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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT05322473

Run by

MoonLake Immunotherapeutics AG

People needed

234

Starts

2022-04-25

Expected to finish

2023-08-30

Last updated by the study team

2024-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is ≥18 years of age;
• 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;
• Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5;
• 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);
• 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;
• 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.

You may not qualify if…

• Participants with known hypersensitivity to sonelokimab or any of its excipients;
• Participants with known hypersensitivity to adalimumab or any of its excipients;
• Participant has a draining fistula count of ≥20 at the Screening Visit;
• Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa;
• Prior exposure to more than 2 biologic response modifiers;
• Participant has a diagnosis of ulcerative colitis or Crohn's disease.

Where it is running

• Clinical Site — Fountain Valley, California, United States
• Clinical Site — Los Angeles, California, United States
• Clinical Site — Miami, Florida, United States
• Clinical Site — Ormond Beach, Florida, United States
• Clinical Site — Tampa, Florida, United States
• Clinical Site — Indianapolis, Indiana, United States
• Clinical Site — Beverly, Massachusetts, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — Omaha, Nebraska, United States
• Clinical Site — New York, New York, United States
• Clinical Site — Philadelphia, Pennsylvania, United States
• Clinical Site — Charleston, South Carolina, United States
• Clinical Site — Nashville, Tennessee, United States
• Clinical Site — Bellaire, Texas, United States
• Clinical Site — Sofia, Bulgaria
• Clinical Site — Sofia, Bulgaria
• Clinical Site — Sofia, Bulgaria
• Clinical Site — Stara Zagora, Bulgaria
• Clinical Site — Calgary, Alberta, Canada
• Clinical Site — Winnipeg, Manitoba, Canada
• Clinical Site — Fredericton, New Brunswick, Canada
• Clinical Site — St. John's, Newfoundland and Labrador, Canada
• Clinical Site — Hamilton, Ontario, Canada
• Clinical Site — London, Ontario, Canada
• Clinical Site — St. Petersburg, Florida, United States

Full record on ClinicalTrials.gov

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