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 15, 2025
Sponsor: MoonLake Immunotherapeutics AG
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Acne Inversa

Hidradenitis Suppurativa

Treatment

Placebo

Sonelokimab

Clinical Study ID

NCT06411379
M1095-HS-302
VELA-2
  • 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: Placebo
Phase: 3
Study Start date:
May 14, 2024
Estimated Completion Date:
June 17, 2026

Connect with a study center

  • Clinical Site

    Gent, 9000
    Belgium

    Active - Recruiting

  • Clinical Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Clinical Site

    Liège, 4000
    Belgium

    Active - Recruiting

  • Clinical Site

    Woluwe-Saint-Lambert, 1200
    Belgium

    Active - Recruiting

  • Clinical Site

    Sofia, 1606
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Stara Zagora, 6003
    Bulgaria

    Active - Recruiting

  • Clinical Site

    Calgary, Alberta T3E 0B2
    Canada

    Active - Recruiting

  • Clinical Site

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • Clinical Site

    Guelph, Ontario N1L 0B7
    Canada

    Active - Recruiting

  • Clinical Site

    Peterborough, Ontario K9J 5K2
    Canada

    Active - Recruiting

  • Clinical Site

    Richmond Hill, Ontario L4B 1A5
    Canada

    Active - Recruiting

  • Clinical Site

    Toronto, Ontario M4E 1R7
    Canada

    Active - Recruiting

  • Clinical Site

    Windsor, Ontario N8W 1E6
    Canada

    Active - Recruiting

  • Clinical Site

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Active - Recruiting

  • Clinical Site

    Ostrava, 708 52
    Czechia

    Active - Recruiting

  • Clinical Site

    Prague, 110 00
    Czechia

    Active - Recruiting

  • Clinical Site

    Antony, 92160
    France

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  • Clinical Site

    Besançon, 25030
    France

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  • Clinical SIte

    Brest, 29200
    France

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  • Clinical Site

    Dijon, 21000
    France

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  • Clinical Site

    Le Mans, 72037
    France

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  • Clinical Site

    Lyon, 69003
    France

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  • Clinical Site

    Montpellier, 34295
    France

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  • Clinical Site

    Rouen, 76031
    France

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  • Clinical Site

    Saint-Priest-en-Jarez, 42270
    France

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  • Clinical Site

    Toulouse, 31400
    France

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  • Clinical Site

    Bad Bentheim, 48455
    Germany

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    Berlin, 10117
    Germany

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  • Clinical Site

    Bielefeld, 33647
    Germany

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  • Clinical Site

    Bochum, 44791
    Germany

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  • Clinical Site

    Bramsche, 49565
    Germany

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    Darmstadt, 64283
    Germany

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  • Clinical Site

    Dresden, 01307
    Germany

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  • Clinical Site

    Gera, 07548
    Germany

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  • Clinical Site

    Hamburg, 20246
    Germany

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  • Clinical Site

    Kiel, 24105
    Germany

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    Luebeck, 23538
    Germany

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    Würzburg, 97080
    Germany

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  • Clinical Site

    Rotterdam, 3015 GD
    Netherlands

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    Chorzów, 41-500
    Poland

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    Katowice, 40-611
    Poland

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  • Clinical Site

    Kielce, 25-316
    Poland

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  • Clinical Site

    Poznań, 61-731
    Poland

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  • Clinical Site

    Szczecin, 70-332
    Poland

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    Warszawa, 02-953
    Poland

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  • Clinical Site

    Wrocław, 50566
    Poland

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  • Clinical Site

    Alcorcón, 28922
    Spain

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  • Clinical Site

    Alicante, 03010
    Spain

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  • Clinical Site

    Badalona, 08916
    Spain

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  • Clinical Site

    Barcelona, 08003
    Spain

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  • Clinical Site

    Cadiz, 11009
    Spain

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  • Clinical Site

    Córdoba, 14004
    Spain

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  • Clinical Site

    Granada, 18014
    Spain

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  • Clinical Site

    Granollers, 08402
    Spain

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  • Clinical Site

    Madrid, 28046
    Spain

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  • Clinical Site

    Manises, 46940
    Spain

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  • Clinical Site

    Santiago De Compostela, 15706
    Spain

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  • Clinical Site

    Sevilla, 41009
    Spain

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  • Clinical Site

    Valencia, 46026
    Spain

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  • Clinical Site

    Birmingham, Alabama 35244
    United States

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  • Clinical Site

    North Little Rock, Arkansas 72117
    United States

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  • Clinical Site

    Fountain Valley, California 92708
    United States

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  • Clinical Site

    Santa Monica, California 90404
    United States

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  • Clinical Site

    Aventura, Florida 33180
    United States

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  • Clinical Site

    Hialeah, Florida 33012
    United States

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  • Clinical Site

    Miami, Florida 33136
    United States

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    Ocala, Florida 34471
    United States

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    Tampa, Florida 33613
    United States

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  • Clinical Site

    Skokie, Illinois 60077
    United States

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    Plainfield, Indiana 46168
    United States

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  • Clinical Site

    Murray, Kentucky 42071
    United States

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  • Clinical Site

    Baton Rouge, Louisiana 70808
    United States

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  • Clinical Site

    Ann Arbor, Michigan 48109-5314
    United States

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    Canton, Michigan 48187
    United States

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  • Clinical Site

    Clarkston, Michigan 48346
    United States

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    Waterford, Michigan 48328
    United States

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    New Brighton, Minnesota 55112
    United States

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    Omaha, Nebraska 68144
    United States

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    Las Vegas, Nevada 89148
    United States

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    New York, New York 10003
    United States

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  • Clinical Site

    Fargo, North Dakota 58103
    United States

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  • Clinical Site

    Columbus, Ohio 43213
    United States

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  • Clinical Site

    Murfreesboro, Tennessee 37130
    United States

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    Dallas, Texas 75390-8565
    United States

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  • Clinical Site

    Plano, Texas 75025
    United States

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  • Clinical Site

    San Antonio, Texas 78213
    United States

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  • Clinical Site

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

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