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
Oruka Therapeutics Investigative Site
Birmingham, Alabama 35203
Birmingham, Alabama 35203
Oruka Therapeutics Investigative Site
Phoenix, Arizona 85032
Phoenix, Arizona 85032
Oruka Therapeutics Investigative Site
Fountain Valley, California 92708
Fountain Valley, California 92708
Oruka Therapeutics Investigative Site
Los Angeles, California 90045
Los Angeles, California 90045
Oruka Therapeutics Investigative Site
San Diego, California 92123
San Diego, California 92123
Oruka Therapeutics Investigative Site
Santa Ana, California 92701
Santa Ana, California 92701
Oruka Therapeutics Investigative Site
Santa Monica, California 90403
Santa Monica, California 90403
Oruka Therapeutics Investigative Site
Cromwell, Connecticut 06416
Cromwell, Connecticut 06416
Oruka Therapeutics Investigative Site
Miami, Florida 33124
Miami, Florida 33124
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois 60008
Rolling Meadows, Illinois 60008
Oruka Therapeutics Investigative Site
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Oruka Therapeutics Investigative Site
Milford, Massachusetts 01757
Milford, Massachusetts 01757
Oruka Therapeutics Investigative Site
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Oruka Therapeutics Investigative Site
Detroit, Michigan 48202
Detroit, Michigan 48202
Oruka Therapeutics Investigative Site
Warren, Michigan 48088
Warren, Michigan 48088
Oruka Therapeutics Investigative Site
New Brighton, Minnesota 55112
New Brighton, Minnesota 55112
Oruka Therapeutics Investigative Site
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Oruka Therapeutics Investigative Site
Elmhurst, New York 11373
Elmhurst, New York 11373
Oruka Therapeutics Investigative Site
New York, New York 10029
New York, New York 10029
Oruka Therapeutics Investigative Site
Wilmington, North Carolina 28405
Wilmington, North Carolina 28405
Oruka Therapeutics Investigative Site
Bexley, Ohio 43209
Bexley, Ohio 43209
Oruka Therapeutics Investigative Site
Portland, Oregon 97201
Portland, Oregon 97201
Oruka Therapeutics Investigative Site
Warrenton, Oregon 97146
Warrenton, Oregon 97146
Oruka Therapeutics Investigative Site
Charleston, South Carolina 29407
Charleston, South Carolina 29407
Oruka Therapeutics Investigative Site
Dallas, Texas 75231
Dallas, Texas 75231
Oruka Therapeutics Investigative Site
Dallas, Texas 75390
Dallas, Texas 75390
Oruka Therapeutics Investigative Site
Houston, Texas 77004
Houston, Texas 77004
Oruka Therapeutics Investigative Site
Webster, Texas 77598
Webster, Texas 77598
Oruka Therapeutics Investigative Site
Mill Creek, Washington 98012
Mill Creek, Washington 98012
More Details
- 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