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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

835

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

June 27, 2025

Primary Completion (Estimated)

June 13, 2028

Study Completion (Estimated)

June 13, 2028

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

May 28, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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