Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
{ "Study of ORKA-002 for Moderate-to-Severe Plaque Psoriasis", "This study is testing a new medication called ORKA-002 for people with moderate-to-severe plaque psoriasis. Researchers want to find the best dose of ORKA-002 and see how well it works and if it's safe. You might be able to join if you are between 18 and 79 years old, have had plaque psoriasis for over 6 months, and your psoriasis covers at least 10% of your body. The main goals are to see how many participants achieve clear skin (100% reduction in PASI score) by Week 16 and to track any side effects over 48 weeks. This study is currently looking for participants.", "design": "This is a randomized, double-blinded, placebo-controlled study involving about 160 adults. This means participants will be randomly assigned to receive either ORKA-002 at different doses or a placebo (an inactive substance), and neither you nor your doctor will know which you are receiving.", "commitments": "The study involves a screening period, an induction period where you receive treatment, and a post-treatment follow-up period. ORKA-002 or placebo will be given by injection under the skin.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed for side effects from Day 1 through Week 48.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
At a glance
Conditions
Where it's being run
39 sites across 21 statesWho to contact
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What this trial measures
- Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16Week 16
The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)Day 1 through Week 48
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms