ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.

The study will evaluate an induction dosing regimen of ORKA-002 administered every 4 weeks for 12 weeks compared with placebo during a double-blind induction period through Week 16. This will be followed by an open-label maintenance period, during which ORKA-002 will be administered every 12 weeks. The study will consist of four periods:

• Screening Period
• Induction Period (double-blind)
• Maintenance Period (open-label)
• Post-Treatment Follow-Up Period

Inclusion Criteria:

1. Has signs and symptoms of HS for at least 6 months;
2. Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III;
3. Has a history of inadequate response to systemic antibiotic treatment for HS, exhibited recurrence of HS symptoms after discontinuation of systemic antibiotics for HS, demonstrated intolerance to systemic antibiotics for HS, or has a contraindication to systemic antibiotics for HS

Exclusion Criteria:

1. Presence of any other active skin disease or condition that may interfere with the assessment of HS;
2. Diagnosis or suspected diagnosis of autoimmune diseases or inflammatory conditions other than HS