Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis (NCT07474792) | Clinical Trial Compass
RecruitingPhase 2
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
United States, Canada160 participantsStarted 2026-03-19
Plain-language summary
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants ≥ 18 and \< 80 years of age at the time of consent
. Have a diagnosis of plaque psoriasis for \> 6 months
. Have moderate-to-severe chronic plaque psoriasis defined as:
. BSA ≥ 10%, and
. PASI ≥ 12, and
. IGA score of ≥ 3 on a 5-point scale
. Candidate for systemic therapy or phototherapy
. Women of childbearing potential must have a negative pregnancy test
Exclusion criteria
. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis)
. Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
Timeframe: Week 16
2
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)