Recruiting

Phase 2

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

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 21, 2026

Status verified date

Sep, 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

781-560-0299 clinicaltrials@orukatx.com

Locations

Oruka Therapeutics Investigative Site

Recruiting

Birmingham, Alabama, United States, 35244

Contacts

Oruka Investigative Site

clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Los Angeles, California, United States, 90045

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Cromwell, Connecticut, United States, 06416

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Sandy Springs, Georgia, United States, 30328

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Chicago, Illinois, United States, 60602

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Canton, Michigan, United States, 48187

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

New Brighton, Minnesota, United States, 55112

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Portland, Oregon, United States, 97201

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Dallas, Texas, United States, 75246

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

Missouri City, Texas, United States, 77459

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

Oruka Therapeutics Investigative Site

Recruiting

San Antonio, Texas, United States, 78213

Contacts

Oruka Investigative Site

781-560-0299 clinicaltrials@orukatx.com

More Information

Sponsor

Oruka Therapeutics, Inc.

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

Phase 2
ORKA-002
Hidradenitis Suppurativa
HS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Oruka Therapeutics, Inc. on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.