SAR444656 for Eczema
(ADVANTA Trial)

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sanofi

Disqualifiers: Psoriasis, Lupus, Immunosuppression, Malignancy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group Phase 2, 4-arm study in adult participants with moderate to severe AD who are inadequately controlled with topical therapies or for whom such topical therapies are inadvisable and who are candidates for systemic therapy. Participants will be randomized to receive SAR444656 dose 1, dose 2, dose 3 or matching placebo. Participants who meet inclusion/exclusion criteria will be stratified for randomization by severity of AD (moderate \[baseline EASI score \<22\] versus severe \[baseline EASI score ≥22\]). The total duration of study is approximately 24 weeks, including 1 to 4 weeks for screening, 16 weeks for double-blind study treatment and 4 weeks for follow-up.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain therapies are prohibited within a specific timeframe before the baseline visit, so it's best to discuss your current medications with the trial team.

Research Team

Eligibility Criteria

Adults with moderate to severe atopic dermatitis (AD), who haven't responded well to topical treatments or can't use them, are eligible for this trial. They must have had AD for at least a year, an EASI score of 12 or more, and AD covering 10% of their body. Participants need to commit to using daily moisturizers and completing an electronic diary throughout the study.

Inclusion Criteria

Topical medications haven't worked for me or are not advised.

My skin condition affects more than 10% of my body.

I have used a daily moisturizer for at least the last 7 days and will continue to do so.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 to 4 weeks

Treatment

Participants receive SAR444656 dose 1, dose 2, dose 3, or matching placebo for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

SAR444656 (Monoclonal Antibodies)

Trial OverviewThe trial is testing two different doses of SAR444656 against a placebo in adults with AD. It's designed as a double-blind study where neither participants nor researchers know who gets the actual drug versus placebo. The treatment lasts 16 weeks followed by a follow-up period, with patients grouped based on their severity of AD.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR444656 dose 3Experimental Treatment1 Intervention

Participants will receive SAR444656 dose 3 orally

Group II: SAR444656 dose 2Experimental Treatment1 Intervention

Participants will receive SAR444656 dose 2 orally

Group III: SAR444656 dose 1Experimental Treatment1 Intervention

Participants will receive SAR444656 dose 1 orally

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally