Recruiting
Phase 2

ORKA-002

Sponsor:

Oruka Therapeutics, Inc.

Code:

NCT07783542

Conditions

Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ORKA-002

Placebo

Study Details

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)

Study ID

NCT07783542

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Induction Period - Arm 1 (ORKA-002)

Participants will receive ORKA-002 per protocol Induction regimen.

experimental: Induction Period - Arm 2 (Placebo)

Participants will receive Placebo per protocol Induction regimen.

Interventions

ORKA-002

ORKA-002 administered by subcutaneous (SC) injection

Placebo

Placebo administered by subcutaneous (SC) injection

Primary outcome measure

  • Proportion of participants achieving HiSCR75 at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Oruka Clinical Trials Information

781-560-0299clinicaltrials@orukatx.com

Locations

Oruka Therapeutics Investigative Site

Recruiting

Dallas, Texas, United States, 75246

Contacts

More Information

Sponsor

Oruka Therapeutics, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Phase 2
  • ORKA-002
  • Hidradenitis Suppurativa
  • HS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oruka Therapeutics, Inc. on 2026-08-31.