A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa

Hidradenitis suppurativa

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4), Percentage of participants achieving Achievement of Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Percent change from baseline to Week 16 in draining tunnel count, Absolute change from baseline to Week 16 in draining tunnel count, Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) item 1 from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3, Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS), Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) score, Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score, Change from baseline to Week 16 in Weekly average HS SAQ score items, Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) score, Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, Number of participants with Treatment Emergent Adverse Events (TEAEs) Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) including administration site reactions, Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs), Serum concentrations of SAR445399 throughout the study, Incidence of anti drug antibodies (ADA) of SAR445399 at prespecified timepoints

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