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)

Investigation of an Investigational Medication for Moderate to Severe Atopic Dermatitis (a skin condition causing red, itchy, and inflamed skin)

Recruiting
12 years or above
All
Phase 3
420 participants needed
33 Locations

Study Overview

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).

Eligibility Criteria

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

  • Conditions: Dermatitis Atopic
  • Age: 12 years or above
  • 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 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.

Updated on 12 Dec 2024. Study ID: NCT06181435

The purpose of this study is to investigate the effects of an investigational medication compared to a placebo in treating moderate to severe atopic dermatitis (AD) in participants aged 12 years and older. Atopic dermatitis, also known as eczema, is a skin condition that causes red, itchy, and inflamed skin. The study aims to evaluate how well the treatment works and its safety for participants whose AD is not well managed with current topical treatments.

During the study, participants will be randomly assigned to one of three study arms. They will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve regular assessments to monitor the effects of the treatment and ensure participant safety.

  • Who can participate: Participants must be at least 12 years old and have had a diagnosis of atopic dermatitis for at least one year. They should have a history of inadequate response to topical or systemic treatments. Key eligibility criteria include a specific severity of AD and body weight of at least 25 kg.
  • Study details: Participants will be assigned to one of three study arms to receive either the investigational medication or a placebo. Participants will be monitored regularly to assess the effects of the treatment and ensure their safety.
  • Study Timelines and Visits: The study will last up to 44 weeks. The study requires up to 10 visits.

Pre-Screener

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Have you been diagnosed with atopic dermatitis (ecxema) for one year or longer?

Atopic dermatitis, often referred to as eczema, is a chronic skin condition characterized by red, itchy, and inflamed patches of skin. Symptoms can vary from person to person and can be triggered or worsened by factors like certain soaps, detergents, allergens, and changes in weather.


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