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Monoclonal Antibodies

SAR444656 for Hidradenitis Suppurativa (ZEN 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
Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III.
Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16

Summary

This trial will assess the effects of a new drug on adults with severe acne over a 24-week period. 14 visits will be required.

Who is the study for?
Adults aged 18-70 with moderate to severe Hidradenitis Suppurativa (HS), having lesions in at least two areas and one area being Hurley Stage II or III. They must have had HS for over a year, not responded well to antibiotics for HS, have an active lesion count of 5 or more, fewer than 20 draining tunnels, and elevated CRP levels indicating inflammation.
What is being tested?
The trial is testing SAR444656 against a placebo in adults with HS. Participants will be randomly assigned to receive either the drug or placebo during a treatment period of up to 16 weeks, followed by follow-up visits totaling up to 24 weeks duration.
What are the potential side effects?
While specific side effects are not listed here, typical clinical trial risks may include allergic reactions, injection site discomfort, potential unknown long-term effects of the new medication SAR444656 compared to no expected benefits from the inactive placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have HS lesions in at least 2 different areas, with one area being moderate or severe.
Select...
I have had symptoms of HS for at least a year.

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 total abscess and inflammatory nodule (AN) count

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

Find a Location

Who is running the clinical trial?

Kymera Therapeutics, Inc.Industry Sponsor
7 Previous Clinical Trials
711 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
194 Patients Enrolled for Hidradenitis Suppurativa
SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,976 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
176 Patients Enrolled for Hidradenitis Suppurativa
~83 spots leftby Jun 2026
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