A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Investigating Treatment for Moderate-to-Severe Atopic Dermatitis

Recruiting
12 years and older
All
Phase 3
496 participants needed
82 Locations

Study Overview

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 atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).

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/or TCI.

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis Atopic
  • Age: 12 Years
  • Gender: All

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 inadequate response 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 potential participation in a clinical trial

Updated on 12 Dec 2024. Study ID: NCT06224348

This study investigates the treatment of moderate-to-severe atopic dermatitis (AD), a skin condition causing red, itchy, and inflamed skin. Participants in this study have not responded well to topical treatments. The study aims to compare the effects of an investigational medication given by injection with a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

Participants will receive either the investigational medication or a placebo while continuing their usual topical treatments. The study will involve regular check-ups and assessments to monitor the safety and effectiveness of the treatment. Participants will be randomly assigned to one of three study arms, ensuring that neither they nor the researchers know which treatment they are receiving.

  • Who can participate: Individuals aged 12 years and older with a diagnosis of atopic dermatitis for at least one year can participate. They must have a history of inadequate response to topical or systemic treatments and meet specific skin condition criteria
  • Study Details: Participants will receive injections of either the investigational medication or a placebo. They will continue using their regular topical treatments
  • Study Timelines and Visits: The study will last up to 44 weeks.The study requires up to 10 visits

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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