Amlitelimab for Eczema

(RIVER-AD Trial)

Recruiting at 423 trial locations

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

Age: Any Age

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Sanofi

Disqualifiers: Immunosuppression, Transplant history, Malignancies, TB, 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: 4

Duration: 332 weeks

1663 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the drug amlitelimab for individuals with moderate to severe eczema (atopic dermatitis) who previously participated in an amlitelimab study. Participants will check in every four weeks to monitor progress. The study examines the duration of treatment effects and the outcomes of pausing and restarting treatment. Individuals who participated in earlier amlitelimab trials for eczema and completed the required assessments are well-suited for this trial. As a Phase 2, Phase 3 trial, it measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to advance eczema treatment.

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 investigators 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 safe for people with moderate to severe eczema. One study found amlitelimab safe, with no major safety issues for participants. Another study reported significant improvement in eczema symptoms without serious side effects. These findings suggest amlitelimab does not cause unexpected or severe problems. Overall, various studies have tested the treatment with positive safety results, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

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

Unlike the standard treatments for eczema, which often include topical steroids or immunosuppressants, Amlitelimab offers a novel approach by targeting the OX40L pathway. This pathway plays a crucial role in regulating immune responses, and by modulating it, Amlitelimab aims to reduce inflammation and itching with potentially fewer side effects. Researchers are excited about Amlitelimab because it is administered via subcutaneous injection, which could provide more consistent relief and convenience compared to daily topical applications.

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

Research has shown that amlitelimab, the investigational treatment in this trial, may help treat moderate to severe atopic dermatitis, also known as eczema. In one study, patients who took amlitelimab experienced a significant reduction in symptoms and signs of eczema over 52 weeks. Many patients saw their Eczema Area and Severity Index (EASI) scores decrease by 50% or even 90%. Another study found that patients showed strong improvement by week 16, indicating that amlitelimab can offer lasting relief. Overall, these findings suggest that amlitelimab could be an effective treatment option for eczema. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

Adults with moderate to severe atopic dermatitis who participated in a previous study (KY1005-CT05) and either didn't improve enough, lost response over time, or experienced worsening after the study can join. They must be able to follow the trial's procedures and have no new medical conditions that would make them ineligible.

Inclusion Criteria

Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their parent study SFY17915

Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:

Provide signed informed consent and able to comply with the requirements of the protocol

Exclusion Criteria

Participants with an intermediate or a positive IGRA test are excluded from the study unless all of the following conditions are met:

Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient's participation unreliable, or may interfere with study assessments

I have no cancer history, except for non-melanoma skin cancer cured over 5 years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous amlitelimab with visits every 4 weeks. Responder participants may undergo drug withdrawal to monitor treatment durability.

332 weeks

Visits every 4 weeks (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation for a minimum of 140 days.

20 weeks

Open-label extension

Long-term extension study to evaluate the long-term safety, tolerability, and efficacy of amlitelimab.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Amlitelimab

Trial Overview The safety and effectiveness of Amlitelimab are being tested in adults with moderate to severe atopic dermatitis over an extended period. Participants will receive regular treatments and assessments, sometimes through home visits if necessary.

How Is the Trial Designed?

Group I: Amlitelimab dose level 2 Experimental Treatment 4 Interventions

Subcutaneous injection as per protocol

Group II: Amlitelimab dose level 1 Experimental Treatment 4 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 ... 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. 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. jaad.org jaad.org/article/S0190-9622(22)01904-1/fulltext

33781 Sustained and durable response up to 24 weeks ... This Ph2a study has demonstrated that Amlitelimab monotherapy targeting APCs is not only associated with a marked clinical improvement at Week16 but in ...

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 ...