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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified April 2025 by MoonLake Immunotherapeutics AG
Sponsor
MoonLake Immunotherapeutics AG
Information Provided by (Responsible Party)
MoonLake Immunotherapeutics AG
Clinicaltrials.gov Identifier
NCT06411379
Other Study ID Numbers:
M1095-HS-302
First Submitted
May 7, 2024
First Posted
May 12, 2024
Last Update Posted
May 20, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025. 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 Enrollment418 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 13, 2024
Actual Primary Completion DateJune 16, 2025
Actual Study Completion Date1mo 4w from now

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 & NRS50) 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 | Birmingham Alabama, United States, 35244Clinical Site | North Little Rock Arkansas, United States, 72117Clinical Site | Fountain Valley California, United States, 92708Clinical Site | Santa Monica California, United States, 90404Clinical Site | Aventura Florida, United States, 33180Clinical Site | Hialeah Florida, United States, 33012Clinical Site | Miami Florida, United States, 33136Clinical Site | Ocala Florida, United States, 34470Clinical Site | Tampa Florida, United States, 33613Clinical Site | Skokie Illinois, United States, 60077Clinical Site | Plainfield Indiana, United States, 46168Clinical Site | Murray Kentucky, United States, 42071Clinical Site | Baton Rouge Louisiana, United States, 70809Clinical Site | Baltimore Maryland, United States, 21287Clinical Site | Ann Arbor Michigan, United States, 48109-5314Clinical Site | Canton Michigan, United States, 48187Clinical Site | Clarkston Michigan, United States, 48346Clinical Site | Waterford Michigan, United States, 48328Clinical Site | New Brighton Minnesota, United States, 55112Clinical Site | Omaha Nebraska, United States, 68144Clinical Site | Las Vegas Nevada, United States, 89145Clinical Site | New York New York, United States, 10003Clinical Site | Fargo North Dakota, United States, 58103Clinical Site | Columbus Ohio, United States, 43213Clinical Site | Murfreesboro Tennessee, United States, 37130Clinical Site | Dallas Texas, United States, 75390-8565Clinical Site | Plano Texas, United States, 75025Clinical Site | San Antonio Texas, United States, 78213Clinical Site | Morgantown West Virginia, United States, 26505Clinical Site | Milwaukee Wisconsin, United States, 53226Clinical Site | Ghent , Belgium, 9000Clinical Site | Leuven , Belgium, 3000Clinical Site | Liège , Belgium, 4000Clinical Site | Woluwe-Saint-Lambert , Belgium, 1200Clinical Site | Sofia , Bulgaria, 1431Clinical Site | Sofia , Bulgaria, 1463Clinical Site | Sofia , Bulgaria, 1510Clinical Site | Sofia , Bulgaria, 1606Clinical Site | Stara Zagora , Bulgaria, 6003Clinical Site | Calgary Alberta, Canada, T3E 0B2Clinical Site | Edmonton Alberta, Canada, T6G 1C3Clinical Site | Guelph Ontario, Canada, N1L 0B7Clinical Site | Peterborough Ontario, Canada, K9J 5K2Clinical Site | Richmond Hill Ontario, Canada, L4B 1A5Clinical Site | Toronto Ontario, Canada, M4E 1R7Clinical Site | Windsor Ontario, Canada, N8W 1E6Clinical Site | Saskatoon Saskatchewan, Canada, S7K 2C1Clinical Site | Ostrava , Czechia, 708 52Clinical Site | Prague , Czechia, 110 00Clinical Site | Prague , Czechia, 15006Clinical Site | Antony , France, 92160Clinical Site | Besançon , France, 25030Clinical SIte | Brest , France, 29200Clinical Site | Dijon , France, 21000Clinical Site | Le Mans , France, 72037Clinical Site | Lyon , France, 69003Clinical Site | Montpellier , France, 34295Clinical Site | Rouen , France, 76031Clinical Site | Saint-Mandé , France, 94160Clinical Site | Saint-Priest-en-Jarez , France, 42270Clinical Site | Toulouse , France, 31400Clinical Site | Augsburg , Germany, 86179Clinical Site | Bad Bentheim , Germany, 48455Clinical Site | Berlin , Germany, 10117Clinical Site | Bielefeld , Germany, 33647Clinical Site | Bochum , Germany, 44791Clinical Site | Bramsche , Germany, 49565Clinical Site | Darmstadt , Germany, 64283Clinical Site | Dresden , Germany, 01307Clinical Site | Gera , Germany, 07548Clinical Site | Hamburg , Germany, 20246Clinical Site | Kiel , Germany, 24105Clinical Site | Lübeck , Germany, 23538Clinical Site | Würzburg , Germany, 97080Clinical Site | Dublin , Ireland, D04 T6F4Clinical Site | Rotterdam , Netherlands, 3015 GDClinical Site | Chorzów , Poland, 41-500Clinical Site | Katowice , Poland, 40-611Clinical Site | Kielce , Poland, 25-316Clinical Site | Olsztyn , Poland, 10-229Clinical Site | Poznan , Poland, 61-731Clinical Site | Szczecin , Poland, 70-332Clinical Site | Warsaw , Poland, 02-953Clinical Site | Wroclaw , Poland, 50566Clinical Site | Trnava , Slovakia, 91702Clinical Site | Alcorcón , Spain, 28922Clinical Site | Alicante , Spain, 03010Clinical Site | Badalona , Spain, 08916Clinical Site | Barcelona , Spain, 08003Clinical Site | Barcelona , Spain, 08036Clinical Site | Barcelona , Spain, 08041Clinical Site | Cadiz , Spain, 11009Clinical Site | Córdoba , Spain, 14004Clinical Site | Granada , Spain, 18012Clinical Site | Granada , Spain, 18014Clinical Site | Granollers , Spain, 08402Clinical Site | Madrid , Spain, 28006Clinical Site | Madrid , Spain, 28007Clinical Site | Madrid , Spain, 28041Clinical Site | Madrid , Spain, 28046Clinical Site | Manises , Spain, 46940Clinical Site | Málaga , Spain, 29010Clinical Site | Santiago de Compostela , Spain, 15706Clinical Site | Seville , Spain, 41009Clinical Site | Valencia , Spain, 46014Clinical Site | Valencia , Spain, 46026
Investigators
Study Director: Prof Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG