An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 96 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the long-term safety of ORKA-001 and how well it works for plaque psoriasis, which causes thick, scaly patches on the skin. It is for adults with moderate to severe plaque psoriasis who took part in an earlier study sponsored by Oruka Therapeutics. Everyone in this study knows which treatment they receive.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You successfully finished the earlier study.
- You choose to join this follow-up study and sign a consent form.
- If you can become pregnant, you must have a negative urine pregnancy test at the first visit.
- If you can become pregnant, or are a man who can father a child with a partner who can become pregnant, you must agree to keep using highly effective birth control.
Who can't join
- You had side effects from ORKA-001 in the earlier study that made you stop it for good, or that the study doctor believes make it unsafe to continue.
- During the earlier study, you developed psoriasis with small, drop-shaped spots, widespread redness, pus-filled bumps, or psoriasis caused by a drug.
- You have or had another serious illness, health problem, or exam finding that the study doctor believes could affect your safety or the study results.
- Your latest lab results from the earlier study show a serious problem that the study doctor believes makes it unsafe to continue ORKA-001.
- You are pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (22)
AZ
- Oruka Therapeutics Investigative Site · Phoenix, AZ 85032Oruka Therapeutics Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Phoenix
CA
- Oruka Therapeutics Investigative Site · Fountain Valley, CA 92708Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Fountain Valley
- Oruka Therapeutics Investigative Site · Los Angeles, CA 90045Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Los Angeles
- Oruka Therapeutics Investigative Site · San Diego, CA 92123Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in San Diego
- Oruka Therapeutics Investigative Site · Santa Ana, CA 92701Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Santa Ana
- Oruka Therapeutics Investigative Site · Santa Monica, CA 90403Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Santa Monica
CT
- Oruka Therapeutics Investigative Site · Cromwell, CT 06416Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Cromwell
FL
- Oruka Therapeutics Investigative Site · Miami, FL 33126Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Miami
IL
- Oruka Therapeutics Investigative Site · Rolling Meadows, IL 60008Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Rolling Meadows
KY
- Oruka Therapeutics Investigative Site · Bowling Green, KY 42104Oruka Investigative Site · Study contact · clinicaltrials@orukatx.comMore trials in Bowling Green
MA
- Oruka Therapeutics Investigative Site · Boston, MA 02111Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Boston
MD
- Oruka Therapeutics Investigative Site · Rockville, MD 20850Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Rockville
MI
- Oruka Therapeutics Investigative Site · Detroit, MI 48202Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Detroit
NY
- Oruka Therapeutics Investigative Site · New York, NY 10023Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in New York
- Oruka Therapeutics Investigative Site · New York, NY 10029Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in New York
OH
- Oruka Therapeutics Investigative Site · Mason, OH 45040Oruka Therapeutics Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Mason
OR
- Oruka Therapeutics Investigative Site · Portland, OR 97201Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Portland
- Oruka Therapeutics Investigative Site · Portland, OR 97210Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Portland
TX
- Oruka Therapeutics Investigative Site · Frisco, TX 75033Oruka Therapeutics Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Frisco
- Oruka Therapeutics Investigative Site · Houston, TX 77004Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Houston
- Oruka Therapeutics Investigative Site · Webster, TX 77598Oruka Therapeutics Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Webster
VA
- Oruka Therapeutics Investigative Site · Norfolk, VA 23502Oruka Investigative Site · Study contact · 781-560-0299 · clinicaltrials@orukatx.comMore trials in Norfolk