Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ORKA-001, Placebo.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Overview
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.
Interventions
- Drug ORKA-001
ORKA-001 administered by subcutaneous (SC) injection - Other Placebo
Placebo administered by subcutaneous (SC) injection
Primary outcome measures
- Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 [Time frame: Week 16]
Secondary outcome measures (9)
- Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16 [Time frame: Week 16]
- Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 [Time frame: Week 16]
- Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 [Time frame: Week 16]
- Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 [Time frame: Week 100]
- Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 [Time frame: Week 100]
- Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 [Time frame: Week 100]
- Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 [Time frame: Week 100]
- Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 [Time frame: Week 100]
- Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs) [Time frame: Day 1 through Week 100]
Eligibility criteria
Inclusion criteria
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for > 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- BSA ≥ 10%, and
- PASI ≥ 12, and
- IGA score of ≥ 3 on a 5-point scale
- Candidate for systemic therapy or phototherapy
- Women of childbearing potential must have a negative pregnancy test.
Exclusion criteria
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- A known hypersensitivity to any components of the ORKA-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Oruka Therapeutics Investigative Site — Phoenix
- Oruka Therapeutics Investigative Site — North Little Rock
- Oruka Therapeutics Investigative Site — Los Angeles
- Oruka Therapeutics Investigative Site — Los Angeles
- Oruka Therapeutics Investigative Site — San Diego
- Oruka Therapeutics Investigative Site — Miami
- Oruka Therapeutics Investigative Site — Rolling Meadows
- Oruka Therapeutics Investigative Site — Plainfield
- … and 12 more centers
Canada · 8 centers
- Oruka Therapeutics Investigative Site — Surrey
- Oruka Therapeutics Investigative Site — Surrey
- Oruka Therapeutics Investigative Site — Fredericton
- Oruka Therapeutics Investigative Site — Ajax
- Oruka Therapeutics Investigative Site — Markham
- Oruka Therapeutics Investigative Site — Peterborough
- Oruka Therapeutics Investigative Site — Montreal
- Oruka Therapeutics Investigative Site — Québec
Germany · 4 centers
- Oruka Therapeutics Investigative Site — Heidelberg
- Oruka Therapeutics Investigative Site — Frankfurt am Main
- Oruka Therapeutics Investigative Site — Bad Bentheim
- Oruka Therapeutics Investigative Site — Kiel
Spain · 4 centers
- Oruka Therapeutics Investigative Site — Badalona
- Oruka Therapeutics Investigative Site — Barcelona
- Oruka Therapeutics Investigative Site — Madrid
- Oruka Therapeutics Investigative Site — Madrid
Identifiers
NCT: NCT07290569 · ORKA-001-114