Clinical Trials in the USA / NCT07449702
Recruiting
Phase 2
An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
NCT07449702 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Plaque Psoriasis
Investigational drug(s) / intervention(s)
ORKA-001: ORKA-001 administered by subcutaneous (SC) injection
Study summary
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.
Eligibility
Inclusion Criteria:
1. Signed informed consent by participants from previous trial choosing to transition into the OLE.
2. Participants who have successfully completed the preceding trial.
3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
4. 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
Exclusion Criteria:
1. 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
2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
3. 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.
4. 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.
5. Participant is pregnant or breastfeeding.
Primary outcome measure(s)
- Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) — 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.
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Oruka Therapeutics Investigative Site | Phoenix | Arizona | Recruiting |
| Oruka Therapeutics Investigative Site | North Little Rock | Arkansas | Recruiting |
| Oruka Therapeutics Investigative Site | Fountain Valley | California | Recruiting |
| Oruka Therapeutics Investigative Site | Los Angeles | California | Recruiting |
| Oruka Therapeutics Investigative Site | Los Angeles | California | Recruiting |
| Oruka Therapeutics Investigative Site | San Diego | California | Recruiting |
| Oruka Therapeutics Investigative Site | Santa Ana | California | Recruiting |
| Oruka Therapeutics Investigative Site | Santa Monica | California | Recruiting |
| Oruka Therapeutics Investigative Site | Cromwell | Connecticut | Recruiting |
| Oruka Therapeutics Investigative Site | Miami | Florida | Recruiting |
| Oruka Therapeutics Investigative Site | Rolling Meadows | Illinois | Recruiting |
| Oruka Therapeutics Investigative Site | Plainfield | Indiana | Recruiting |
| Oruka Therapeutics Investigative Site | Bowling Green | Kentucky | Recruiting |
| Oruka Therapeutics Investigative Site | Rockville | Maryland | Recruiting |
| Oruka Therapeutics Investigative Site | Boston | Massachusetts | Recruiting |
| Oruka Therapeutics Investigative Site | Detroit | Michigan | Recruiting |
| Oruka Therapeutics Investigative Site | New York | New York | Recruiting |
| Oruka Therapeutics Investigative Site | New York | New York | Recruiting |
| Oruka Therapeutics Investigative Site | Cleveland | Ohio | Recruiting |
| Oruka Therapeutics Investigative Site | Mason | Ohio | Recruiting |
| Oruka Therapeutics Investigative Site | Portland | Oregon | Recruiting |
| Oruka Therapeutics Investigative Site | Portland | Oregon | Recruiting |
| Oruka Therapeutics Investigative Site | Frisco | Texas | Recruiting |
| Oruka Therapeutics Investigative Site | Houston | Texas | Recruiting |
| Oruka Therapeutics Investigative Site | Webster | Texas | Recruiting |
| Oruka Therapeutics Investigative Site | Norfolk | Virginia | Recruiting |
| Oruka Therapeutics Investigative Site | Edmonton | Alberta | Recruiting |
| Oruka Therapeutics Investigative Site | Edmonton | Alberta | Recruiting |
| Oruka Therapeutics Investigative Site | Surrey | British Columbia | Recruiting |
| Oruka Therapeutics Investigative Site | Surrey | British Columbia | Recruiting |
| Oruka Therapeutics Investigative Site | Fredericton | New Brunswick | Recruiting |
| Oruka Therapeutics Investigative Site | Ajax | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | London | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | Markham | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | Peterborough | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | Toronto | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | Waterloo | Ontario | Recruiting |
| Oruka Therapeutics Investigative Site | Montreal | Quebec | Recruiting |
| Oruka Therapeutics Investigative Site | Québec | Quebec | Recruiting |
More Oruka Therapeutics, Inc. trials in the USA
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Other trials for the same condition
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Active, not recruiting
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07449702 on ClinicalTrials.gov ↗ ← All trials in the USA