Plaque Psoriasis study: ORKA-001
Official title An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
ClinicalTrials.gov ID: NCT07449702
What this study is testing
What is ORKA-001?
ORKA-001 is an investigational once‑daily subcutaneous injection being studied for moderate‑to‑severe plaque psoriasis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and effective ORKA‑001 is over a longer period of time.
- Who it's for
- Adults who had moderate‑to‑severe plaque psoriasis and took part in a previous Oruka Therapeutics study.
- What's involved
- Participants will receive ORKA‑001 and have regular visits and tests to monitor safety and skin improvement.
- Time commitment
- The study lasts for an extended period, with scheduled visits to track safety and effectiveness.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product...
- Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the...
- Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination...
- Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the...
- Participant is pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- North Little Rock, Arkansas, United States
- Fountain Valley, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Santa Ana, California, United States
- Santa Monica, California, United States
- Cromwell, Connecticut, United States
- Miami, Florida, United States
- Rolling Meadows, Illinois, United States
- Plainfield, Indiana, United States
- Bowling Green, Kentucky, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Mason, Ohio, United States
- Portland, Oregon, United States
- Frisco, Texas, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; North Little Rock, Arkansas, United States; Fountain Valley, California, United States; Los Angeles, California, United States; San Diego, California, United States; Santa Ana, California, United States and 28 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.