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

August 11, 2026 updated by: MoonLake Immunotherapeutics AG

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
422

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hidradenitis Suppurativa Clinical Response 75
Time Frame: Week 16
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in International Hidradenitis Suppurativa Severity Score System
Time Frame: Week 16

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)
Time Frame: Week 16
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)
Time Frame: Week 16
Percentage of participants achieving HiSCR50
Week 16
Dermatology Life Quality Index (DLQI)
Time Frame: Week 16
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)
Time Frame: Week 16 and Week 52
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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MoonLake Immunotherapeutics AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Prof Kristian Reich, M.D., Ph.D. (equ.), MoonLake Immunotherapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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