ORKA-001 for Plaque Psoriasis
(EVERLAST-B Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ORKA-001 for individuals with moderate-to-severe plaque psoriasis, a skin condition that causes red, scaly patches. The study aims to evaluate the effectiveness and safety of ORKA-001 by comparing different doses to a placebo (a substance with no active medication). Participants will receive either one of several doses of ORKA-001 or a placebo. Ideal candidates are adults who have had moderate-to-severe plaque psoriasis for more than six months and are considering treatments like systemic therapy or phototherapy. As a Phase 2 trial, this research measures how well ORKA-001 works in an initial, smaller group, offering participants a chance to contribute to the development of a potential new treatment.
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?
Previous studies found that ORKA-001 was well-tolerated by participants at various dose levels. Its safety profile matched that of other drugs in the same class, with common side effects being mild and similar to those of comparable treatments. These findings suggest that ORKA-001 was safe for people in earlier trials. However, all medications can cause side effects, and individual reactions may vary. Always consult a healthcare provider for personalized advice.12345
Why do researchers think this study treatment might be promising?
ORKA-001 is unique because it offers a new approach to treating plaque psoriasis by potentially providing more tailored dosing options. Current treatments often involve biologics or topical agents, but ORKA-001 is being tested in various dosages (37.5 mg, 300 mg, and 600 mg) to find the most effective regimen, which could mean more personalized care. Researchers are excited because this could lead to better management of symptoms with fewer side effects, especially compared to higher doses of traditional treatments. Additionally, having both induction and maintenance phases in the treatment plan could help maintain long-term control of the condition.
What evidence suggests that ORKA-001 could be an effective treatment for plaque psoriasis?
Research shows that ORKA-001, a new treatment for plaque psoriasis, is promising. In earlier studies, ORKA-001 was well-tolerated and had a safety profile similar to other drugs in its category, which block certain proteins involved in the immune system. The drug remains in the body for an extended period, potentially allowing for less frequent dosing. Early trials suggested it could be effective with just one dose a year. These findings are encouraging for people with moderate-to-severe plaque psoriasis, as they suggest ORKA-001 could offer a new, manageable treatment option. Participants in this trial will receive different dosages of ORKA-001 or a placebo to further evaluate its effectiveness and safety.23678
Are You a Good Fit for This Trial?
This trial is for adults with moderate-to-severe plaque psoriasis. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive one of three induction dosing regimens of ORKA-001 or placebo
Maintenance
Participants continue with one of three maintenance regimens of 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
Trial Overview
The trial is testing ORKA-001 at different doses to see how well it works compared to a placebo. It's conducted across multiple centers where patients are randomly assigned to either the drug or placebo without knowing which one they receive (double-blinded).
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.
Participants will receive 600 mg ORKA-001 per protocol Induction regimen.
Participants will receive 300 mg ORKA-001 per protocol Induction regimen.
Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.
Participants will receive Placebo per protocol Induction regimen.
Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oruka Therapeutics, Inc.
Lead Sponsor
Citations
Phase 1 Clinical Data of ORKA-001, a Novel Half-Life ...
ORKA-001 was well-tolerated across all dose levels, with a favorable safety profile consistent with the IL-23p19 inhibitor class. These ...
2.
ir.orukatx.com
ir.orukatx.com/news-releases/news-release-details/oruka-therapeutics-announces-positive-interim-phase-1-resultsOruka Therapeutics Announces Positive Interim Phase 1 ...
PK: ORKA-001 showed a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab ...
Study Details | NCT07090330 | ORKA-001 Versus Placebo ...
This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction ...
4.
orukatx.gcs-web.com
orukatx.gcs-web.com/news-releases/news-release-details/oruka-therapeutics-reports-second-quarter-2025-financial-resultsOruka Therapeutics Reports Second Quarter 2025 Financial ...
The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. Psoriasis trials historically have low placebo ...
ORKA-001 Advances Toward Yearly Dosing
ORKA-001 by Oruka Therapeutics offers promising yearly dosing for psoriasis, showcasing extended efficacy and safety in early clinical trials.
Phase 1 Clinical Data of ORKA-001, a Novel Half-Life ...
ORKA-001 was well-tolerated across all dose levels, with a favorable safety profile consistent with the IL-23p19 inhibitor class. These ...
7.
rarediseaseadvisor.com
rarediseaseadvisor.com/news/il23-pathway-inhibitor-orka-001-promise-plaque-psoriasis/IL-23 Inhibitor ORKA-001 Shows Promise in Plaque Psoriasis
ORKA-001 was well tolerated and had a safety profile consistent with other IL-23p19 antibodies. The most common treatment-emergent adverse ...
Press Releases - Investor Relations | Oruka Therapeutics, Inc.
First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at ...
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