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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511360-87-00

Acronym

M1095-HS-301

Enrollment

262

Registered

2024-09-02

Start date

2024-10-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hidradenitis suppurativa (HS)

Brief summary

Percentage of participants achieving HiSCR75 score at Week 16

Detailed description

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

Interventions

DRUGPlacebo is a sterile solution in a single use prefilled syringe (PFS) intended for subcutaneous administration

DRUGSonelokimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants achieving HiSCR75 score at Week 16	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Countries

Austria, Bulgaria, Germany, Hungary, Italy, Norway, Poland, Portugal

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026