Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
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-001 in adult participants with moderate-to-severe plaque psoriasis.
Eligibility criteria
Qualifiers
Participants ≥ 18 years of age
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-001 drug product
Trial design
Treatments tested in this trial
- ORKA-001
- Placebo
Treatment groups
160 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
36Canada
Oruka Therapeutics Investigative SiteV3R 6A7, SurreyBritish Columbia, Canada
Oruka Therapeutics Investigative SiteV3V 0C6, SurreyBritish Columbia, Canada
Oruka Therapeutics Investigative SiteE3B 1G9, FrederictonNew Brunswick, Canada
Oruka Therapeutics Investigative SiteL1S 7K8, AjaxOntario, Canada
Sponsors and collaborators
Oruka Therapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov