Last reviewed · How we verify
NCT07449702
An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Phase 2 trial testing ORKA-001 in Plaque Psoriasis in 240 participants. Currently enrolling.
1 May 2030
Quick facts
| Lead sponsor | Oruka Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 23 February 2026 |
| Primary completion | 1 May 2030 |
| Estimated completion | 1 July 2030 |
| Sites | 22 locations across United States, Canada |
Drugs / interventions tested
- ORKA-001 — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
Oruka Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
Time frame: Day 1 through Week 144
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
Sponsor's own description
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07449702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ORKA-001
Trials testing the same drug.
- NCT06698939 — ORKA-001 in Healthy Volunteers · Phase 1 · completed
Other recruiting trials for Plaque Psoriasis
Currently open trials in the same condition.
- NCT07357831 — A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psor · Phase 3 · recruiting
- NCT07250802 — A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis · Phase 3 · recruiting
- NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
- NCT07234591 — A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis · NA · recruiting
- NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
Other Oruka Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT06698939 — ORKA-001 in Healthy Volunteers · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07449702 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oruka Therapeutics, Inc.
- Last refreshed: 29 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07449702.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing