A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06028230
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-09-29
2026-07-17
Brief Summary
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Study details include:
* Screening period: up to 4 weeks (30 days)
* Treatment duration: up to 16 weeks
* Follow-up period: up to 4 weeks
* Total study duration: up to 24 weeks
* Number of visits: 14
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR444656 dose 1
Participants will receive SAR444656 dose 1 orally
SAR444656 (KT-474)
Oral Tablet
SAR444656 dose 2
Participants will receive SAR444656 dose 2 orally
SAR444656 (KT-474)
Oral Tablet
Placebo
Participants will receive placebo orally
Placebo
Oral Tablet
Interventions
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SAR444656 (KT-474)
Oral Tablet
Placebo
Oral Tablet
Eligibility Criteria
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Inclusion Criteria
* 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 must have had an inadequate response after at least one-month of oral antibiotic treatment for HS, as assessed by the Investigator.
* Participant must have a total AN count of ≥5 at the baseline visit.
* Participant must have a draining tunnel count of ≤20 at the baseline visit.
* Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.
* Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
* Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
* Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Participant with history of solid organ transplant.
* Participant with history of splenectomy.
* Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
* Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS
* Participant with family history of sudden death or long QT syndrome.
* Participant with history of congenital or drug-induced long QT syndrome.
* Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
* Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
* Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
* Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication.
* Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
* Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions:
* Discontinued due to treatment related toxicity and/or
* Discontinuation is not related to lack or loss of therapeutic response.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Kymera Therapeutics, Inc.
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Locations
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Clear Dermatology & Aesthetics Center- Site Number : 8400006
Scottsdale, Arizona, United States
Cosmetic Dermatology of Orange County- Site Number : 8400024
Anaheim, California, United States
First OC Dermatology - Fountain Valley- Site Number : 8400007
Fountain Valley, California, United States
Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021
San Diego, California, United States
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400028
Thousand Oaks, California, United States
Advanced Dermatology and Cosmetic Care- Site Number : 8400025
Valencia, California, United States
Encore Medical Research of Boynton Beach- Site Number : 8400002
Boynton Beach, Florida, United States
Moore Clinical Research - Brandon- Site Number : 8400001
Brandon, Florida, United States
Encore Medical Research - 6600 Taft St- Site Number : 8400005
Hollywood, Florida, United States
Sullivan Dermatology- Site Number : 8400003
Miami, Florida, United States
ARA Professionals- Site Number : 8400023
Miami, Florida, United States
Encore Medical Research - Weston- Site Number : 8400010
Weston, Florida, United States
Dermatology Specialists Research (DS Research) - Indiana- Site Number : 8400012
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research- Site Number : 8400011
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center - 110 Francis St- Site Number : 8400013
Boston, Massachusetts, United States
Wayne Health - Dearborn- Site Number : 8400004
Dearborn, Michigan, United States
Revive Research Institute-1575 W Big Beaver Rd- Site Number : 8400008
Troy, Michigan, United States
Vial Health - DermDox Dermatology- Site Number : 8400020
Camp Hill, Pennsylvania, United States
Clinical Research Philadelphia,LLC- Site Number : 8400026
Philadelphia, Pennsylvania, United States
UPMC Montefiore- Site Number : 8400009
Pittsburgh, Pennsylvania, United States
Dermatology Specialists of Spokane- Site Number : 8400015
Spokane, Washington, United States
Investigational Site Number : 1240004
Québec, Quebec, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Independencia, , Chile
Investigational Site Number : 1520001
Las Condes, , Chile
Investigational Site Number : 1520004
Temuco, , Chile
Investigational Site Number : 2760002
Heidelberg, Baden-Wurttemberg, Germany
Investigational Site Number : 2760008
Munich, Bavaria, Germany
Investigational Site Number : 2760006
Würzburg, Bavaria, Germany
Investigational Site Number : 2760007
Frankfurt am Main, Hesse, Germany
Investigational Site Number : 2760001
Bochum, North Rhine-Westphalia, Germany
Investigational Site Number : 2760004
Remscheid, North Rhine-Westphalia, Germany
Investigational Site Number : 2760009
Dessau, Saxony-Anhalt, Germany
Investigational Site Number : 2760005
Berlin, , Germany
Investigational Site Number : 3000003
Athens, Attica, Greece
Investigational Site Number : 3000001
Pavlos Melas, Thessaloniki, Greece
Investigational Site Number : 3000002
Thessaloniki, , Greece
Investigational Site Number : 6160006
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160002
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160005
Lodz, Lódzkie, Poland
Investigational Site Number : 6160003
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160007
Katowice, Silesian Voivodeship, Poland
Investigational Site Number : 6160004
Ossy, Silesian Voivodeship, Poland
Investigational Site Number : 4100002
Cheonan-si, Chungcheongnam-do, South Korea
Investigational Site Number : 4100001
Seongnam-si, Gyeonggi-do, South Korea
Investigational Site Number : 4100003
Seongbuk-Gu, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240004
Cadiz, Cádiz, Spain
Investigational Site Number : 7240005
Manises, Valencia, Spain
Investigational Site Number : 7240003
Alicante, , Spain
Investigational Site Number : 7240001
Granada, , Spain
Investigational Site Number : 7240002
Seville, , Spain
Countries
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Related Links
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ACT17841 Plain Language Results Summary
Other Identifiers
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2023-504328-25
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1285-8790
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT17841
Identifier Type: -
Identifier Source: org_study_id