Status:
COMPLETED
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Lead Sponsor:
MoonLake Immunotherapeutics AG
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT05322473
Start Date
April 25 2022
End Date
August 30 2023
Last Update
May 3 2024
Active Locations (57)
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1
Clinical Site
Fountain Valley, California, United States, 92708
2
Clinical Site
Los Angeles, California, United States, 90056
3
Clinical Site
Miami, Florida, United States, 33136
4
Clinical Site
Ormond Beach, Florida, United States, 32127