A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

June 5, 2026 updated by: MoonLake Immunotherapeutics AG

A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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 (Estimated)

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.
835

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 Contact Backup

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

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Clinical Site
      • Leuven, Belgium, 3000
        • Clinical Site
  • Bulgaria
      • Sofia, Bulgaria, 1407
        • Clinical Site
      • Sofia, Bulgaria, 1431
        • Clinical Site
      • Sofia, Bulgaria, 1606
        • Clinical Site
      • Sofia, Bulgaria, 1510
        • Clinical Site
    • Ontario
      • Pleven, Ontario, Bulgaria, 5800
        • Clinical Site
      • Sofia, Ontario, Bulgaria, 1463
        • Clinical Site
      • Stara Zagora, Ontario, Bulgaria, 6003
        • Clinical Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Clinical Site
      • Edmonton, Alberta, Canada, T6H 4J8
        • Clinical Site
      • Edmonton, Alberta, Canada, T6G 1C3
        • 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
      • Guelph, Ontario, Canada, N0B 2J0
        • Clinical Site
      • London, Ontario, Canada, N6H 5L5
        • Clinical Site
      • Markham, Ontario, Canada, L3P 1X3
        • Clinical Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Clinical Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Clinical Site
      • Toronto, Ontario, Canada, M2N 3A6
        • Clinical Site
      • Toronto, Ontario, Canada, M5A3R6
        • Clinical Site
      • Toronto, Ontario, Canada, M4E 1R7
        • Clinical Site
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Clinical Site
      • Québec, Quebec, Canada, G1W 4R4
        • Clinical Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 2C1
        • Clinical Site
  • Czechia
      • Ostrava, Czechia, 708 52
        • Clinical Site
      • Prague, Czechia, 110 00
        • Clinical Site
  • France
      • Brest, France, 29200
        • Clinical Site
      • Lyon, France, 69003
        • Clinical Site
      • Saint-Mandé, France, 94160
        • Clinical Site
      • Saint-Priest-en-Jarez, France, 42270
        • Clinical Site
  • Germany
      • Augsburg, Germany, 86179
        • Clinical Site
      • Bad Bentheim, Germany, 48455
        • Clinical Site
      • Berlin, Germany, 10117
        • Clinical Site
      • Berlin, Germany, 10789
        • Clinical Site
      • Bielefeld, Germany, 33647
        • Clinical Site
      • Bochum, Germany, 44791
        • Clinical Site
      • Bochum, Germany, 44793
        • Clinical Site
      • Bramsche, Germany, 49565
        • Clinical Site
      • Darmstadt, Germany, 64283
        • Clinical Site
      • Dresden, Germany, 01307
        • Clinical Site
      • Erlangen, Germany, 91054
        • Clinical Site
      • Frankfurt, Germany, 60590
        • Clinical Site
      • Hanover, Germany, 30159
        • Clinical Site
      • Kiel, Germany, 24105
        • Clinical Site
      • Langenau, Germany, 89129
        • Clinical Site
      • Lübeck, Germany, 23538
        • Clinical Site
      • Mahlow, Germany, 15831
        • Clinical Site
      • Münster, Germany, 48149
        • Clinical Site
      • Wuppertal, Germany, 42283
        • Clinical Site
      • Würzburg, Germany, 97080
        • Clinical Site
    • Saale
      • Halle, Saale, Germany, 06108
        • Clinical Site
  • Hungary
      • Debrecen, Hungary, 4032
        • Clinical Site
      • Debrecen, Hungary, 4026
        • Clinical Site
      • Pécs, Hungary, 7632
        • Clinical Site
  • Italy
      • Catania, Italy, 95123
        • Clinical Site
      • Chieti, Italy, 66013
        • Clinical Site
      • Cona, Italy, 44124
        • Clinical Site
      • Florence, Italy, 50122
        • Clinical Site
      • Milan, Italy, 20122
        • Clinical Site
      • Modena, Italy, 41126
        • Clinical Site
      • Naples, Italy, 80131
        • Clinical Site
      • Perugia, Italy, 06129
        • Clinical Site
      • Pisa, Italy, 56126
        • Clinical Site
      • Roma, Italy, 00168
        • Clinical Site
      • Rozzano, Italy, 20089
        • Clinical Site
      • Torino, Italy, 10126
        • Clinical Site
      • Torrette, Italy, 60126
        • Clinical Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Clinical Site
  • Norway
      • Oslo, Norway, 0424
        • Clinical Site
  • Poland
      • Bialystok, Poland, 15-453
        • Clinical Site
      • Chorzów, Poland, 41-516
        • Clinical Site
      • Gdansk, Poland, 80-214
        • Clinical Site
      • Katowice, Poland, 40-611
        • Clinical Site
      • Kielce, Poland, 25-316
        • 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, 60-848
        • Clinical Site
      • Poznan, Poland, 60-539
        • Clinical Site
      • Sosnowiec, Poland, 41-200
        • Clinical Site
      • Szczecin, Poland, 70-332
        • Clinical Site
      • Szczecin, Poland, 71-270
        • Clinical Site
      • Warsaw, Poland, 00-710
        • Clinical Site
      • Warsaw, Poland, 02-507
        • Clinical Site
      • Warsaw, Poland, 02-953
        • Clinical Site
      • Warsaw, Poland, 02-692
        • Clinical Site
      • Wroclaw, Poland, 51-503
        • Clinical Site
      • Wroclaw, Poland, 50566
        • Clinical Site
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Clinical Site
      • Lisbon, Portugal, 1169-050
        • Clinical Site
      • Porto, Portugal, 4050-342
        • Clinical Site
  • Slovakia
      • Trnava, Slovakia, 91775
        • Clinical Site
  • Spain
      • Alicante, Spain, 03010
        • Clinical Site
      • Badalona, Spain, 08916
        • Clinical Site
      • Barcelona, Spain, 08003
        • Clinical Site
      • Cadiz, Spain, 11009
        • Clinical Site
      • Córdoba, Spain, 14004
        • Clinical Site
      • Granada, Spain, 18012
        • Clinical Site
      • Granada, Spain, 18014
        • Clinical Site
      • Granollers, Spain, 08402
        • Clinical Site
      • Madrid, Spain, 28041
        • Clinical Site
      • Madrid, Spain, 28006
        • Clinical Site
      • Madrid, Spain, 28046
        • Clinical Site
      • Manises, Spain, 46940
        • Clinical Site
      • Málaga, Spain, 29010
        • Clinical Site
      • Santiago de Compostela, Spain, 15706
        • Clinical Site
      • Seville, Spain, 41009
        • Clinical Site
      • Valencia, Spain, 46014
        • Clinical Site
      • Valencia, Spain, 46026
        • Clinical Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Clinical Site
      • Salford, United Kingdom, M6 8HD
        • Clinical Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Clinical Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Clinical Site
    • California
      • Los Angeles, California, United States, 90404
        • Clinical Site
      • Northridge, California, United States, 91325
        • Clinical Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Clinical Site
      • Coral Gables, Florida, United States, 33134
        • Clinical Site
      • Hialeah, Florida, United States, 33012
        • Clinical Site
      • Hollywood, Florida, United States, 33021-6746
        • Clinical Site
      • Miami, Florida, United States, 33136
        • Clinical Site
      • Miami, Florida, United States, 33163
        • Clinical Site
      • Ocala, Florida, United States, 34471
        • Clinical Site
      • Tampa, Florida, United States, 33613
        • 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
      • Skokie, Illinois, United States, 60077
        • Clinical Site
      • West Dundee, Illinois, United States, 60118
        • Clinical Site
    • Indiana
      • Columbus, Indiana, United States, 47201
        • Clinical Site
      • New Albany, Indiana, United States, 47150
        • Clinical Site
      • Plainfield, Indiana, United States, 46168
        • Clinical Site
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Clinical Site
      • Murray, Kentucky, United States, 42071
        • 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
      • Ann Arbor, Michigan, United States, 48109-5314
        • Clinical Site
      • Canton, Michigan, United States, 48187
        • Clinical Site
      • Clarkston, Michigan, United States, 48346
        • Clinical Site
      • Waterford, Michigan, United States, 48328
        • Clinical Site
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Clinical Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Clinical Site
    • New York
      • New York, New York, United States, 10012
        • Clinical Site
      • New York, New York, United States, 10003
        • Clinical Site
      • The Bronx, New York, United States, 10467
        • Clinical Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Clinical Site
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Clinical Site
      • Columbus, Ohio, United States, 43213
        • Clinical Site
      • Dayton, Ohio, United States, 45324
        • Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Clinical Site
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Clinical Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Clinical Site
      • Dallas, Texas, United States, 75235
        • Clinical Site
      • Houston, Texas, United States, 77004
        • Clinical Site
      • San Antonio, Texas, United States, 78218
        • Clinical Site
      • San Antonio, Texas, United States, 78213
        • Clinical Site
    • Utah
      • South Jordan, Utah, United States, 84095
        • Clinical Site
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Clinical Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 [adult studies] or M1095-HS-304 [adolescent study]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
  • Female participants are eligible to participate if they are not pregnant or breastfeeding
  • Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

Exclusion Criteria:

  • Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
  • Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
  • Participants who plan to participate in another interventional study for a drug or device during this study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Experimental: sonelokimab
All participants will receive sonelokimab 120 mg Q4W for up to 2 years
Drug: Sonelokimab
Sonelokimab

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
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
Time Frame: 2.5-3 years
Incidence, relatedness, severity and seriousness of all AEs
2.5-3 years
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
Time Frame: 2.5-3 years
Incidence, relatedness, severity and seriousness of all TEAEs
2.5-3 years
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
Time Frame: 2.5-3 years
Incidence, relatedness, severity and seriousness of all AESIs
2.5-3 years
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
Time Frame: 2.5-3 years
Number of participants discontinued from sonelokimab treatment due to AEs
2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
Time Frame: 2.5-3 years
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
2.5-3 years
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
Time Frame: 2.5-3 years
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
2.5-3 years

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
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Time Frame: 2.5 - 3 years
Percentage of participants achieving a HiSCR75 response over time
2.5 - 3 years
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)
Time Frame: 2.5 - 3 years
Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time
2.5 - 3 years
Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)
Time Frame: 2.5 - 3 years
Absolute change in IHS4 score over time
2.5 - 3 years
Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules
Time Frame: 2.5 - 3 years
Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules
2.5 - 3 years
Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)
Time Frame: 2.5 - 3 years
Change in DLQI total score
2.5 - 3 years
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)
Time Frame: 2.5 - 3 years
Change in HiSQOL total score
2.5 - 3 years

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

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.
June 27, 2025

Primary Completion (Estimated)

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.
June 13, 2028

Study Completion (Estimated)

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.
June 13, 2028

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 28, 2025

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 28, 2025

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.
June 6, 2025

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.
June 8, 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.
June 5, 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.
June 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-303
  • VELA-OLE (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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