A Phase 2 interventional study of ORKA-002 and Placebo in Hidradenitis Suppurativa (HS), sponsored by Oruka Therapeutics, Inc.. Recruiting at 25 sites in 2 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Oruka Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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:
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 200 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Oruka Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ORKA-002 per protocol Induction regimen.
Drug: ORKA-002
Participants will receive Placebo per protocol Induction regimen.
Other: Placebo
ORKA-002 administered by subcutaneous (SC) injection
Placebo administered by subcutaneous (SC) injection
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.
Time frame: Week 16
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through Week 92
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Oct 2028, 26 months after the start.
Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 26 months is above that.
Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: ORKA-002
Oruka Therapeutics, Inc.