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Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

NCT06411379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2025-05-21

No results posted yet for this study

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

DRUG

Sonelokimab

Sonelokimab

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • MoonLake Immunotherapeutics AG

    lead INDUSTRY

Principal Investigators

  • Prof Kristian Reich, M.D., Ph.D. (equ.) · MoonLake Immunotherapeutics AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2025-06-17
Completion
2026-06-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • Netherlands
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06411379 on ClinicalTrials.gov