NCT06028230

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

A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	SAR444656 (KT-474)	Oral Tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2023-09-29
• Primary completion: 2025-10-09
• Completion: 2025-11-12
• First posted: 2023-09-08
• Last updated: 2025-12-11

Locations

52 sites across 8 countries: United States, Canada, Chile, Germany, Greece, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study