Amlitelimab for Eczema

(RIVER-AD Trial)

Recruiting at 277 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

1551 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing amlitelimab, a medication for adults with moderate to severe atopic dermatitis who were in a previous trial. The study aims to see if the medication is safe and effective over an extended time. Amlitelimab works by calming the immune system to reduce skin inflammation.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Amlitelimab Experimental Treatment 4 Interventions

Subcutaneous injection

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