ORKA-002 versus placebo for moderate-to-severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial evaluating ORKA-002 in adults with moderate-to-severe hidradenitis suppurativa (HS). Participants receive induction dosing every 4 weeks for 12 weeks (double-blind) and then switch to an open-label maintenance period with dosing every 12 weeks. The trial includes screening, induction, maintenance, and post-treatment follow-up phases. Primary comparison is ORKA-002 versus placebo during the induction period, followed by an open-label maintenance phase to assess longer-term effects and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Oruka Therapeutics Investigative Site
  Birmingham, Alabama, United States Recruiting
• Oruka Therapeutics Investigative Site
  Fountain Valley, California, United States Recruiting
• Oruka Therapeutics Investigative Site
  Los Angeles, California, United States Recruiting
• Oruka Therapeutics Investigative Site
  Cromwell, Connecticut, United States Recruiting
• Oruka Therapeutics Investigative Site
  Sandy Springs, Georgia, United States Recruiting
• Oruka Therapeutics Investigative Site
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Oruka Clinical Trials Information
• Email: clinicaltrials@orukatx.com
• Phone: 781-560-0299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Soquelitinib in adults with hidradenitis suppurativa

  This study tests whether oral soquelitinib can help adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting at 9 sites Phase 1 Corvus Pharmaceuticals, Inc. · West Lafayette, Indiana and 10 other locations · NCT07828860

• SPY072 in adults with moderate to severe hidradenitis suppurativa

  This study tests whether SPY072 can help adults with moderate to severe hidradenitis suppurativa when added to their current care, compared with a placebo over 16 weeks.

  Recruiting at 7 sites Phase 2 Spyre Therapeutics, Inc. · Birmingham, Alabama and 33 other locations · NCT07766005

• Brain activity patterns in people with hidradenitis suppurativa and how treatments may relate to changes

  This study tests whether adults with hidradenitis suppurativa show different resting brain activity than healthy people and whether these brain patterns relate to symptoms like pain and mood, and whether they change after 3 months of standard biologic or small-molecule treatment.

  Recruiting Second Xiangya Hospital of Central South University · Changsha, Hunan · NCT07755670

• Roflumilast 0.3% Foam for Hidradenitis Suppurativa in Teens and Adults

  This study tests a topical roflumilast foam to see if it improves HS in adolescents and adults over 16 weeks.

  Recruiting Phase 2 Harrison Dermatology · Missouri City, Texas · NCT07689188

• Global health study on hidradenitis suppurativa

  This study tests how people with hidradenitis suppurativa access care and what treatments they receive across different health systems.

  Recruiting University of Zurich · Zurich · NCT07659769

• Secukinumab in Chinese adults with moderate to severe hidradenitis suppurativa

  This trial tests two dosing regimens of secukinumab to see if they can help Chinese adults with moderate to severe hidradenitis suppurativa.

  Recruiting at 10 sites Phase 4 Novartis · Guangzhou, Guangdong and 9 other locations · NCT07489573

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.