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

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ORKA-001 — DRUG
  ORKA-001 administered by subcutaneous (SC) injection

Study Details

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.

Key Dates

Start date

Feb 23, 2026

Status verified

May 2026

Primary completion

May 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

240 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Oruka Clinical Trials Information
  781-560-0299
  [email protected]

Locations (16)

Find similar trials in Fountain Valley, CA

Related Studies

• Understanding Participation Habits Among Plaque Psoriasis Patients
  Not Yet Recruiting · Power Life Sciences Inc. · San Francisco, California
• A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama
• A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
  PHASE1 · Recruiting · Ascletis Pharma (China) Co., Limited · Miami, Florida
• Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama