Amlitelimab for Eczema

(ATLANTIS 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

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

Trial Summary

What is the purpose of this trial?

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 160 weeks (approximately 3 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.

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.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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.

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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