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New treatment option for Plaque Psoriasis
Official title Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT07290569
What this study is testing
What is ORKA-001?
ORKA-001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for plaque psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for \> 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- BSA ≥ 10%, and
- PASI ≥ 12, and
You likely can't join if
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular...
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- A known hypersensitivity to any components of the ORKA-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
See the full eligibility criteria
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for \> 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- BSA ≥ 10%, and
- PASI ≥ 12, and
- IGA score of ≥ 3 on a 5-point scale
- Candidate for systemic therapy or phototherapy
- Women of childbearing potential must have a negative pregnancy test.
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric...
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- A known hypersensitivity to any components of the ORKA-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- North Little Rock, Arkansas, 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
- Philadelphia, Pennsylvania, United States
- Frisco, Texas, United States
- Houston, Texas, United States
- Webster, Texas, United States
- Norfolk, Virginia, United States
- Surrey, British Columbia, Canada
- Fredericton, New Brunswick, Canada
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; North Little Rock, Arkansas, United States; Los Angeles, California, United States; San Diego, California, United States; Miami, Florida, United States; Rolling Meadows, Illinois, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.