Recruiting

Phase 2

ORKA-001An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Sponsor:

Oruka Therapeutics, Inc.

Code:

NCT07449702

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ORKA-001

Study Details

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.

Conditions

Plaque Psoriasis

Study ID

NCT07449702

Start date

Feb 23, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent by participants from previous trial choosing to transition into the OLE.
2. Participants who have successfully completed the preceding trial.
3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
4. 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

Exclusion Criteria:

1. 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
2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
3. 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.
4. 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.
5. Participant is pregnant or breastfeeding.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ORKA-001 Once Yearly (High Dose)

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

experimental: ORKA-001 Once Yearly (Low Dose)

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

experimental: ORKA-001 Twice Yearly

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

no intervention: No Drug

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

Interventions

ORKA-001

ORKA-001 administered by subcutaneous (SC) injection

Primary outcome measure

Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) [ Time Frame: Day 1 through Week 144 ]

Central Contacts and Locations

Central contacts

Oruka Clinical Trials Information

ORKA-001An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information