What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, such as monoclonal antibodies and systemic therapies, have a range of side effects. Dupilumab, an anti-IL-4Rα monoclonal antibody, can cause injection site reactions, conjunctivitis, and eosinophilia. JAK inhibitors, another class of systemic treatments, may lead to nasopharyngitis, headache, and increased risk of infections. Other biologics like tralokinumab and abrocitinib have similar side effects, including injection site reactions and potential for increased infection risk. Overall, while these treatments can be effective, they require monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, particularly focusing on monoclonal antibodies and systemic therapies. Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, has shown long-term effectiveness in treating moderate-to-severe atopic dermatitis. Other systemic treatments include cyclosporine and methotrexate, which have been used for severe cases. While specific information on Amlitelimab, which targets the OX40-Ligand, is not available, these treatments represent the current landscape of FDA-approved therapies for atopic dermatitis.

What other types of research exist?

Promising novel alternatives to Amlitelimab for Atopic Dermatitis patients include Dupilumab (anti-IL-4Rα), which has shown efficacy in both AD and alopecia areata, and Omalizumab, which has been effective in eosinophilic dermatosis and may offer benefits for AD. Additionally, emerging therapies targeting IL-13, such as Tralokinumab and Lebrikizumab, are also promising options.

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Monoclonal Antibodies

Amlitelimab for Atopic Dermatitis (COAST 2)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have you had atopic dermatitis for at least 1 year?

In the past six months, have you had a poor response to any of the treatments you took for your atopic dermatitis?

Must not have

Have you experienced suicidal ideation or thoughts of self-harm in the past 6 months?

Have you been diagnosed with any of the following: psoriasis, tinea corporis, or lupus erythematosus?

Timeline

Screening 2 weeks

Treatment 24 weeks

Follow Up 16 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests amlitelimab injections for patients aged 12 and older with moderate to severe atopic dermatitis that isn't controlled by topical treatments. The injections aim to reduce inflammation and symptoms by targeting specific immune pathways.

Who is the study for?

You are eligible if you have been diagnosed with moderate-to-severe AD for a year or longer and used topical corticosteroids or topical calcineurin inhibitors without adequate benefit from topical medications within the last 6 months or used systemic therapies for AD without adequate benefit within the last 12 months.

What is being tested?

Atopic dermatitis is an immune system condition. The investigational drug, amlitelimab, is an immunotherapy that targets the inflammation cascade. It is aimed to calm the immune system to prevent inflammation. Amlitelimab has been shown to be well tolerated by patients in previous clinical studies but is not yet approved for treating atopic dermatitis.

What are the potential side effects?

The most frequently reported side effects in participants who received amlitelimab (reported in ≥ 5% of study participants) and more frequent compared to those who received placebo (a ≥1% difference between amlitelimab compared to placebo) were: nasopharyngitis, COVID-19, and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 weeks1 visit

Treatment ~ 24 weeks8 visits

Follow Up ~ 16 weeks1 visit

Screening ~ 2 weeks

Treatment ~ 24 weeks

Follow Up ~16 weeks

This trial's timeline: 2 weeks for screening, 24 weeks for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

Secondary study objectives

Absolute change in SCORAD index from baseline

Absolute change in weekly average of daily PP-NRS from baseline

Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline

+29 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose 2Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group III: PlaceboPlacebo Group1 Intervention

Subcutaneous injection as per protocol

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atopic Dermatitis (AD) include monoclonal antibodies and systemic therapies that target specific immune pathways to reduce inflammation and pruritus. Amlitelimab, for example, targets the OX40-Ligand, which is involved in T-cell activation and survival, thereby reducing the inflammatory response. Other monoclonal antibodies like Dupilumab target the IL-4 and IL-13 pathways, crucial in AD's inflammatory process. Systemic therapies such as JAK inhibitors and immunosuppressants like cyclosporine broadly suppress immune activity to reduce inflammation. Understanding these mechanisms helps in selecting the most appropriate treatment, potentially leading to better symptom management and improved quality of life for AD patients.