What this study is
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.
What's being tested
- ORKA-001
Intervention · DRUG
ORKA-001 administered by subcutaneous (SC) injection
Study details
- Official title
- 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
- Sponsor
- Oruka Therapeutics, Inc.
- Conditions
- Plaque Psoriasis
- Enrolling
- 240 people
- Starts
- 2026-02-23
- Est. completion
- 2030-07
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
- 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.
- Participant is pregnant or breastfeeding.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (39)
39 openContact for 30 of 39 open sites
- Oruka Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
Oruka Therapeutics Investigative Site
Phoenix, Arizona, United States
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
North Little Rock, Arkansas, United States
RecruitingOruka Therapeutics Investigative Site
Fountain Valley, California, United States
RecruitingOruka Therapeutics Investigative Site
Los Angeles, California, United States
RecruitingOruka Therapeutics Investigative Site
Los Angeles, California, United States
RecruitingOruka Therapeutics Investigative Site
San Diego, California, United States
RecruitingOruka Therapeutics Investigative Site
Santa Ana, California, United States
RecruitingOruka Therapeutics Investigative Site
Santa Monica, California, United States
RecruitingOruka Therapeutics Investigative Site
Cromwell, Connecticut, United States
RecruitingOruka Therapeutics Investigative Site
Miami, Florida, United States
RecruitingOruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
RecruitingOruka Therapeutics Investigative Site
Plainfield, Indiana, United States
RecruitingOruka Therapeutics Investigative Site
Bowling Green, Kentucky, United States
- Oruka Investigative Site · Contactclinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Rockville, Maryland, United States
RecruitingOruka Therapeutics Investigative Site
Boston, Massachusetts, United States
RecruitingOruka Therapeutics Investigative Site
Detroit, Michigan, United States
RecruitingOruka Therapeutics Investigative Site
New York, New York, United States
RecruitingOruka Therapeutics Investigative Site
New York, New York, United States
RecruitingOruka Therapeutics Investigative Site
Cleveland, Ohio, United States
RecruitingOruka Therapeutics Investigative Site
Mason, Ohio, United States
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Portland, Oregon, United States
RecruitingOruka Therapeutics Investigative Site
Portland, Oregon, United States
RecruitingOruka Therapeutics Investigative Site
Frisco, Texas, United States
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Houston, Texas, United States
RecruitingOruka Therapeutics Investigative Site
Webster, Texas, United States
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Norfolk, Virginia, United States
Recruiting
13 sites outside the US
Oruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
RecruitingOruka Therapeutics Investigative Site
Edmonton, Alberta, Canada
RecruitingOruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
RecruitingOruka Therapeutics Investigative Site
Surrey, British Columbia, Canada
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Fredericton, New Brunswick, Canada
RecruitingOruka Therapeutics Investigative Site
Ajax, Ontario, Canada
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
London, Ontario, Canada
RecruitingOruka Therapeutics Investigative Site
Markham, Ontario, Canada
RecruitingOruka Therapeutics Investigative Site
Peterborough, Ontario, Canada
RecruitingOruka Therapeutics Investigative Site
Toronto, Ontario, Canada
RecruitingOruka Therapeutics Investigative Site
Waterloo, Ontario, Canada
RecruitingOruka Therapeutics Investigative Site
Montreal, Quebec, Canada
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
RecruitingOruka Therapeutics Investigative Site
Québec, Quebec, Canada
- Oruka Therapeutics Investigative Site · Contact781-560-0299clinicaltrials@orukatx.com
Recruiting
Study team
Sponsor
Oruka Therapeutics, Inc.
Study ID ORKA-001-113
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.