An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Purpose
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.
Condition
- Plaque Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ORKA-001 Once Yearly |
Participants will receive ORKA-001 once a year per OLE protocol. |
|
|
Experimental ORKA-001 Twice Yearly |
Participants will receive ORKA-001 every 6 months per OLE protocol. |
|
|
No Intervention No Drug |
Participants will receive no drug until protocol defined PASI response criterion is met. |
|
Recruiting Locations
Oruka Therapeutics Investigative Site
Los Angeles, California 90045
Los Angeles, California 90045
Oruka Therapeutics Investigative Site
San Diego, California 92123
San Diego, California 92123
Oruka Therapeutics Investigative Site
Santa Ana, California 92701
Santa Ana, California 92701
Oruka Therapeutics Investigative Site
Santa Monica, California 90404
Santa Monica, California 90404
Oruka Therapeutics Investigative Site
Cromwell, Connecticut 06416
Cromwell, Connecticut 06416
Oruka Therapeutics Investigative Site
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Oruka Therapeutics Investigative Site
Bowling Green, Kentucky 42104
Bowling Green, Kentucky 42104
Oruka Therapeutics Investigative Site
Rockville, Maryland 20850
Rockville, Maryland 20850
Oruka Therapeutics Investigative Site
Detroit, Michigan 48202
Detroit, Michigan 48202
Oruka Therapeutics Investigative Site
New York, New York 10023
New York, New York 10023
Oruka Therapeutics Investigative Site
New York, New York 10029
New York, New York 10029
Oruka Therapeutics Investigative Site
Portland, Oregon 97201
Portland, Oregon 97201
More Details
- Status
- Recruiting
- Sponsor
- Oruka Therapeutics, Inc.
Detailed 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.