NCT07783542From ClinicalTrials.govRecruiting

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

Hidradenitis Suppurativa (HS)

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Oruka Therapeutics, Inc.
Enrolment target: 200
Started: 21 August 2026
Main results due: October 2028
Study sites: 15
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 79 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(15)

Oruka Therapeutics Investigative Site
Birmingham, Alabama, United States
Recruiting
Oruka Therapeutics Investigative Site
Fountain Valley, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Recruiting
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, United States
Recruiting
Oruka Therapeutics Investigative Site
Sandy Springs, Georgia, United States
Recruiting
Oruka Therapeutics Investigative Site
Chicago, Illinois, United States
Recruiting
Oruka Therapeutics Investigative Site
New Orleans, Louisiana, United States
Recruiting
Oruka Therapeutics Investigative Site
Canton, Michigan, United States
Recruiting
Oruka Therapeutics Investigative Site
New Brighton, Minnesota, United States
Recruiting
Oruka Therapeutics Investigative Site
Omaha, Nebraska, United States
Recruiting
Oruka Therapeutics Investigative Site
Chapel Hill, North Carolina, United States
Not yet recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Recruiting
Oruka Therapeutics Investigative Site
Dallas, Texas, United States
Recruiting
Oruka Therapeutics Investigative Site
Missouri City, Texas, United States
Recruiting
Oruka Therapeutics Investigative Site
San Antonio, Texas, United States
Recruiting

Showing 15 of 15 sites. 14 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07783542. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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