Plaque Psoriasis
Conditions
Keywords
Phase 2, ORKA-001, Plaque psoriasis
Brief summary
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Detailed description
This is a proof-of-concept study evaluating ORKA-001 in patients with moderate-to-severe psoriasis with study drug administration divided into an Induction period followed by a Maintenance period. Following completion of the Maintenance period at Week 52, participants will have the option to enter into the open-label extension (OLE) study.
Interventions
DRUGORKA-001 Induction Dose
ORKA-001 Induction Dose, administered by subcutaneous (SC) injection
OTHERPlacebo
Placebo administered by subcutaneous (SC) injection
DRUGORKA-001 Maintenance Dose
ORKA-001 Maintenance Dose, administered by subcutaneous (SC) injection
Sponsors
Oruka Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants ≥ 18 years of age 2. Have a diagnosis of plaque psoriasis for \> 6 months 3. Have moderate-to-severe chronic plaque psoriasis defined as: 1. BSA ≥ 10%, and 2. PASI ≥ 12, and 3. IGA score of ≥ 3 on a 5-point scale 4. Candidate for systemic therapy or phototherapy 5. Women of childbearing potential must have a negative pregnancy test
Exclusion criteria
1. Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis 2. 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 3. History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence 4. A known hypersensitivity to any components of the ORKA-001 drug product 5. Women who are breastfeeding or plan to breastfeed during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 | Week 16 | The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16 | Week 16 | The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). |
| Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 | Week 16 | Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). |
| Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 | Week 16 | The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). |
| Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 52 | Week 52 | The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). |
| Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 52 | Week 52 | The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). |
| Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 52 | Week 52 | The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease). |
| Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 52 | Week 52 | The Investigator Global Assessment (IGA) documents the Investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). |
| Incidence of Treatment-emergent Adverse Events | Day 1 through 52 Weeks | Incidence of treatment adverse events and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms |
Countries
Canada, United States
Outcome results
None listed