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.

NCT07290569

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Oruka Therapeutics, Inc.
~160 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:ORKA-001Placebo

At a glance

Recruiting sites
0 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16
Measured over Week 16
Plaque Psoriasis
36 sites across 24 states
California3
Texas3
Ontario3
Ohio2
Oregon2
British Columbia2
Quebec2
Barcelona2

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • 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).