Amlitelimab for Atopic Dermatitis (COAST 1)

(COAST 1 Trial)

Recruiting at 79 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Disqualifiers: Immunosuppression, Malignancies, Active infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called amlitelimab for individuals with moderate to severe eczema (atopic dermatitis). It includes three groups: two will receive different doses of amlitelimab injections, and one will receive a placebo, which resembles the treatment but contains no active ingredient. Individuals who have had eczema for at least a year and find creams or pills ineffective or unsuitable may qualify for this study. Participants will attend regular visits for up to 44 weeks unless they opt to join an extension study. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to help bring a new treatment closer to availability.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amlitelimab is generally safe for people with moderate to severe atopic dermatitis, a type of eczema. Previous studies found that this treatment did not cause many serious side effects. In one study, amlitelimab improved eczema symptoms without major safety concerns. Another study confirmed that the treatment had no major safety issues. Overall, these findings suggest that amlitelimab is safe for people with eczema. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard treatments for atopic dermatitis, which often involve topical corticosteroids and calcineurin inhibitors, Amlitelimab offers a novel approach. Researchers are excited about Amlitelimab because it targets the OX40-Ligand, a key player in the immune response associated with eczema. By focusing on this specific mechanism, Amlitelimab has the potential to reduce inflammation and improve skin symptoms more effectively. Additionally, its subcutaneous delivery method may offer greater convenience and adherence compared to some current therapies.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Studies have shown that amlitelimab could be a promising treatment for atopic dermatitis, also known as eczema. In earlier research, amlitelimab greatly reduced symptoms and improved skin condition in adults with eczema. Patients experienced a significant decrease in symptom severity over time. The treatment also positively affected key markers of disease activity. Overall, amlitelimab was well tolerated, with most patients not experiencing serious side effects during the studies. Participants in this trial will receive either one of two doses of amlitelimab or a placebo to further evaluate its effectiveness and safety. ^{1 3 4 6 7}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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?

Does your atopic dermatitis cover a significant portion of your body?

Exclusion Criteria

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

In the past year, have you taken any of the following medications: Abrocitinib (brand name Cibinqo), Upadacitinib (brand name Rinvoq), or Baricitinib (brand name Olumiant)?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amlitelimab or placebo via subcutaneous injection in a randomized, double-blind manner

24 weeks

Up to 10 visits (or 9 visits for those entering the extension study)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Blinded Extension (optional)

Participants may opt into a separate blinded extension study (EFC17600) for continued treatment

Up to 28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview 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.

How Is the Trial Designed?

Group I: Amlitelimab dose 2 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1 Experimental Treatment 1 Intervention

Subcutaneous injection as per protocol

Group III: Placebo Placebo Group 1 Intervention

Subcutaneous injection as per protocol

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Abrocitinib, a JAK1-selective inhibitor, has been shown to have a manageable long-term safety profile for treating moderate-to-severe atopic dermatitis, based on an analysis of 2856 patients over 1614 patient-years.

While some dose-related adverse events like nausea and headache were observed, serious infections and other severe complications were relatively low, indicating that with proper patient selection, abrocitinib can be safely used for extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Simpson, EL., Silverberg, JI., Nosbaum, A., et al.[2022]

Ruxolitinib 1.5% cream is the first FDA-approved topical JAK inhibitor for atopic dermatitis (AD), showing high efficacy in treating this chronic skin condition.

The cream has a favorable safety profile, making it a promising new option for patients suffering from the pruritic and inflammatory symptoms of AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. Owji, S., Caldas, SA., Ungar, B.[2022]

In a phase 3 clinical trial involving 285 adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis, oral abrocitinib combined with topical therapy significantly improved skin condition compared to placebo, with 46.2% and 41.6% of patients achieving clear or almost clear skin (IGA response) at the 200 mg and 100 mg doses, respectively.

The treatment also led to a 75% or greater improvement in eczema severity (EASI-75) in 72.0% and 68.5% of patients at the higher doses, while maintaining an acceptable safety profile, with nausea being the most common adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. Eichenfield, LF., Flohr, C., Sidbury, R., et al.[2022]

Ruxolitinib cream showed effective long-term disease control in atopic dermatitis, with 74.1% to 77.8% of patients achieving low disease severity scores after 52 weeks of treatment.

The cream was well-tolerated, with most adverse events being mild and unrelated to the treatment, suggesting a favorable safety profile and minimal systemic absorption of the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. Papp, K., Szepietowski, JC., Kircik, L., et al.[2023]

In three phase 3 studies involving adolescents aged 12-17 with moderate-to-severe atopic dermatitis, abrocitinib significantly improved clinical signs compared to placebo, with over 83% of patients achieving meaningful improvements in eczema severity and quality of life measures after 12 weeks.

Abrocitinib treatment also led to significant reductions in sleep loss and enhanced overall quality of life, demonstrating its efficacy as both monotherapy and in combination with topical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of oral abrocitinib on signs, symptoms and quality of life among adolescents with moderate-to-severe atopic dermatitis: an analysis of patient-reported outcomes. Cork, MJ., McMichael, A., Teng, J., et al.[2022]

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170

Press Release: Sanofi's amlitelimab met all primary and ... “Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39522654/

Phase 2b randomized clinical trial of amlitelimab, an anti- ... Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52.

3. jacionline.org jacionline.org/article/S0091-6749(24)01175-8/fulltext

Phase 2b randomized clinical trial of amlitelimab, an anti ... For other secondary efficacy outcomes, greater proportions of patients achieved a 50% reduction in EASI and 90% reduction in EASI and greater ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03754309

NCT03754309 | A Study of KY1005 in Patients With ... The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0091674924011758

Phase 2b randomized clinical trial of amlitelimab, an anti- ... Amlitelimab treatment significantly reduced clinical and biomarker responses, and was well tolerated in adults with AD through week 52.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37463508/

Safety and efficacy of amlitelimab, a fully human ... Novel targeting of OX40L-expressing APCs with amlitelimab was well tolerated and resulted in clinically meaningful improvements in AD.

7. jaad.org jaad.org/article/S0190-9622(23)02242-9/fulltext

41343 Safety of Amlitelimab in a Phase 2a Clinical Trial ... Amlitelimab was well tolerated in a Phase 2a trial of patients with moderate-to-severe atopic dermatitis, confirming the unremarkable safety profile observed ...