Amlitelimab for Atopic Dermatitis (COAST 1)

(COAST 1 Trial)

Recruiting at 95 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

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: 10

Duration: 24 weeks

420 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an injectable treatment called amlitelimab for people aged 12 and older with moderate to severe eczema that doesn't respond well to creams or ointments. The treatment aims to reduce skin inflammation and itching by blocking specific proteins in the immune system. The study will evaluate how effective and safe amlitelimab is.

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.

How is the drug Amlitelimab different from other treatments for atopic dermatitis?

Amlitelimab is unique because it is administered as a subcutaneous (under the skin) injection, which may offer a different approach compared to other treatments like topical creams or oral medications. This method of delivery can provide a more targeted treatment option for atopic dermatitis. ^{1 2 3 4 5}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies. [2023]

2. United States 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. [2022]

3. New Zealand 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. [2022]

4. England 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. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. [2022]