Comparing 3 approaches for plaque psoriasis
Official title: 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
- Phase 2
- 4 groups
- Sites in Edmonton, Surrey and 8 more cities
- Recruiting
Interventions
- Medication
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
Canadian Sites (11)
11 of 11 recruiting
- Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta
- Recruiting
Oruka Therapeutics Investigative Site
Edmonton, Alberta
- Recruiting
Oruka Therapeutics Investigative Site
Surrey, British Columbia
- Recruiting
Oruka Therapeutics Investigative Site
Ajax, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
London, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
Markham, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
Peterborough, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
Toronto, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
Waterloo, Ontario
- Recruiting
Oruka Therapeutics Investigative Site
Montreal, Quebec
- Recruiting
Oruka Therapeutics Investigative Site
Québec, Quebec
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 visitBaselineYour starting measurements, taken before treatment begins.Read more →.
- +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
- −Participants who experienced any adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would preclude continued treatment with ORKA-001
- −Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
- −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.
- −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.
- −Participant is pregnant or breastfeeding.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A, B and C receive ORKA-001.
Registry label: A: ORKA-001 Once Yearly (High Dose) · B: ORKA-001 Once Yearly (Low Dose) · C: ORKA-001 Twice Yearly
Group D receives no study treatment and is followed for comparison.
Registry label: D: No Drug
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 240 people.
The study is currently expected to finish around July 2030.
The main measurement is taken over: Day 1 through Week 144.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of Treatment-emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (TEAEs), Treatment-emergent Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (TESAEs), and TEAEs of Special Interest (TEAESIs) — measured over Day 1 through Week 144.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07449702 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ORKA-001Drug
ORKA-001 administered by subcutaneous (SC) injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 1 through Week 144.
The study as a whole is currently expected to finish around 2030-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 240 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Edmonton, Alberta, Canada; Surrey, British Columbia, Canada; Ajax, Ontario, Canada; London, Ontario, Canada; Markham, Ontario, Canada; Peterborough, Ontario, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Oruka Therapeutics Investigative Site
Detroit, Michigan, United States
Oruka Therapeutics Investigative Site
New York, New York, United States
Oruka Therapeutics Investigative Site
New York, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.