Hidradenitis Suppurativa (HS)Phase 2NCT07783542
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
A Phase 2 study testing ORKA-002 in people with Hidradenitis Suppurativa (HS), run by Oruka Therapeutics, Inc. at 15 sites in United States.
Trial summary
This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- ORKA-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Aug 2026to Sep 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Oruka Therapeutics Investigative Site
Birmingham, Alabama, 35244
Oruka Investigative Site, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Canton, Michigan, 48187
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Not yet recruiting
Oruka Therapeutics Investigative Site
Chapel Hill, North Carolina, 27516
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Chicago, Illinois, 60602
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Cromwell, Connecticut, 06416
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Dallas, Texas, 75246
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Fountain Valley, California, 92708
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Los Angeles, California, 90045
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Missouri City, Texas, 77459
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
New Brighton, Minnesota, 55112
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
New Orleans, Louisiana, 70115
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Omaha, Nebraska, 68144
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Portland, Oregon, 97201
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
San Antonio, Texas, 78213
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
- Recruiting
Oruka Therapeutics Investigative Site
Sandy Springs, Georgia, 30328
Oruka Investigative Site, 781-560-0299, clinicaltrials@orukatx.com
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- ORKA-002, Placebo
- Keywords
- Phase 2, ORKA-002, Hidradenitis Suppurativa, HS
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKA-002Drug
ORKA-002 administered by subcutaneous (SC) injection
PlaceboOther
Placebo administered by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Induction Period - Arm 1 (ORKA-002) | Experimental | Participants will receive ORKA-002 per protocol Induction regimen. Receives: Drug: ORKA-002 |
| Induction Period - Arm 2 (Placebo) | Experimental | Participants will receive Placebo per protocol Induction regimen. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving HiSCR75 at 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.
Measured: Week 16
Secondary outcomes (4)
Proportion of participants achieving HiSCR50 at Week 16
At least a 50% reduction from Baseline in the total abscess and inflammatory nodule count, with no increase from Baseline in abscess or draining tunnel count
Measured: Week 16
Change from Baseline in the weekly mean of the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain score at Week 16
This endpoint assesses the change from baseline to Week 16 in the average weekly patient-reported worst skin pain score, as recorded daily in the HSSDD.
Measured: Week 16
Proportion of participants with a ≥ 3-point decrease from Baseline in the weekly mean of the HSSDD worst skin pain score at Week 16 among those with a Baseline score ≥ 3
This endpoint assesses the proportion of participants who achieve at least a 3-point reduction in their weekly mean worst skin pain score by Week 16.
Measured: Week 16
Incidence of TEAEs, TESAEs, and TEAESIs and Observed values, potentially clinically important values, and change from baseline in vital signs, laboratory tests, and electrocardiograms
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse events (TESAEs), and TEAEs of Special Interest (TEAESIs); These endpoints assess safety and tolerability of ORKA-002 in participants with moderate-to-severe HS.
Measured: Day 1 through Week 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start21 Aug 2026
- Primary completionOct 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oruka Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783542
- Sponsor's protocol ID
- ORKA-002-214
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided