Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Folliculitis, Apocrine Gland Disease, Acne Inversa
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
- Clinical Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Active Comparator
sonelokimab dose 1
sonelokimab dose 2
Placebo
adalimumab
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.