ORKA-001 for Moderate-to-Severe Plaque Psoriasis
This study is testing a new medication called ORKA-001 for adults with moderate-to-severe plaque psoriasis. Researchers want to find the best dose of ORKA-001 and see how safe and effective it is compared to a placebo (an inactive substance). You might be able to join if you are at least 18 years old, have had plaque psoriasis for over 6 months, and your psoriasis covers at least 10% of your body, with a PASI score (Psoriasis Area and Severity Index) of 12 or higher, and an IGA score (Investigator's Global Assessment) of 3 or higher. The main goal is to see how many participants achieve a 100% reduction in their PASI score after 16 weeks. The study is currently recruiting about 160 participants, but its status is unclear.
- Study design
- This is a randomized, double-blinded, placebo-controlled study involving about 160 participants. It aims to find the best dose of ORKA-001 for plaque psoriasis.
- What's involved
- The study involves a screening period of up to 6 weeks, an induction period of up to 28 weeks, and a maintenance period of up to 72 weeks. You will receive ORKA-001 or a placebo by subcutaneous (under the skin) injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants who do not enter an open-label extension study will be followed for 48 weeks after their last treatment or early withdrawal.
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-001 in Patients With Moderate-to-Severe Plaque Psoriasis
At a glance
Conditions
Where it's being run
36 sites across 24 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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).