Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT ID: NCT06411379
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
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ACTIVE_NOT_RECRUITING
PHASE3
418 participants
INTERVENTIONAL
2024-05-14
2026-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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Sonelokimab
Sonelokimab
Placebo
Placebo
Eligibility Criteria
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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
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MoonLake Immunotherapeutics AG
INDUSTRY
Responsible Party
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Principal Investigators
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Prof Kristian Reich, M.D., Ph.D. (equ.)
Role: STUDY_DIRECTOR
MoonLake Immunotherapeutics AG
Locations
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Clinical Site
Birmingham, Alabama, United States
Clinical Site
North Little Rock, Arkansas, United States
Clinical Site
Fountain Valley, California, United States
Clinical Site
Santa Monica, California, United States
Clinical Site
Aventura, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Ocala, Florida, United States
Clinical Site
Tampa, Florida, United States
Clinical Site
Skokie, Illinois, United States
Clinical Site
Plainfield, Indiana, United States
Clinical Site
Murray, Kentucky, United States
Clinical Site
Baton Rouge, Louisiana, United States
Clinical Site
Baltimore, Maryland, United States
Clinical Site
Ann Arbor, Michigan, United States
Clinical Site
Canton, Michigan, United States
Clinical Site
Clarkston, Michigan, United States
Clinical Site
Waterford, Michigan, United States
Clinical Site
New Brighton, Minnesota, United States
Clinical Site
Omaha, Nebraska, United States
Clinical Site
Las Vegas, Nevada, United States
Clinical Site
New York, New York, United States
Clinical Site
Fargo, North Dakota, United States
Clinical Site
Columbus, Ohio, United States
Clinical Site
Murfreesboro, Tennessee, United States
Clinical Site
Dallas, Texas, United States
Clinical Site
Plano, Texas, United States
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San Antonio, Texas, United States
Clinical Site
Morgantown, West Virginia, United States
Clinical Site
Milwaukee, Wisconsin, United States
Clinical Site
Ghent, , Belgium
Clinical Site
Leuven, , Belgium
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Liège, , Belgium
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Woluwe-Saint-Lambert, , Belgium
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Calgary, Alberta, Canada
Clinical Site
Edmonton, Alberta, Canada
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Guelph, Ontario, Canada
Clinical Site
Peterborough, Ontario, Canada
Clinical Site
Richmond Hill, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
Clinical Site
Saskatoon, Saskatchewan, Canada
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Ostrava, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Prague, , Czechia
Clinical Site
Antony, , France
Clinical Site
Besançon, , France
Clinical SIte
Brest, , France
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Dijon, , France
Clinical Site
Le Mans, , France
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Lyon, , France
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Montpellier, , France
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Rouen, , France
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Saint-Mandé, , France
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Saint-Priest-en-Jarez, , France
Clinical Site
Toulouse, , France
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Augsburg, , Germany
Clinical Site
Bad Bentheim, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
Clinical Site
Bochum, , Germany
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Bramsche, , Germany
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Darmstadt, , Germany
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Dresden, , Germany
Clinical Site
Gera, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Würzburg, , Germany
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Dublin, , Ireland
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Rotterdam, , Netherlands
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Chorzów, , Poland
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Katowice, , Poland
Clinical Site
Kielce, , Poland
Clinical Site
Olsztyn, , Poland
Clinical Site
Poznan, , Poland
Clinical Site
Szczecin, , Poland
Clinical Site
Warsaw, , Poland
Clinical Site
Wroclaw, , Poland
Clinical Site
Trnava, , Slovakia
Clinical Site
Alcorcón, , Spain
Clinical Site
Alicante, , Spain
Clinical Site
Badalona, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Barcelona, , Spain
Clinical Site
Cadiz, , Spain
Clinical Site
Córdoba, , Spain
Clinical Site
Granada, , Spain
Clinical Site
Granada, , Spain
Clinical Site
Granollers, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Madrid, , Spain
Clinical Site
Manises, , Spain
Clinical Site
Málaga, , Spain
Clinical Site
Santiago de Compostela, , Spain
Clinical Site
Seville, , Spain
Clinical Site
Valencia, , Spain
Clinical Site
Valencia, , Spain
Countries
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Other Identifiers
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VELA-2
Identifier Type: OTHER
Identifier Source: secondary_id
M1095-HS-302
Identifier Type: -
Identifier Source: org_study_id
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