Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.