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

Active Not RecruitingPhase 2

Sponsor: Oruka Therapeutics, Inc.

Conditions: Plaque Psoriasis

Interventions: ORKA-001, Placebo

Countries: United States, Canada, Germany, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (36)

Phoenix, Arizona, United States
North Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
Miami, Florida, United States
Rolling Meadows, Illinois, United States
Plainfield, Indiana, United States
Rockville, Maryland, United States
Kew Gardens, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Mason, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Frisco, Texas, United States
Houston, Texas, United States
Webster, Texas, United States
Norfolk, Virginia, United States
Surrey, British Columbia, Canada
Surrey, British Columbia, Canada
Fredericton, New Brunswick, Canada
Ajax, Ontario, Canada
Markham, Ontario, Canada
Peterborough, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Heidelberg, Baden-Wuerrtemberg, Germany
Frankfurt am Main, Hesse, Germany
+ 6 more on CT.gov