NCT07449702RecruitingPhase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- 23 Feb 2026
- Primary completion date
- 31 May 2030
- Lead sponsor
- Oruka Therapeutics, Inc.
- Diseases
- Psoriasis
- NCT number
- NCT07449702
- EU CT number
- 2026-526898-42-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 240
- From 23 Feb 2026 to the primary completion date, 31 May 2030
- 42 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
- Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
Lab values
- Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
Other
- Participant is pregnant or breastfeeding.
Who the study is looking for
- Signed informed consent by participants from previous trial choosing to transition into the OLE.
- Participants who have successfully completed the preceding trial.
- For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
- For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (42)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Ajax | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Fredericton | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Markham | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Peterborough | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Surrey | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Waterloo | Canada | Recruiting |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Not yet recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Not yet recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Not yet recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Icr Medical S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Bowling Green | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Cromwell | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Frisco | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Mason | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | North Little Rock | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Plainfield | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Rolling Meadows | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Oruka Therapeutics Investigative Site Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.