Amlitelimab for Eczema

(ATLANTIS Trial)

Recruiting at 342 trial locations

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

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Live vaccines

Disqualifiers: Immunosuppression, Malignancies, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 26

Duration: 160 weeks

901 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the long-term safety and effectiveness of a new treatment called amlitelimab for individuals with moderate to severe eczema, a skin condition causing itchy, inflamed patches. Participants will receive amlitelimab through under-the-skin injections for nearly five years. The trial seeks individuals aged 12 and up who have had eczema for at least one year and have not found success with other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer based on your specific situation.

Is there any evidence suggesting that amlitelimab is likely to be safe for humans?

Research has shown that amlitelimab is generally well-tolerated. In studies, most participants did not experience serious side effects. One study found the treatment safe, with no unexpected or severe issues. Another study noted improvements in atopic dermatitis (a skin condition causing itchy, inflamed skin) without major safety concerns. These findings suggest amlitelimab is safe for many, but consulting a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

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

Amlitelimab is unique because it targets a specific part of the immune system called OX40L, which plays a role in the inflammation seen in eczema. Unlike traditional treatments like topical steroids or immunosuppressants that can have broad effects, Amlitelimab's targeted action may result in fewer side effects and improved safety. Researchers are excited about this treatment because it offers a new approach to managing eczema, potentially providing relief for patients who do not respond well to existing therapies.

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

Research has shown that amlitelimab, the investigational treatment in this trial, offers promising results for treating moderate to severe eczema. A recent study found that amlitelimab significantly reduced eczema symptoms and was well tolerated by patients over a year. Many patients experienced a 50% to 90% decrease in their eczema symptoms. These improvements suggest amlitelimab could effectively treat those with atopic dermatitis. ^{1 4 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults with moderate to severe atopic dermatitis (AD) who haven't responded well to topical treatments can join this study. They must have had AD for over a year, an Eczema Area Severity Index score of 16+, and cover at least 10% of their body. Pregnant or breastfeeding women are excluded, as are those with certain infections like TB, HIV, hepatitis B/C, or recent vaccinations.

Inclusion Criteria

You have severe itching, with a weekly average rating of 4 or higher on a scale from 0 to 10.

Topical treatments haven't worked for me in the last 6 months.

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Exclusion Criteria

I have a history of serious immune system problems or frequent, long-lasting infections.

You have tested positive for HIV, hepatitis B, or hepatitis C.

I do not have active or latent TB, nor have I been in close contact with TB patients recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous amlitelimab for long-term safety and efficacy evaluation

160 weeks

26 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview The trial is testing Amlitelimab's long-term safety and effectiveness in adults with moderate to severe AD. Participants will be observed for approximately three years during which they'll receive the drug and attend 26 scheduled visits including follow-ups after treatment ends.

How Is the Trial Designed?

Group I: Amlitelimab Experimental Treatment 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

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 ... Sanofi's amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic ...

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. fiercebiotech.com fiercebiotech.com/biotech/rash-selling-sanofi-shares-slump-phase-3-eczema-win-fails-soothe-market-fears

Sanofi phase 3 eczema win falls short of analyst expectations A phase 3 trial of Sanofi's eczema prospect amlitelimab has hit its primary and key secondary endpoints. Yet, with the data falling short of ...

6. jaad.org jaad.org/article/S0190-9622(22)01573-0/fulltext

34312 Treatment with amlitelimab (KY1005, SAR445229) Results: Of 59 subjects who received amlitelimab, 44 were evaluable at W16. Amlitelimab was well tolerated with unremarkable safety profile. Mean % change ...

7. 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.

8. academic.oup.com academic.oup.com/bjd/article/189/5/531/7226167

Safety and efficacy of amlitelimab, a fully human nondepleting ... This phase IIa double-blind placebo-controlled study assessed the safety and efficacy of amlitelimab over 16 weeks in adults with atopic dermatitis (AD). A.