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Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

NCT05322473

CompletedPhase 2

Sponsor: MoonLake Immunotherapeutics AG

Conditions: Hidradenitis Suppurativa

Interventions: Sonelokimab (M1095), Adalimumab, Placebo

Countries: United States, Bulgaria, Canada, Germany, Ireland, Netherlands, Poland

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Participant is ≥18 years of age;
2. Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit;
3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
4. Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III);
5. Participant 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;
6. Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion Criteria:

1. Participants with known hypersensitivity to sonelokimab or any of its excipients;
2. Participants with known hypersensitivity to adalimumab or any of its excipients;
3. Participant has a draining fistula count of ≥20 at the Screening Visit;
4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
5. Prior exposure to more than 2 biologic response modifiers;
6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.
Locations (57)
  • Fountain Valley, California, United States
  • Los Angeles, California, United States
  • Miami, Florida, United States
  • Ormond Beach, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Indianapolis, Indiana, United States
  • Beverly, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Nashville, Tennessee, United States
  • Bellaire, Texas, United States
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Stara Zagora, Bulgaria
  • Calgary, Alberta, Canada
  • Winnipeg, Manitoba, Canada
  • Fredericton, New Brunswick, Canada
  • St. John's, Newfoundland and Labrador, Canada
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Markham, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Peterborough, Ontario, Canada
  • Saskatoon, Saskatchewan, Canada
  • Bad Bentheim, Germany
  • + 27 more on CT.gov