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NCT07474792
Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Conditions: Plaque Psoriasis
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 160
Sponsor: Oruka Therapeutics, Inc.
Location: Oruka Therapeutics Investigative Site Birmingham Alabama
Summary
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
Inclusion Criteria:
1. Participants ≥ 18 and \< 80 years of age at the time of consent
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-002 drug product
5. Women who are breastfeeding or plan to breastfeed during the study
Source: ClinicalTrials.gov (NCT07474792). StuddyBuddy aggregates publicly available trial information.