Dose Ranging Study of ORKA-002 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-002 in adult participants with moderate-to-severe plaque psoriasis.
Condition
- Plaque Psoriasis
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
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-002 |
Participants will receive ORKA-002 per protocol Induction regimen. |
|
|
Experimental (Induction Period - Arm 2) ORKA-002 |
Participants will receive ORKA-002 per protocol Induction regimen. |
|
|
Experimental (Induction Period - Arm 3) ORKA-002 |
Participants will receive ORKA-002 per protocol Induction regimen. |
|
|
Placebo Comparator (Induction Period - Arm 4) Placebo |
Participants will receive Placebo per protocol Induction regimen. |
|
Recruiting Locations
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama 35203
Birmingham, Alabama 35203
First OC Dermatology Research, Inc.
Fountain Valley, California 92708
Fountain Valley, California 92708
TCR Medical Corporation
San Diego, California 92123
San Diego, California 92123
Southern California Clinical Research
Santa Ana, California 92701
Santa Ana, California 92701
Institute of Clinical Research and Consulting, Inc., d/b/a Clinical Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
Central Connecticut Dermatology Research, PLLC
Cromwell, Connecticut 06416
Cromwell, Connecticut 06416
Driven Research LLC
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts 01757
Milford, Massachusetts 01757
Henry Ford Medical Center
Detroit, Michigan 48202
Detroit, Michigan 48202
Grekin Skin Institute
Warren, Michigan 48088
Warren, Michigan 48088
Associated Skin Care Specialists, PA d/b/a Minnesota Clinical Study Center
New Brighton, Minnesota 55112
New Brighton, Minnesota 55112
Skin Specialists, PC dba Schlessinger MD
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Icahn School of Medicine at Mount Sinai, Department of Dermatology
New York, New York 10029
New York, New York 10029
WDC Cosmetic and Research, PLLC
Wilmington, North Carolina 28405
Wilmington, North Carolina 28405
Bexley Dermatology Research
Bexley, Ohio 43209
Bexley, Ohio 43209
Clear Choice Dermatology LLC
Warrenton, Oregon 97146
Warrenton, Oregon 97146
Modern Research Associates, PLLC
Dallas, Texas 75231
Dallas, Texas 75231
Frontier Derm Partners CRO LLC
Mill Creek, Washington 98012
Mill Creek, Washington 98012
More Details
- NCT ID
- NCT07474792
- Status
- Recruiting
- Sponsor
- Oruka Therapeutics, Inc.
Detailed Description
This is a multicenter, randomized, double-blinded, placebo-controlled, dose range finding study designed to identify the optimal induction dosing regimen of ORKA-002 in approximately 160 adult participants with moderate-to-severe plaque psoriasis. The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-002 compared to placebo. The study will consist of 3 periods: - Screening Period - Induction Period - Post-treatment Follow-up Period