Dose Ranging Study of ORKA-002 in Patients With Moderate-to-Severe Plaque Psoriasis
Recruiting
Phase 2Interventional Study
Plaque Psoriasis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 79
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Oruka Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with moderate-to-severe plaque psoriasis. Participants will test a treatment called ORKA-002 to see how well it works and how safe it is.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with plaque psoriasis for more than 6 months.
I have moderate-to-severe chronic plaque psoriasis.
I am a candidate for systemic therapy or phototherapy.
I am a woman of childbearing potential and have a negative pregnancy test.
You may not be able to join if
I have a nonplaque form of psoriasis.
I have a significant history of serious medical conditions.
I have had cancer in the past 5 years, except for certain skin cancers.
I am allergic to any components of the ORKA-002 drug.
I am currently breastfeeding or plan to breastfeed during the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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. Cand…
Inclusion Criteria:
1. 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:
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-002 drug product
5. Women who are breastfeeding or plan to breastfeed during the study
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