Secondary endpoints: details revised at 6 of 16 entries
MinorStudy sites: 66 to 67
Study completion date: Dec 1, 2027 to Nov 19, 2027
v13
MinorTrial sites expanded: 63 → 66 locationsv12
MinorTrial sites expanded: 58 → 63 locationsv11
MinorTrial sites expanded: 46 → 58 locationsv10
MinorTrial sites expanded: 43 → 46 locations
Secondary endpoints revised (16)
v9
MinorTrial sites expanded: 20 → 43 locationsv8
MinorTrial sites expanded: 17 → 20 locationsv7
MinorStudy sites: 9 to 17v6
MinorStudy sites: 5 to 9v5
MinorStudy sites: 1 to 5v4
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 1
Start date changed from estimate of Dec 26, 2025 to Dec 29, 2025
v3
MinorStudy sites: 1 to 0v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.
The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.
The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.