806

Dermatology Research Associates - Los Angeles- Site Number : 8401092
Los Angeles 5368361, California 5332921 90045

LA Universal Research Center- Site Number : 8401064
Los Angeles 5368361, California 5332921 90057

University Dermatology Trials- Site Number : 8401339
Newport Beach 5376890, California 5332921 92660

Rady Children's Hospital- Site Number : 8401291
San Diego 5391811, California 5332921 92123

Therapeutics Clinical Research- Site Number : 8401283
San Diego 5391811, California 5332921 92123

Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
Wheat Ridge 5443948, Colorado 5417618 80033

Encore Medical Research of Boynton Beach- Site Number : 8401030
Boynton Beach 4148677, Florida 4155751 33436

St. Jude Clinical Research- Site Number : 8401287
Doral 4153471, Florida 4155751 33172

Apex Clinical Research - Jacksonville- Site Number : 8401332
Jacksonville 4160021, Florida 4155751 32256

Global Clinical Professionals (GCP)- Site Number : 8401045
St. Petersburg 4171563, Florida 4155751 33705

Avita Clinical Research- Site Number : 8401073
Tampa 4174757, Florida 4155751 33613

Northwestern University- Site Number : 8401285
Chicago 4887398, Illinois 4896861 60611

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038
Skokie 4911600, Illinois 4896861 60077

Dawes Fretzin Clinical Research- Site Number : 8401015
Indianapolis 4259418, Indiana 4921868 46256

Equity Medical - Bowling Green- Site Number : 8401296
Bowling Green 4285268, Kentucky 6254925 42104

Tandem Clinical Research - Metairie- Site Number : 8401187
Metairie 4333177, Louisiana 4331987 70006

University of Michigan Health System - Ann Arbor- Site Number : 8401290
Ann Arbor 4984247, Michigan 5001836 48109

MI Skin Center- Site Number : 8401307
Northville 5003956, Michigan 5001836 48167

Skin Specialists- Site Number : 8401068
Omaha 5074472, Nebraska 5073708 68144

Schweiger Dermatology Group - East Windsor- Site Number : 8401338
East Windsor 8354649, New Jersey 5101760 08520

The University of New Mexico- Site Number : 8401263
Albuquerque 5454711, New Mexico 5481136 87106

Equity Medical- Site Number : 8401239
New York 5128581, New York 5128638 10023

Sadick Research Group - New York - Park Avenue- Site Number : 8401050
New York 5128581, New York 5128638 10075

Cincinnati Children's Hospital Medical Center- Site Number : 8401279
Cincinnati 4508722, Ohio 5165418 45229

Oregon Health & Science University (OHSU)- Site Number : 8401247
Portland 5746545, Oregon 5744337 97239

Paddington Testing Company- Site Number : 8401041
Philadelphia 4560349, Pennsylvania 6254927 19103

Clinical Research of Philadelphia- Site Number : 8401193
Philadelphia 4560349, Pennsylvania 6254927 19114

Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282
Charleston 4574324, South Carolina 4597040 29425

Arlington Research Center- Site Number : 8401248
Arlington 4671240, Texas 4736286 76011

McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288
Bellaire 4673353, Texas 4736286 77401

Reveal Research Institute - Dallas- Site Number : 8401219
Dallas 4684888, Texas 4736286 75235

Advanced Research Institute - Odgen- Site Number : 8401057
Ogden 5779206, Utah 5549030 84405

Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
Norfolk 4776222, Virginia 6254928 23502

North Sound Dermatology- Site Number : 8401280
Mill Creek 5803457, Washington 5815135 98012

Children's Wisconsin- Site Number : 8401246
Milwaukee 5263045, Wisconsin 5279468 53226

Cheyenne Skin Clinic- Site Number : 8401234
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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.