Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorOruka Therapeutics, Inc.
About this trial
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-002 in adult participants with moderate-to-severe plaque psoriasis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants ≥ 18 and < 80 years of age at the time of consent
Have a diagnosis of plaque psoriasis for > 6 months
BSA ≥ 10%, and
PASI ≥ 12, and
Disqualifiers
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-002 drug product
Trial design
Design model
Parallel
Treatments tested in this trial
ORKA-002
DrugORKA-002 administered by subcutaneous (SC) injection
Placebo
Other interventionPlacebo administered by subcutaneous (SC) injection
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: (Induction Period - Arm 1) ORKA-002Experimental treatment 1 intervention
Group B: (Induction Period - Arm 2) ORKA-002Experimental treatment 1 intervention
Group C: (Induction Period - Arm 3) ORKA-002Experimental treatment 1 intervention
Group D: (Induction Period - Arm 4) PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Achieving 100% Reduction in PASI Score at 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).
Time frame
Week 162
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of of Special Interest (TEAESIs)
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Time frame
Day 1 through Week 48Secondary outcomes
1
Proportion of Participants Who Achieve an IGA = 0 (Clear) at 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).
Time frame
Week 162
Proportion of Participants Achieving 90% Reduction in PASI Score at 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).
Time frame
Week 163
Proportion of Participants Who Achieve an IGA=0 (Clear) or 1 (Almost Clear) at 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).
Time frame
Week 164
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse events (TEAEs) and TEAEs of Special Interest (TEAESIs)
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TEAEs), and treatment-emergent adverse events of special interest (TEASIs), and clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms
Time frame
Day 1 through Week 48Sponsors and contacts
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Source ClinicalTrials.gov