Amlitelimab for Eczema
(ATLANTIS Trial)

Recruiting in Palo Alto (17 mi)

+257 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Must not be taking: Live vaccines

Disqualifiers: Immunosuppression, Malignancies, Transplant, others

No Placebo Group

Prior Safety Data

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.

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.

+6 more

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.

+12 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: AmlitelimabExperimental Treatment1 Intervention

Subcutaneous injection as per protocol