RecruitingPhase 2

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

CA

CT

FL

IL

KY

MA

MD

MI

NY

OH

OR

TX

VA