ORKA-001 for Plaque Psoriasis
(EVERLAST-A Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, ORKA-001, for individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study compares ORKA-001 with a placebo (a harmless pill resembling the real treatment) to evaluate its effectiveness, safety, and overall impact. Individuals with plaque psoriasis affecting more than 10% of their body, who experience regular flare-ups and are considering advanced treatments, might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that ORKA-001 is likely to be safe for humans?
Research has shown that ORKA-001 is generally well tolerated, with a safety profile similar to other treatments in its group, known as IL-23p19 antibodies. This indicates that its side effects are expected and comparable to those of existing treatments. Earlier studies reported that the most common side effects were mild and typical for this type of treatment. While side effects can occur, they are usually manageable. Overall, the evidence supports the safety of ORKA-001 in humans.12345
Why do researchers think this study treatment might be promising for plaque psoriasis?
Most treatments for plaque psoriasis, like biologics and systemic therapies, aim to suppress the immune system to reduce symptoms. However, ORKA-001 is unique because it targets a specific pathway involved in the inflammation process, potentially offering a more precise approach. Researchers are excited about ORKA-001 because it may provide effective relief with fewer side effects compared to broader immunosuppressants. Additionally, the potential for a novel delivery method could improve patient adherence and convenience.
What evidence suggests that ORKA-001 might be an effective treatment for plaque psoriasis?
Studies have shown that ORKA-001, a new treatment tested in this trial, holds promise for treating moderate-to-severe plaque psoriasis. Research indicates that patients receiving ORKA-001 have shown significant improvements, with some experiencing complete clearance of their psoriasis. The treatment lasts about 100 days, longer than similar treatments like risankizumab, potentially requiring fewer doses. Early trial findings have been positive, demonstrating good results in reducing psoriasis symptoms.12356
Are You a Good Fit for This Trial?
Adults with moderate-to-severe plaque psoriasis can join this trial. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study or pose a risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive ORKA-001 or placebo per protocol Induction regimen
Maintenance
Participants continue with ORKA-001 or placebo based on protocol defined response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- ORKA-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oruka Therapeutics, Inc.
Lead Sponsor