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Recruiting Phase 2 NCT07449702

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Phase 2 – studying effectiveness and dosage
Conditions: Plaque Psoriasis

Sponsor: Oruka Therapeutics, Inc.

trial.available_in: БГ
Overview
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.
Description
This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.
Who can participate
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, 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.
Interventions
ORKA-001
DRUG
Locations 17
Canada (5)
Oruka Therapeutics Investigative Site
London , Ontario
Oruka Therapeutics Investigative Site
Markham , Ontario
Oruka Therapeutics Investigative Site
Peterborough , Ontario
Oruka Therapeutics Investigative Site
Surrey , British Columbia
Oruka Therapeutics Investigative Site
Toronto , Ontario
United States (12)
Oruka Therapeutics Investigative Site
Bowling Green , Kentucky
Oruka Investigative Site
Oruka Therapeutics Investigative Site
Coral Gables , Florida
Oruka Therapeutics Investigative Site
Cromwell , Connecticut
Oruka Therapeutics Investigative Site
Detroit , Michigan
Oruka Therapeutics Investigative Site
Los Angeles , California
Oruka Therapeutics Investigative Site
New York , New York
Oruka Therapeutics Investigative Site
New York , New York
Oruka Therapeutics Investigative Site
Portland , Oregon
Oruka Therapeutics Investigative Site
Rockville , Maryland
Oruka Therapeutics Investigative Site
San Diego , California
Oruka Therapeutics Investigative Site
Santa Ana , California
Oruka Therapeutics Investigative Site
Santa Monica , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.02.2026
Completion date
01.01.2029
Registry ID
NCT07449702
Source
clinicaltrials.gov
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