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Monoclonal Antibodies

SAR444656 for Eczema (ADVANTA Trial)

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AD involvement ≥10% of BSA at screening and baseline visit
Baseline PP-NRS ≥4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16

Summary

This trial will examine a drug for treating moderate to severe adult eczema not responding to topical treatments. Participants will be randomly assigned to receive one of two doses or a placebo for 16 weeks, followed by 4 weeks of follow-up.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with clinical trials for new medications treating skin conditions like AD may include skin irritation or redness, itching, infection risk increase due to immune system changes, headaches and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin condition affects more than 10% of my body.
Select...
I experience moderate to severe pain regularly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change from baseline in EASI

Trial Design

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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,199 Previous Clinical Trials
4,036,087 Total Patients Enrolled
Kymera Therapeutics, Inc.Industry Sponsor
7 Previous Clinical Trials
740 Total Patients Enrolled
~125 spots leftby Jul 2026
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