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

NCT06411899 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M1095-HS-301VELA-1
• Study Type: interventional
• Target: 422
• Locations: 10 countries
• Sites: 109

Brief 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

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Suppuration; Anti-Inflammatory Agents; Sonelokimab; Nanobody; Apocrine Gland Disease

Outcome Measures

Primary Outcomes (1)

• Hidradenitis Suppurativa Clinical Response 75

  Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.

  Week 16

Secondary Outcomes (6)

• Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

  Week 16

• Change in International Hidradenitis Suppurativa Severity Score System

  Week 16

• Dermatology Life Quality Index (DLQI)

  Week 16

• Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)

  Week 16

• Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16

  Week 16

Study Arms (2)

sonelokimab

EXPERIMENTAL

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.

Drug: Sonelokimab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sonelokimab DRUG

Sonelokimab

sonelokimab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be at least 18 years of age at the time of signing the informed consent.
• 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.
• 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.
• Participants who have a total AN count of ≥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).

You may not qualify if:

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
• Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
• 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.
• 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.
• Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (109)

Clinical Site

Los Angeles, California, 90024, United States

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Northridge, California, 91325, United States

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Sacramento, California, 95815, United States

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San Diego, California, 92123, United States

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Coral Gables, Florida, 33134, United States

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Coral Springs, Florida, 33071, United States

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Hollywood, Florida, 33201, United States

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Margate, Florida, 33063, United States

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Miami, Florida, 33161, United States

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Tampa, Florida, 33607, United States

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Macon, Georgia, 31217, United States

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Sandy Springs, Georgia, 30328, United States

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West Dundee, Illinois, 60118, United States

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Columbus, Indiana, 47201, United States

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New Albany, Indiana, 47150, United States

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Louisville, Kentucky, 40241, United States

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Metairie, Louisiana, 70006, United States

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Boston, Massachusetts, 02116, United States

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Boston, Massachusetts, 02215, United States

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Dearborn, Michigan, 48126, United States

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Warren, Michigan, 48088, United States

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Las Vegas, Nevada, 89119, United States

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New York, New York, 10012, United States

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The Bronx, New York, 10467, United States

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Boardman, Ohio, 44512, United States

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Dayton, Ohio, 45324, United States

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Mayfield Heights, Ohio, 44124, United States

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Oklahoma City, Oklahoma, 73118, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37215, United States

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Frisco, Texas, 75034, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77082, United States

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South Jordan, Utah, 84095, United States

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Forest, Virginia, 24551, United States

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Mill Creek, Washington, 98012, United States

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Pleven, 5800, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Edmonton, Alberta, T5J 3S9, Canada

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Edmonton, Alberta, T6H 4J8, Canada

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Sherwood Park, Alberta, T8H 0P1, Canada

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Winnipeg, Manitoba, R3M 3Z4, Canada

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Fredericton, New Brunswick, E3B 1G9, Canada

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Barrie, Ontario, L4M 7G1, Canada

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London, Ontario, N6H 5L5, Canada

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Markham, Ontario, L3P 1X3, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Toronto, Ontario, M2N 3A6, Canada

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Toronto, Ontario, M5A3R6, Canada

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Montreal, Quebec, H1Y 3L1, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1G 1X9, Canada

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Berlin, 10789, Germany

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Bochum, 44805, Germany

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Buxtehude, 21614, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Halle, 06108, Germany

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Hanover, 30159, Germany

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Langenau, 89129, Germany

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Mahlow, 15831, Germany

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München, 80337, Germany

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Münster, 48149, Germany

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Oldenburg, 26133, Germany

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Wuppertal, 42283, Germany

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Budapest, 1036, Hungary

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Debrecen, 4031, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7632, Hungary

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Brescia, 25123, Italy

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Catania, 95123, Italy

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Chieti, 66100, Italy

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Cona, 44124, Italy

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Florence, 50125, Italy

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Milan, 20122, Italy

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Modena, 41124, Italy

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Napoli, 80131, Italy

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Perugia, 06129, Italy

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Pisa, 56126, Italy

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Rome, 00168, Italy

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Rozzano, 20089, Italy

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Torino, 10126, Italy

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Torrette, 60020, Italy

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Oslo, 0372, Norway

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Bialystok, 15-453, Poland

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Gdansk, 80-214, Poland

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Krakow, 30-002, Poland

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Krakow, 30-727, Poland

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Lodz, 90-265, Poland

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Lodz, 90-436, Poland

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Lublin, 20-573, Poland

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Ossy, 42-624, Poland

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Poznan, 60-529, Poland

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Sosnowiec, 41-200, Poland

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Szczecin, 71-500, Poland

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Warsaw, 00-710, Poland

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Warsaw, 02-507, Poland

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Warsaw, 02-692, Poland

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Wroclaw, 51-503, Poland

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Lisbon, 1169-050, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4050-342, Portugal

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Cardiff, CF14 4XW, United Kingdom

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Dudley, DY1 2HQ, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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Salford, M6 8HD, United Kingdom

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MeSH Terms

Conditions

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Suppuration

Interventions

sonelokimab

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof Kristian Reich, M.D., Ph.D. (equ.)

  MoonLake Immunotherapeutics AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: May 15, 2024
• Primary Completion: June 17, 2025
• Study Completion (Estimated): June 17, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

HU (4); CA (14); PL (15); NO (1); IT (14); DE (14); US (36); BU (4); GB (4); PT (3)