RECRUITINGPhase 2INTERVENTIONAL
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. 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.
Who Should NOT Join This Trial:
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-001 drug product
5. Women who are breastfeeding or plan to breastfeed during the study
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. 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:
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-001 drug product
5. Women who are breastfeeding or plan to breastfeed during the study
Treatments Being Tested
DRUG
ORKA-001
ORKA-001 administered by subcutaneous (SC) injection
OTHER
Placebo
Placebo administered by subcutaneous (SC) injection
Locations (20)
Oruka Therapeutics Investigative Site
Phoenix, Arizona, United States
Oruka Therapeutics Investigative Site
North Little Rock, Arkansas, United States
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
Los Angeles, California, United States
Oruka Therapeutics Investigative Site
San Diego, California, United States
Oruka Therapeutics Investigative Site
Coral Gables, Florida, United States
Oruka Therapeutics Investigative Site
Rolling Meadows, Illinois, United States
Oruka Therapeutics Investigative Site
Plainfield, Indiana, United States
Oruka Therapeutics Investigative Site
Rockville, Maryland, United States
Oruka Therapeutics Investigative Site
Kew Gardens, New York, United States
Oruka Therapeutics Investigative Site
Chapel Hill, North Carolina, United States
Oruka Therapeutics Investigative Site
Cleveland, Ohio, United States
Oruka Therapeutics Investigative Site
Mason, Ohio, United States
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Oruka Therapeutics Investigative Site
Portland, Oregon, United States
Oruka Therapeutics Investigative Site
Philadelphia, Pennsylvania, United States
Oruka Therapeutics Investigative Site
Frisco, Texas, United States
Oruka Therapeutics Investigative Site
Houston, Texas, United States
Oruka Therapeutics Investigative Site
Webster, Texas, United States
Oruka Therapeutics Investigative Site
Norfolk, Virginia, United States