A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520564-17-00

Acronym

M1095-HS-303

Enrollment

492

Registered

2025-08-29

Start date

2025-10-16

Completion date

Unknown

Last updated

2025-12-23

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

1. Treatment-emergent adverse event (TEAEs), 2. Serious adverse event (SAEs), 3. TEAEs leading to study withdrawal, 4. Adverse event of special interest (AESIs), 5. Vital signs, and ECG results, 6. Abnormal laboratory parameters (hematology, clinical chemistry)

Interventions

DRUGSonelokimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Treatment-emergent adverse event (TEAEs), 2. Serious adverse event (SAEs), 3. TEAEs leading to study withdrawal, 4. Adverse event of special interest (AESIs), 5. Vital signs, and ECG results, 6. Abnormal laboratory parameters (hematology, clinical chemistry)	—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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