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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Oral Tablet
Oral Tablet
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.
Time frame: Week 16
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)
Time frame: Week 16
Proportion of participants achieving AN count ≤2
Time frame: Week 16
Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
Time frame: Week 16
Proportion of participants with improvement from baseline in Hurley Stage
Time frame: Week 16
Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)
Time frame: Week 16
Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)
Time frame: Week 16
Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS
Time frame: Week 16
Change from baseline in the amount of analgesic
Time frame: Up to Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 42 more locations
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs
Time frame: Up to Week 20
Plasma SAR444656 concentration
Time frame: Up to Week 16