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Monoclonal Antibodies

SAR444656 dose 2 for Atopic Dermatitis (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 0, week 1, week 2, week 4, and week 16

Awards & highlights

ADVANTA Trial 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.Check my eligibility

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.See study design

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.

ADVANTA Trial 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.

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I experience moderate to severe pain regularly.

ADVANTA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 1, week 2, week 4, and week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 1, week 2, week 4, and week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 1, week 2, week 4, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline in EASI

Secondary outcome measures

Absolute change from baseline in EASI

Absolute change from baseline in weekly average of daily PP-NRS

Change from baseline in percent body surface area (BSA) affected by AD

+8 more

ADVANTA Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR444656 dose 2Experimental Treatment1 Intervention

Participants will receive SAR444656 dose 2 orally

Group II: SAR444656 dose 1Experimental Treatment1 Intervention

Participants will receive SAR444656 dose 1 orally

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,865 Total Patients Enrolled

Kymera Therapeutics, Inc.Industry Sponsor

6 Previous Clinical Trials

563 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this research project?

"Affirmative. The clinicaltrials.gov website states that this trial is currently searching for participants, with the initial posting occuring on November 9th 2023 and last updated on December 5th 2023. A total of 115 individuals need to be enrolled from 2 specific locations."

Answered by AI

Has the FDA approved SAR444656 dose 2 for use?

"SAR444656 dose 2 received a rating of 2 on Power's safety scale due to the lack of efficacy data, but some assurance from Phase 2 trial results."

Answered by AI

Are there still open slots available for those interested in participating in this trial?

"Affirmative, according to the information on clinicaltrials.gov this study is presently recruiting participants. It was first published on November 9th 2023 and then revised most recently on December 5th 2023. 115 people are needed at 2 medical sites for this trial."

Answered by AI