A phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (M1095-HS-301)

Trial status: Authorised 6. Treatment-emergent adverse event (TEAEs), 7. SAEs, 8. TEAEs leading to study withdrawal, 9. Adverse event of special interest (AESIs), 10. Physical examinations, vital signs, and ECG results, 11. Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16., 4. Absolute change in HiSQOL score at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4 ., 2. Percentage of participants achieving IHS4-55 at Week 16., 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3 Percentage of participants achieving HiSCR75 score at Week 16

6. Treatment-emergent adverse event (TEAEs), 7. SAEs, 8. TEAEs leading to study withdrawal, 9. Adverse event of special interest (AESIs), 10. Physical examinations, vital signs, and ECG results, 11. Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16., 4. Absolute change in HiSQOL score at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4 ., 2. Percentage of participants achieving IHS4-55 at Week 16., 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 262 participants