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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

Who can join

Ages 18 to 79 · All sexes

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

About the study

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

What is being tested

• ORKA-002 (drug)
• Placebo (other)

Sponsor: Oruka Therapeutics, Inc. · Participants: 200 · Started: Aug 21, 2026

Contact the study team

• Oruka Clinical Trials Information · Phone: 781-560-0299

Official record on ClinicalTrials.gov — NCT07783542

Locations in the U.S.

Conditions

• Hidradenitis Suppurativa

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.