ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa

Phase 2RecruitingNCT07783542

Oruka Therapeutics, Inc.200 enrolled

Overview

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: * Screening Period * Induction Period (double-blind) * Maintenance Period (open-label) * Post-Treatment Follow-Up Period

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Hidradenitis Suppurativa (HS)

Interventions

ORKA-002DRUG

ORKA-002 administered by subcutaneous (SC) injection

PlaceboOTHER

Placebo administered by subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (2)

Oruka Therapeutics Investigative Site

Chapel Hill, North Carolina, United States

NOT_YET_RECRUITING

Oruka Therapeutics Investigative Site

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Oruka Clinical Trials Information

CONTACT

781-560-0299 clinicaltrials@orukatx.com

Data from ClinicalTrials.gov

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