Amlitelimab for Atopic Dermatitis (SHORE)

(SHORE Trial)

Recruiting at 150 trial locations

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

Age: Any Age

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Sanofi

Must be taking: Topical corticosteroids, Topical calcineurin

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

643 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of amlitelimab, administered as an injection, for treating moderate to severe eczema, also known as atopic dermatitis. Researchers seek to determine if amlitelimab is safe and more effective than a placebo (a non-active treatment) for individuals who haven't found success with their usual creams or ointments. The trial seeks participants who have had eczema for at least a year, with large areas of skin affected and recent difficulty finding relief from topical treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment option.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have a history of inadequate response to topical treatments. It seems you may need to continue using topical corticosteroids or calcineurin inhibitors during the trial.

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

Research shows that amlitelimab is generally well tolerated. Studies indicate it helps people with moderate-to-severe atopic dermatitis, a type of eczema, feel better. One study found that patients experienced few side effects, typical for this kind of treatment. Another study confirmed that amlitelimab is safe, as it didn’t cause any unexpected issues. While these results are encouraging, ongoing research continues to ensure the treatment is safe and effective for everyone who uses it. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Amlitelimab is unique because it offers a novel approach for treating eczema by targeting the OX40-Ligand, which plays a role in the immune response associated with inflammation. Unlike traditional treatments like topical steroids and calcineurin inhibitors that mainly focus on reducing symptoms, Amlitelimab aims to address the underlying immune pathways that contribute to eczema. Researchers are excited about this treatment because it has the potential to provide longer-lasting relief with fewer side effects, offering a new hope for patients with chronic eczema.

What evidence suggests that amlitelimab could be an effective treatment for eczema?

Research shows that amlitelimab, which participants in this trial may receive, has promising results for treating moderate-to-severe eczema (also known as atopic dermatitis). In earlier studies, patients who received amlitelimab experienced significant improvements in their skin, with fewer symptoms and lower levels of disease markers. Many patients saw a substantial drop in their Eczema Area and Severity Index (EASI), with some achieving up to a 90% reduction. The treatment was generally well tolerated, as most people did not experience serious side effects. These findings suggest that amlitelimab could be a strong option for those dealing with eczema. ^{1 3 4 6 7}

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 last six months, have you had a poor response to any topical medications?

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?

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 for 24 weeks

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 (ESTUARY)

Up to 28 weeks including screening and treatment

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab
• Placebo
• Topical calcineurin inhibitors
• Topical corticosteroids

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 3 Interventions

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1 Experimental Treatment 3 Interventions

Subcutaneous injection as per protocol

Group III: Placebo Placebo Group 3 Interventions

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

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. 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 ...

4. 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 ...

5. jaad.org jaad.org/article/S0190-9622(24)01111-3/fulltext

53907 Amlitelimab improves extent and severity of disease ... Amlitelimab has previously demonstrated 24-week primary endpoint efficacy in adults with moderate-to-severe AD. Methods: STREAM-AD (NCT05131477) is a 52-week, ...

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 ...