A 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

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Placebo; Drug: Sonelokimab

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Clinical Site
  • Sofia, Bulgaria, 1407
    • Clinical Site
  • Sofia, Bulgaria, 1527
    • Clinical Site
  • Sofia, Bulgaria, 1606
    • Clinical Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Clinical Site
    • Edmonton, Alberta, Canada, T6H 4J8
      • Clinical Site
    • Sherwood Park, Alberta, Canada, T8H 0P1
      • Clinical Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Clinical Site
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Clinical Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Clinical Site
    • London, Ontario, Canada, N6H 5L5
      • Clinical Site
    • Markham, Ontario, Canada, L3P 1X3
      • Clinical Site
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Clinical Site
    • Toronto, Ontario, Canada, M2N 3A6
      • Clinical Site
    • Toronto, Ontario, Canada, M5A3R6
      • Clinical Site
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3L1
      • Clinical Site
    • Québec, Quebec, Canada, G1W 4R4
      • Clinical Site
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Clinical Site
• Germany
  • Berlin, Germany, 10789
    • Clinical Site
  • Bochum, Germany, 44805
    • Clinical Site
  • Buxtehude, Germany, 21614
    • Clinical Site
  • Erlangen, Germany, 91054
    • Clinical Site
  • Essen, Germany, 45147
    • Clinical Site
  • Frankfurt, Germany, 60590
    • Clinical Site
  • Halle, Germany, 06108
    • Clinical Site
  • Hanover, Germany, 30159
    • Clinical Site
  • Langenau, Germany, 89129
    • Clinical Site
  • Mahlow, Germany, 15831
    • Clinical Site
  • München, Germany, 80337
    • Clinical Site
  • Münster, Germany, 48149
    • Clinical Site
  • Oldenburg, Germany, 26133
    • Clinical Site
  • Wuppertal, Germany, 42283
    • Clinical Site
• Hungary
  • Budapest, Hungary, 1036
    • Clinical Site
  • Debrecen, Hungary, 4032
    • Clinical Site
  • Debrecen, Hungary, 4031
    • Clinical Site
  • Pécs, Hungary, 7632
    • Clinical Site
• Italy
  • Brescia, Italy, 25123
    • Clinical Site
  • Catania, Italy, 95123
    • Clinical Site
  • Chieti, Italy, 66100
    • Clinical Site
  • Cona, Italy, 44124
    • Clinical Site
  • Florence, Italy, 50125
    • Clinical Site
  • Milan, Italy, 20122
    • Clinical Site
  • Modena, Italy, 41124
    • Clinical Site
  • Naples, Italy, 80131
    • Clinical Site
  • Perugia, Italy, 06129
    • Clinical Site
  • Pisa, Italy, 56126
    • Clinical Site
  • Rome, Italy, 00168
    • Clinical Site
  • Rozzano, Italy, 20089
    • Clinical Site
  • Torino, Italy, 10126
    • Clinical Site
  • Torrette, Italy, 60020
    • Clinical Site
• Norway
  • Oslo, Norway, 0372
    • Clinical Site
• Poland
  • Bialystok, Poland, 15-453
    • Clinical Site
  • Gdansk, Poland, 80-214
    • Clinical Site
  • Krakow, Poland, 30-002
    • Clinical Site
  • Krakow, Poland, 30-727
    • Clinical Site
  • Lodz, Poland, 90-265
    • Clinical Site
  • Lodz, Poland, 90-436
    • Clinical Site
  • Lublin, Poland, 20-573
    • Clinical Site
  • Ossy, Poland, 42-624
    • Clinical Site
  • Poznan, Poland, 60-529
    • Clinical Site
  • Sosnowiec, Poland, 41-200
    • Clinical Site
  • Szczecin, Poland, 71-500
    • Clinical Site
  • Warsaw, Poland, 00-710
    • Clinical Site
  • Warsaw, Poland, 02-507
    • Clinical Site
  • Warsaw, Poland, 02-692
    • Clinical Site
  • Wroclaw, Poland, 51-503
    • Clinical Site
• Portugal
  • Lisbon, Portugal, 1649-035
    • Clinical Site
  • Lisbon, Portugal, 1169-050
    • Clinical Site
  • Porto, Portugal, 4050-342
    • Clinical Site
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Clinical Site
  • Dudley, United Kingdom, DY1 2HQ
    • Clinical Site
  • Leeds, United Kingdom, LS9 7TF
    • Clinical Site
  • Salford, United Kingdom, M6 8HD
    • Clinical Site
• United States
  • California
    • Los Angeles, California, United States, 90024
      • Clinical Site
    • Northridge, California, United States, 91325
      • Clinical Site
    • Sacramento, California, United States, 95815
      • Clinical Site
    • San Diego, California, United States, 92123
      • Clinical Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Site
    • Coral Springs, Florida, United States, 33071
      • Clinical Site
    • Hollywood, Florida, United States, 33201
      • Clinical Site
    • Margate, Florida, United States, 33063
      • Clinical Site
    • Miami, Florida, United States, 33161
      • Clinical Site
    • Tampa, Florida, United States, 33607
      • Clinical Site
  • Georgia
    • Macon, Georgia, United States, 31217
      • Clinical Site
    • Sandy Springs, Georgia, United States, 30328
      • Clinical Site
  • Illinois
    • West Dundee, Illinois, United States, 60118
      • Clinical Site
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Clinical Site
    • New Albany, Indiana, United States, 47150
      • Clinical Site
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Clinical Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Clinical Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Clinical Site
    • Boston, Massachusetts, United States, 02116
      • Clinical Site
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Clinical Site
    • Warren, Michigan, United States, 48088
      • Clinical Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Site
  • New York
    • New York, New York, United States, 10012
      • Clinical Site
    • The Bronx, New York, United States, 10467
      • Clinical Site
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Clinical Site
    • Dayton, Ohio, United States, 45324
      • Clinical Site
    • Mayfield Heights, Ohio, United States, 44124
      • Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Clinical Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Clinical Site
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Clinical Site
  • Texas
    • Frisco, Texas, United States, 75034
      • Clinical Site
    • Houston, Texas, United States, 77004
      • Clinical Site
    • Houston, Texas, United States, 77082
      • Clinical Site
  • Utah
    • South Jordan, Utah, United States, 84095
      • Clinical Site
  • Virginia
    • Forest, Virginia, United States, 24551
      • Clinical Site
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants must be at least 18 years of age at the time of signing the informed consent.
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:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Sonelokimab; Sonelokimab
Placebo Comparator: 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	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Hidradenitis Suppurativa Severity Score System	Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.	Week 16
Reduction from Numerical Rating Scale (NRS30 & NR550) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)	Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3	Week 16
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)	Percentage of participants achieving HiSCR50	Week 16
Dermatology Life Quality Index (DLQI)	Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.	Week 16
Resolution of draining tunnels (DT100)	Percentage of participants with zero draining tunnels in the subgroup of participants with at least one draining tunnel at baseline (DT100)	Week 16 and Week 52
Patient Global Impression-Severity of Illness-Hidradenitis Suppurativa at Week 16	Percentage of participants with minimal or absent symptoms using the Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16. Participants choose the response that best describes the severity of their disease. The question is rated on a 7-point scale ranging from 0 to 6 (0=absent; 1=minimal; 2=mild; 3=moderate; 4=moderately severe; 5=severe; 6=very severe).	Week 16

Collaborators and Investigators

• Sponsor: MoonLake Immunotherapeutics AG
• Investigators: Study Director: Prof Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): September 2, 2025
• Study Completion (Actual): May 14, 2026

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Skin Diseases; Anti-Inflammatory Agents; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Suppuration; Sonelokimab; Nanobody; Apocrine Gland Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Hidradenitis; Skin Diseases; Skin Diseases, Bacterial; Sweat Gland Diseases; Suppuration; sonelokimab
• Other Study ID Numbers: M1095-HS-301; VELA-1 (Other Identifier: Sponsor)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No