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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 up to week 20

Awards & highlights

ZEN Trial 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.Check my eligibility

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.See study design

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.

ZEN Trial 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.

ZEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 20 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 total abscess and inflammatory nodule (AN) count

Secondary outcome measures

Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)

Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)

Change from baseline in the amount of analgesic

+7 more

ZEN Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR444656Experimental Treatment1 Intervention

Participants will receive SAR444656 orally

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kymera Therapeutics, Inc.Industry Sponsor

6 Previous Clinical Trials

579 Total Patients Enrolled

2 Trials studying Hidradenitis Suppurativa

194 Patients Enrolled for Hidradenitis Suppurativa

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,881 Total Patients Enrolled

2 Trials studying Hidradenitis Suppurativa

198 Patients Enrolled for Hidradenitis Suppurativa

Frequently Asked Questions

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

Is this research project open to those of senior age?

"The requirements for participation in this trial specify that potential participants should have an age between 18 and 70. There are 3 additional studies available to those under the age of 18, as well as 34 trials targeting elderly individuals above 65 years old."

Answered by AI

Are there widespread locations within the U.S. administering this research?

"At this time, the trial is recruiting patients from 4 distinct locations - Hollywood, Weston, Indianapolis and an additional four sites. To reduce travel obligations as a participant in the study it may be best to select the nearest clinic."

Answered by AI

What is the enrollment quota for this research study?

"Affirmative. The study, which was first included on September 29th 2023, is currently recruiting participants across 4 sites and requires a total of 99 subjects."

Answered by AI

Are there any unfilled vacancies for participants in this research project?

"Presently, this trial is actively enrolling participants. Clinicaltrials.gov clarifies that the study was originally posted on September 29th 2023 and has been updated most recently on December 5th 2023."

Answered by AI

Would I qualify to join this medical research endeavor?

"This trial seeks to enrol 99 participants, aged 18-70 years old, who have been affected by hidradenitis suppurativa for at least one year. To be eligible, the patient must possess a total AN count of ≥5 and CRP >3 mg/L as well as ≤20 draining tunnels. Furthermore, they should have had an inadequate response to oral antibiotic treatments with 3 or more months of usage under their belt. Lastly, both genders are expected to comply with local regulations regarding contraceptive use if applicable."

Answered by AI

Has SAR444656 been granted authorization by the Food and Drug Administration?

"Our team at Power has assessed SAR444656's safety to be a 2 on the 1-3 scale. This is because it is currently undergoing Phase 2 trials, which indicates there are some data validating its safety but none for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

2023. "A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028230.

All > Hidradenitis Suppurativa