Ignite Creation Date:
2025-12-23 @ 10:28 PM
Ignite Modification Date:
2025-12-23 @ 10:28 PM
Study NCT ID:
NCT07290569
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Ranging Study of ORKA-001 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 of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Status:
RECRUITING
Status Verified Date:
2025-12
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:
EVERLAST-B
Brief Summary:
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Detailed Description:
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 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-001 compared to placebo and will include 3 maintenance regimens.
The study will consist of 4 periods:
* Screening Period of up to 6 weeks
* Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28)
* Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100)
* Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens.
The study will consist of 4 periods:
* Screening Period of up to 6 weeks
* Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28)
* Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100)
* Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
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?: