Brief Summary

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

240

participants targeted

Target at P75+ for phase_2

Timeline

48mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach

2 countries

24 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.4 years study duration

Study Progress10%

Feb 2026Jul 2030

Study Start

First participant enrolled

February 23, 2026

Completed

3 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4.2 years

First QC Date

February 26, 2026

Last Update Submit

June 30, 2026

Conditions

Plaque Psoriasis

Keywords

Phase 2ORKA-001Open Label ExtensionOLE

Outcome Measures

Primary Outcomes (1)

Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)
Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.
Day 1 through Week 144

Secondary Outcomes (9)

Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE
Day 1 through Week 96
Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE
Day 1 through Week 96
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE
Day 1 through Week 96
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE
Time Frame: Day 1 through Week 96
Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline
Day 1 through Week 96
+4 more secondary outcomes

Study Arms (4)

ORKA-001 Once Yearly (High Dose)

EXPERIMENTAL

Participants will receive ORKA-001 once a year per OLE protocol.

Drug: ORKA-001

ORKA-001 Once Yearly (Low Dose)

EXPERIMENTAL

Participants will receive ORKA-001 once a year per OLE protocol.

Drug: ORKA-001

ORKA-001 Twice Yearly

EXPERIMENTAL

Participants will receive ORKA-001 every 6 months per OLE protocol.

Drug: ORKA-001

No Drug

NO INTERVENTION

Participants will receive no drug until protocol defined PASI response criterion is met.

Interventions

ORKA-001DRUG

ORKA-001 administered by subcutaneous (SC) injection

ORKA-001 Once Yearly (High Dose)ORKA-001 Once Yearly (Low Dose)ORKA-001 Twice Yearly

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed informed consent by participants from previous trial choosing to transition into the OLE.
Participants who have successfully completed the preceding trial.
For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception

You may not qualify if:

Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
Participant is pregnant or breastfeeding.

Contact the study team to confirm eligibility.