Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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

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