Trials / Active Not Recruiting
Active Not RecruitingNCT06411379
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 418 (actual)
- Sponsor
- MoonLake Immunotherapeutics AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sonelokimab | Sonelokimab |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2024-05-14
- Primary completion
- 2025-06-17
- Completion
- 2026-06-17
- First posted
- 2024-05-13
- Last updated
- 2025-05-21
Locations
106 sites across 12 countries: United States, Belgium, Bulgaria, Canada, Czechia, France, Germany, Ireland, Netherlands, Poland, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06411379. Inclusion in this directory is not an endorsement.