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

NCT06028230 | Terminated Phase 2 DMC FDA Drug

• 3 other identifiers: ACT178412023-504328-25U1111-1285-8790
• Study Type: interventional
• Target: 70
• Locations: 8 countries
• Sites: 52

Brief Summary

This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years. 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

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in total abscess and inflammatory nodule (AN) count

  The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts obtained as part of the HS clinical parameters.

  Week 16

Secondary Outcomes (10)

• Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)

  Week 16

• Proportion of participants achieving AN count ≤2

  Week 16

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

  Week 16

• Proportion of participants with improvement from baseline in Hurley Stage

  Week 16

• Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)

  Week 16

Study Arms (3)

SAR444656 dose 1

EXPERIMENTAL

Participants will receive SAR444656 dose 1 orally

Drug: SAR444656 (KT-474)

SAR444656 dose 2

EXPERIMENTAL

Participants will receive SAR444656 dose 2 orally

Drug: SAR444656 (KT-474)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally

Drug: Placebo

Interventions

SAR444656 (KT-474) DRUG

Oral Tablet

SAR444656 dose 1; SAR444656 dose 2

Placebo DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
• 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.

You may not qualify if:

• Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
• 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:

Sponsors & Collaborators

• Sanofi: lead
• Kymera Therapeutics, Inc.: collaborator

Study Sites (52)

Clear Dermatology & Aesthetics Center- Site Number : 8400006

Scottsdale, Arizona, 85255, United States

Location

Cosmetic Dermatology of Orange County- Site Number : 8400024

Anaheim, California, 92807, United States

Location

First OC Dermatology - Fountain Valley- Site Number : 8400007

Fountain Valley, California, 92708-3701, United States

Location

Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021

San Diego, California, 92108, United States

Location

Clinical Trials Management Services - Thousand Oaks- Site Number : 8400028

Thousand Oaks, California, 91360, United States

Location

Advanced Dermatology and Cosmetic Care- Site Number : 8400025

Valencia, California, 91355, United States

Location

Encore Medical Research of Boynton Beach- Site Number : 8400002

Boynton Beach, Florida, 33436, United States

Location

Moore Clinical Research - Brandon- Site Number : 8400001

Brandon, Florida, 33511, United States

Location

Encore Medical Research - 6600 Taft St- Site Number : 8400005

Hollywood, Florida, 33024, United States

Location

Sullivan Dermatology- Site Number : 8400003

Miami, Florida, 33162, United States

Location

ARA Professionals- Site Number : 8400023

Miami, Florida, 33176-1032, United States

Location

Encore Medical Research - Weston- Site Number : 8400010

Weston, Florida, 33331, United States

Location

Dermatology Specialists Research (DS Research) - Indiana- Site Number : 8400012

Clarksville, Indiana, 47129, United States

Location

Dawes Fretzin Clinical Research- Site Number : 8400011

Indianapolis, Indiana, 46256, United States

Location

Beth Israel Deaconess Medical Center - 110 Francis St- Site Number : 8400013

Boston, Massachusetts, 02215-5563, United States

Location

Wayne Health - Dearborn- Site Number : 8400004

Dearborn, Michigan, 48124-4085, United States

Location

Revive Research Institute-1575 W Big Beaver Rd- Site Number : 8400008

Troy, Michigan, 48084-3536, United States

Location

Vial Health - DermDox Dermatology- Site Number : 8400020

Camp Hill, Pennsylvania, 17011, United States

Location

Clinical Research Philadelphia,LLC- Site Number : 8400026

Philadelphia, Pennsylvania, 19114-1025, United States

Location

UPMC Montefiore- Site Number : 8400009

Pittsburgh, Pennsylvania, 15213, United States

Location

Dermatology Specialists of Spokane- Site Number : 8400015

Spokane, Washington, 99202-1332, United States

Location

Investigational Site Number : 1240004

Québec, Quebec, G1W 4R4, Canada

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520003

Independencia, 8380000, Chile

Location

Investigational Site Number : 1520001

Las Condes, 7580206, Chile

Location

Investigational Site Number : 1520004

Temuco, 4810345, Chile

Location

Investigational Site Number : 2760002

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Investigational Site Number : 2760008

Munich, Bavaria, 80337, Germany

Location

Investigational Site Number : 2760006

Würzburg, Bavaria, 97080, Germany

Location

Investigational Site Number : 2760007

Frankfurt am Main, Hesse, 60590, Germany

Location

Investigational Site Number : 2760001

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Investigational Site Number : 2760004

Remscheid, North Rhine-Westphalia, 42897, Germany

Location

Investigational Site Number : 2760009

Dessau, Saxony-Anhalt, 06847, Germany

Location

Investigational Site Number : 2760005

Berlin, 10789, Germany

Location

Investigational Site Number : 3000003

Athens, Attica, 12462, Greece

Location

Investigational Site Number : 3000001

Pavlos Melas, Thessaloniki, 564 29, Greece

Location

Investigational Site Number : 3000002

Thessaloniki, 546 43, Greece

Location

Investigational Site Number : 6160006

Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

Location

Investigational Site Number : 6160002

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Investigational Site Number : 6160005

Lodz, Lódzkie, 90-436, Poland

Location

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Investigational Site Number : 6160007

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Investigational Site Number : 6160004

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Investigational Site Number : 4100002

Cheonan-si, Chungcheongnam-do, 330721, South Korea

Location

Investigational Site Number : 4100001

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Investigational Site Number : 4100003

Seongbuk-Gu, Seoul-teukbyeolsi, 02841, South Korea

Location

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 7240004

Cadiz, Cádiz, 11009, Spain

Location

Investigational Site Number : 7240005

Manises, Valencia, 46940, Spain

Location

Investigational Site Number : 7240003

Alicante, 03010, Spain

Location

Investigational Site Number : 7240001

Granada, 18014, Spain

Location

Investigational Site Number : 7240002

Seville, 41009, Spain

Location

Related Links

• ACT17841 Plain Language Results Summary

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 29, 2023
• Primary Completion: October 9, 2025
• Study Completion: November 12, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (4); CA (1); PL (6); US (21); CL (4); ES (5); DE (8); GR (3)