Hidradenitis Suppurativa (HS)
Conditions
Keywords
Phase 2, ORKA-002, Hidradenitis Suppurativa, HS
Brief summary
This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.
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
Interventions
DRUGORKA-002
ORKA-002 administered by subcutaneous (SC) injection
OTHERPlacebo
Placebo administered by subcutaneous (SC) injection
Sponsors
Oruka Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving HiSCR75 at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 16 | 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. |
| Proportion of participants achieving HiSCR50 at Week 16 | 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 |
| Change from Baseline in the weekly mean of the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain score at Week 16 | 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. |
| Incidence of TEAEs, TESAEs, and TEAESIs and Observed values, potentially clinically important values, and change from baseline in vital signs, laboratory tests, and electrocardiograms | Day 1 through Week 92 | 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. |
Countries
United States
Contacts
CONTACTOruka Clinical Trials Information
Outcome results
None listed