A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06411899
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
422 participants
INTERVENTIONAL
2024-05-15
2026-06-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06411379
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
NCT07007637
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
NCT05322473
A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa
NCT04019041
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
NCT03628924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sonelokimab
Subjects randomized to this arm will receive sonelokimab 120 mg Q2W from Weeks 0 to 6 then 120 mg Q4W starting at Week 8 up to Week 48.
Sonelokimab
Sonelokimab
Placebo
Subjects randomized to this arm will receive placebo Q2W from Weeks 0 to 6 then Q4W starting at Week 8 up to Week 16. They will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16 to 22 then Q4W from Week 24 up to Week 48
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sonelokimab
Sonelokimab
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).
Exclusion Criteria
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MoonLake Immunotherapeutics AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof Kristian Reich, M.D., Ph.D. (equ.)
Role: STUDY_DIRECTOR
MoonLake Immunotherapeutics AG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Site
Los Angeles, California, United States
Clinical Site
Northridge, California, United States
Clinical Site
Sacramento, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
Coral Gables, Florida, United States
Clinical Site
Coral Springs, Florida, United States
Clinical Site
Hollywood, Florida, United States
Clinical Site
Margate, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Macon, Georgia, United States
Clinical Site
Sandy Springs, Georgia, United States
Clinical Site
West Dundee, Illinois, United States
Clinical Site
Columbus, Indiana, United States
Clinical Site
New Albany, Indiana, United States
Clinical Site
Louisville, Kentucky, United States
Clinical Site
Metairie, Louisiana, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Boston, Massachusetts, United States
Clinical Site
Dearborn, Michigan, United States
Clinical Site
Warren, Michigan, United States
Clinical Site
Las Vegas, Nevada, United States
Clinical Site
New York, New York, United States
Clinical Site
The Bronx, New York, United States
Clinical Site
Boardman, Ohio, United States
Clinical Site
Dayton, Ohio, United States
Clinical Site
Mayfield Heights, Ohio, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Charleston, South Carolina, United States
Clinical Site
Nashville, Tennessee, United States
Clinical Site
Frisco, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
South Jordan, Utah, United States
Clinical Site
Forest, Virginia, United States
Clinical Site
Mill Creek, Washington, United States
Clinical SIte
Pleven, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Edmonton, Alberta, Canada
Clinical Site
Edmonton, Alberta, Canada
Clinical Site
Sherwood Park, Alberta, Canada
Clinical Site
Winnipeg, Manitoba, Canada
Clinical Site
Fredericton, New Brunswick, Canada
Clinical Site
Barrie, Ontario, Canada
Clinical Site
London, Ontario, Canada
Clinical Site
Markham, Ontario, Canada
Clinical Site
Newmarket, Ontario, Canada
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Toronto, Ontario, Canada
Clinical Site
Montreal, Quebec, Canada
Clinical Site
Québec, Quebec, Canada
Clinical Site
Sherbrooke, Quebec, Canada
Clinical Site
Berlin, , Germany
Clinical Site
Bochum, , Germany
Clinical Site
Buxtehude, , Germany
Clinical Site
Erlangen, , Germany
Clinical Site
Essen, , Germany
Clinical Site
Frankfurt, , Germany
Clinical SIte
Halle, , Germany
Clinical Site
Hanover, , Germany
Clinical Site
Langenau, , Germany
Clinical Site
Mahlow, , Germany
Clinical Site
München, , Germany
Clinical Site
Münster, , Germany
Clinical Site
Oldenburg, , Germany
Clinical Site
Wuppertal, , Germany
Clinical Site
Budapest, , Hungary
Clinical Site
Debrecen, , Hungary
Clinical Site
Debrecen, , Hungary
Clinical Site
Pécs, , Hungary
Clinical Site
Brescia, , Italy
Clinical Site
Catania, , Italy
Clinical Site
Chieti, , Italy
Clinical Site
Cona, , Italy
Clinical Site
Florence, , Italy
Clinical Site
Milan, , Italy
Clinical Site
Modena, , Italy
Clinical Site
Napoli, , Italy
Clinical Site
Perugia, , Italy
Clinical Site
Pisa, , Italy
Clinical Site
Rome, , Italy
Clinical Site
Rozzano, , Italy
Clinical Site
Torino, , Italy
Clinical Site
Torrette, , Italy
Clinical Site
Oslo, , Norway
Clinical Site
Bialystok, , Poland
Clinical Site
Gdansk, , Poland
Clinical Site
Krakow, , Poland
Clinical Site
Krakow, , Poland
Clinical Site
Lodz, , Poland
Clinical Site
Lodz, , Poland
Clinical Site
Lublin, , Poland
Clinical Site
Ossy, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Sosnowiec, , Poland
Clinical Site
Szczecin, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Wroclaw, , Poland
Clinical Site
Lisbon, , Portugal
Clinical Site
Lisbon, , Portugal
Clinical Site
Porto, , Portugal
Clinical Site
Cardiff, , United Kingdom
Clinical Site
Dudley, , United Kingdom
Clinical Site
Leeds, , United Kingdom
Clinical Site
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VELA-1
Identifier Type: OTHER
Identifier Source: secondary_id
M1095-HS-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.