Overview

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

Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MoonLake Immunotherapeutics AG
Treatments:
Adalimumab
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.