Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:50 AM
Study NCT ID:
NCT07474792
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Sponsor:
Oruka Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blinded, Placebo- Controlled, Dose-Range Finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-002 in Participants With Moderate-to-Severe Plaque Psoriasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
Detailed Description:
This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.
The study will consist of 3 periods:
* Screening Period
* Induction Period
* Post-treatment Follow-up Period
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo.
The study will consist of 3 periods:
* Screening Period
* Induction Period
* Post-treatment Follow-up Period
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: