NCT07783542 · Oruka Therapeutics, Inc.
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
What this study is about
This is a conducted at multiple hospitals, randomly assigned, double-blinded, compared against an inactive treatment clinical study of ORKA-002 in adult participants with moderate-to-severe HS.
View original scientific description
This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.
Interventions
DRUG
ORKA-002
ORKA-002 administered by subcutaneous (SC) injection
OTHER
Placebo
Placebo administered by subcutaneous (SC) injection
Primary outcome measures
Proportion of participants achieving HiSCR75 at Week 16
Time frame: Week 16
At least a 75% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Has signs and symptoms of HS for at least 6 months;
- Has HS lesions present in ≥ 2 distinct anatomic areas, one of which must be at least Hurley Stage II or III;
- 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
- Presence of any other active skin disease or condition that may interfere with the assessment of HS;
- Diagnosis or suspected diagnosis of autoimmune diseases or inflammatory conditions other than HS
Where
- Birmingham, Alabama
- Fountain Valley, California
- Los Angeles, California
- Cromwell, Connecticut
- Sandy Springs, Georgia
- Chicago, Illinois
- New Orleans, Louisiana
- Canton, Michigan
- New Brighton, Minnesota
- Omaha, Nebraska
- Chapel Hill, North Carolina
- Portland, Oregon
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations