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 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 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, Alabama 35233

More Details

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.