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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2026 by MoonLake Immunotherapeutics AG
Sponsor
MoonLake Immunotherapeutics AG
Information Provided by (Responsible Party)
MoonLake Immunotherapeutics AG
Clinicaltrials.gov Identifier
NCT06411899
Other Study ID Numbers:
M1095-HS-301
First Submitted
May 7, 2024
First Posted
May 12, 2024
Last Update Posted
June 7, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Hidradenitis Suppurativa
Drug: SonelokimabDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment422 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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
Study Start DateMay 14, 2024
Actual Primary Completion DateSeptember 1, 2025
Actual Study Completion DateMay 13, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
    Percentage of participants achieving HiSCR50
  2. 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.
  3. 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.
  4. 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
  5. 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).
  6. 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)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsMoonLake Immunotherapeutics AG
Locations
Clinical Site | Los Angeles California, United States, 90024Clinical Site | Northridge California, United States, 91325Clinical Site | Sacramento California, United States, 95815Clinical Site | San Diego California, United States, 92123Clinical Site | Coral Gables Florida, United States, 33134Clinical Site | Coral Springs Florida, United States, 33071Clinical Site | Hollywood Florida, United States, 33201Clinical Site | Margate Florida, United States, 33063Clinical Site | Miami Florida, United States, 33161Clinical Site | Tampa Florida, United States, 33607Clinical Site | Macon Georgia, United States, 31217Clinical Site | Sandy Springs Georgia, United States, 30328Clinical Site | West Dundee Illinois, United States, 60118Clinical Site | Columbus Indiana, United States, 47201Clinical Site | New Albany Indiana, United States, 47150Clinical Site | Louisville Kentucky, United States, 40241Clinical Site | Metairie Louisiana, United States, 70006Clinical Site | Boston Massachusetts, United States, 02116Clinical Site | Boston Massachusetts, United States, 02215Clinical Site | Dearborn Michigan, United States, 48126Clinical Site | Warren Michigan, United States, 48088Clinical Site | Las Vegas Nevada, United States, 89119Clinical Site | New York New York, United States, 10012Clinical Site | The Bronx New York, United States, 10467Clinical Site | Boardman Ohio, United States, 44512Clinical Site | Dayton Ohio, United States, 45324Clinical Site | Mayfield Heights Ohio, United States, 44124Clinical Site | Oklahoma City Oklahoma, United States, 73118Clinical Site | Charleston South Carolina, United States, 29425Clinical Site | Nashville Tennessee, United States, 37215Clinical Site | Frisco Texas, United States, 75034Clinical Site | Houston Texas, United States, 77004Clinical Site | Houston Texas, United States, 77082Clinical Site | South Jordan Utah, United States, 84095Clinical Site | Forest Virginia, United States, 24551Clinical Site | Mill Creek Washington, United States, 98012Clinical SIte | Pleven , Bulgaria, 5800Clinical Site | Sofia , Bulgaria, 1407Clinical Site | Sofia , Bulgaria, 1527Clinical Site | Sofia , Bulgaria, 1606Clinical Site | Edmonton Alberta, Canada, T5J 3S9Clinical Site | Edmonton Alberta, Canada, T6H 4J8Clinical Site | Sherwood Park Alberta, Canada, T8H 0P1Clinical Site | Winnipeg Manitoba, Canada, R3M 3Z4Clinical Site | Fredericton New Brunswick, Canada, E3B 1G9Clinical Site | Barrie Ontario, Canada, L4M 7G1Clinical Site | London Ontario, Canada, N6H 5L5Clinical Site | Markham Ontario, Canada, L3P 1X3Clinical Site | Newmarket Ontario, Canada, L3Y 5G8Clinical Site | Toronto Ontario, Canada, M2N 3A6Clinical Site | Toronto Ontario, Canada, M5A3R6Clinical Site | Montreal Quebec, Canada, H1Y 3L1Clinical Site | Québec Quebec, Canada, G1W 4R4Clinical Site | Sherbrooke Quebec, Canada, J1G 1X9Clinical Site | Berlin , Germany, 10789Clinical Site | Bochum , Germany, 44805Clinical Site | Buxtehude , Germany, 21614Clinical Site | Erlangen , Germany, 91054Clinical Site | Essen , Germany, 45147Clinical Site | Frankfurt , Germany, 60590Clinical SIte | Halle , Germany, 06108Clinical Site | Hanover , Germany, 30159Clinical Site | Langenau , Germany, 89129Clinical Site | Mahlow , Germany, 15831Clinical Site | München , Germany, 80337Clinical Site | Münster , Germany, 48149Clinical Site | Oldenburg , Germany, 26133Clinical Site | Wuppertal , Germany, 42283Clinical Site | Budapest , Hungary, 1036Clinical Site | Debrecen , Hungary, 4031Clinical Site | Debrecen , Hungary, 4032Clinical Site | Pécs , Hungary, 7632Clinical Site | Brescia , Italy, 25123Clinical Site | Catania , Italy, 95123Clinical Site | Chieti , Italy, 66100Clinical Site | Cona , Italy, 44124Clinical Site | Florence , Italy, 50125Clinical Site | Milan , Italy, 20122Clinical Site | Modena , Italy, 41124Clinical Site | Naples , Italy, 80131Clinical Site | Perugia , Italy, 06129Clinical Site | Pisa , Italy, 56126Clinical Site | Rome , Italy, 00168Clinical Site | Rozzano , Italy, 20089Clinical Site | Torino , Italy, 10126Clinical Site | Torrette , Italy, 60020Clinical Site | Oslo , Norway, 0372Clinical Site | Bialystok , Poland, 15-453Clinical Site | Gdansk , Poland, 80-214Clinical Site | Krakow , Poland, 30-002Clinical Site | Krakow , Poland, 30-727Clinical Site | Lodz , Poland, 90-265Clinical Site | Lodz , Poland, 90-436Clinical Site | Lublin , Poland, 20-573Clinical Site | Ossy , Poland, 42-624Clinical Site | Poznan , Poland, 60-529Clinical Site | Sosnowiec , Poland, 41-200Clinical Site | Szczecin , Poland, 71-500Clinical Site | Warsaw , Poland, 00-710Clinical Site | Warsaw , Poland, 02-507Clinical Site | Warsaw , Poland, 02-692Clinical Site | Wroclaw , Poland, 51-503Clinical Site | Lisbon , Portugal, 1169-050Clinical Site | Lisbon , Portugal, 1649-035Clinical Site | Porto , Portugal, 4050-342Clinical Site | Cardiff , United Kingdom, CF14 4XWClinical Site | Dudley , United Kingdom, DY1 2HQClinical Site | Leeds , United Kingdom, LS9 7TFClinical Site | Salford , United Kingdom, M6 8HD
Investigators
Study Director: Prof Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG