Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenit… (NCT05322473) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
United States234 participantsStarted 2022-04-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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;