Dysautonomia International

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

Purpose

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.

Condition

Plaque Psoriasis

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental (Induction Period - Arm 1) ORKA-001	Participants will receive 37.5 mg ORKA-001 per protocol Induction regimen.	Drug: ORKA-001 ORKA-001 administered by subcutaneous (SC) injection
Experimental (Induction Period - Arm 2) ORKA-001	Participants will receive 300 mg ORKA-001 per protocol Induction regimen.	Drug: ORKA-001 ORKA-001 administered by subcutaneous (SC) injection
Experimental (Induction Period - Arm 3) ORKA-001	Participants will receive 600 mg ORKA-001 per protocol Induction regimen.	Drug: ORKA-001 ORKA-001 administered by subcutaneous (SC) injection
Placebo Comparator (Induction Period - Arm 4) Placebo	Participants will receive Placebo per protocol Induction regimen.	Other: Placebo Placebo administered by subcutaneous (SC) injection
Experimental (Maintenance Period - Arm 1) ORKA-001	Participants will receive 300 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.	Drug: ORKA-001 ORKA-001 administered by subcutaneous (SC) injection
Experimental (Maintenance Period - Arm 2) ORKA-001	Participants will receive 600 mg ORKA-001 per protocol Maintenance regimen, based on protocol defined response.	Drug: ORKA-001 ORKA-001 administered by subcutaneous (SC) injection
Placebo Comparator (Maintenance Period - Arm 3) Placebo	Participants will receive Placebo per protocol Maintenance regimen, based on protocol defined response.	Other: Placebo Placebo administered by subcutaneous (SC) injection