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

NCT07783542 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ORKA-002-214
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blinded, placebo-controlled clinical study of ORKA-002 in adult participants with moderate-to-severe HS.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Phase 2; ORKA-002; Hidradenitis Suppurativa; HS

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (4)

• Proportion of participants achieving HiSCR50 at Week 16

  Week 16

• Change from Baseline in the weekly mean of the Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) worst skin pain score at Week 16

  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

  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

  Day 1 through Week 92

Study Arms (2)

Induction Period - Arm 1 (ORKA-002)

EXPERIMENTAL

Participants will receive ORKA-002 per protocol Induction regimen.

Drug: ORKA-002

Induction Period - Arm 2 (Placebo)

EXPERIMENTAL

Participants will receive Placebo per protocol Induction regimen.

Other: Placebo

Interventions

ORKA-002 DRUG

ORKA-002 administered by subcutaneous (SC) injection

Induction Period - Arm 1 (ORKA-002)

Placebo OTHER

Placebo administered by subcutaneous (SC) injection

Induction Period - Arm 2 (Placebo)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oruka Therapeutics, Inc.: lead

Study Sites (1)

Oruka Therapeutics Investigative Site, Chapel Hill, NC 27516

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Oruka Clinical Trials Information

CONTACT

781-560-0299; clinicaltrials@orukatx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)