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

Last updated: January 9, 2025
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Recruiting

Phase

3

Condition

Acne Inversa

Rosacea

Hidradenitis Suppurativa

Treatment

Sonelokimab

Placebo

Clinical Study ID

NCT06411899
M1095-HS-301
VELA-1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be at least 18 years of age at the time of signing the informedconsent.

  2. Participants who are diagnosed with hidradenitis suppurativa as determined by theinvestigator and have a history of signs and symptoms of hidradenitis suppurativafor at least 6 months before signing the informed consent.

  3. Participants who have had an inadequate response to appropriate systemic antibioticsfor treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had acontraindication to, systemic antibiotics for treatment of their HS), in theinvestigator'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 leastone of which must contain single or multiple fistulas (ie, be Hurley Stage II orIII).

Exclusion

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 theopinion 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) theparticipant at increased risk in the investigator's opinion, would preclude theparticipant from adhering to the protocol or completing the study per protocol.

  5. Participants with any other known autoimmune disease or any medical condition thatin the opinion of the investigator would interfere with an accurate assessment ofclinical symptoms of HS.

  6. Participants with a gastrointestinal condition including inflammatory bowel diseaseor diagnosis of ulcerative colitis or Crohn's disease.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Sonelokimab
Phase: 3
Study Start date:
May 15, 2024
Estimated Completion Date:
June 17, 2026

Connect with a study center

  • Clinical SIte

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Sherwood Park, Alberta T8H 0P1
    Canada

    Active - Recruiting

  • Clinical Site

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Active - Recruiting

  • Clinical Site

    Fredericton, New Brunswick E3B 1G9
    Canada

    Active - Recruiting

  • Clinical Site

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Clinical Site

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • Clinical Site

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Clinical Site

    Newmarket, Ontario L3Y 5G8
    Canada

    Active - Recruiting

  • Clinical Site

    Toronto, Ontario M5A3R6
    Canada

    Active - Recruiting

  • Clinical Site

    Montréal, Quebec H1Y 3L1
    Canada

    Active - Recruiting

  • Clinical Site

    Quebec City, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Clinical Site

    Sherbrooke, Quebec J1G 1X9
    Canada

    Active - Recruiting

  • Clinical Site

    Berlin, 10789
    Germany

    Active - Recruiting

  • Clinical Site

    Bochum, 44793
    Germany

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  • Clinical Site

    Buxtehude, 21614
    Germany

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  • Clinical Site

    Erlangen, 91054
    Germany

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  • Clinical Site

    Essen, 45147
    Germany

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  • Clinical Site

    Frankfurt, 60590
    Germany

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    Halle/ Saale, 06108
    Germany

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  • Clinical Site

    Hannover, 30159
    Germany

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  • Clinical Site

    Langenau, 89129
    Germany

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    Mahlow, 15831
    Germany

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    Muenchen, 80337
    Germany

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    Münster, 48149
    Germany

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    Oldenburg, 26133
    Germany

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    Wuppertal, 42283
    Germany

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    Budapest, 1036
    Hungary

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    Debrecen, 4031
    Hungary

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    Pécs, 7632
    Hungary

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    Chieti, 66013
    Italy

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    Cona, 44124
    Italy

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    Milano, 20122
    Italy

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    Pisa,
    Italy

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    Rome, 00168
    Italy

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    Rozzano, 20089
    Italy

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    Torrette, 60020
    Italy

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    Oslo, 0372
    Norway

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    Białystok, 15-453
    Poland

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    Gdańsk, 80-214
    Poland

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    Kraków, 30-002
    Poland

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    Lublin, 20-573
    Poland

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    Ossy, 42-624
    Poland

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    Poznań, 60-529
    Poland

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    Sosnowiec, 41-200
    Poland

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    Szczecin, 71-500
    Poland

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    Warsaw, 00-710
    Poland

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    Warszawa, 02-507
    Poland

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    Wrocław, 51-503
    Poland

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    Łódź, 90-265
    Poland

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  • Clinical Site

    Lisboa, 1169-050
    Portugal

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    Lisbon, 1649-035
    Portugal

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  • Clinical Site

    Cardiff, CF14 4XW
    United Kingdom

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    Dudley, DY1 2HQ
    United Kingdom

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    Leeds, LS9 7TF
    United Kingdom

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    Salford, M6 8HD
    United Kingdom

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    Northridge, California 91325
    United States

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    Sacramento, California 95815
    United States

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    San Diego, California 92123
    United States

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    Coral Gables, Florida 33134
    United States

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  • Clinical Site

    Coral Springs, Florida 33071
    United States

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  • Clinical Site

    Hollywood, Florida 33201
    United States

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  • Clinical Site

    Margate, Florida 33063
    United States

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  • Clinical Site

    Miami, Florida 33161
    United States

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  • Clinical Site

    Tampa, Florida 33607
    United States

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    Macon, Georgia 31217
    United States

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    Sandy Springs, Georgia 30328
    United States

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    West Dundee, Illinois 60118
    United States

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    Columbus, Indiana 47201
    United States

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    New Albany, Indiana 47150
    United States

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    Louisville, Kentucky 40241
    United States

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    Metairie, Louisiana 70006
    United States

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    Boston, Massachusetts 02215
    United States

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    Warren, Michigan 48088
    United States

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    Las Vegas, Nevada 89119
    United States

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    Portsmouth, New Hampshire 03801
    United States

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    New York, New York 10012
    United States

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    Boardman, Ohio 44512
    United States

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    Dayton, Ohio 45324
    United States

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    Mayfield Heights, Ohio 44124
    United States

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  • Clinical Site

    Nashville, Tennessee 37215
    United States

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    Frisco, Texas 75034
    United States

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    Houston, Texas 77004
    United States

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    South Jordan, Utah 84095
    United States

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  • Clinical Site

    Lynchburg, Virginia 24501
    United States

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  • Clinical Site

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

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