Clinical Trials in Spain / NCT07290569
Active, not recruiting
Phase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
NCT07290569 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Plaque Psoriasis
Investigational drug(s) / intervention(s)
ORKA-001 →Placebo
ORKA-001: ORKA-001 administered by subcutaneous (SC) injection
Placebo: Placebo administered by subcutaneous (SC) injection
Study summary
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
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
Primary outcome measure(s)
- Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 — Week 16
The Psoriasis Area and Severity Index Score (PASI) is an evaluation tool that combines the assessment of the severity and the area affected by psoriasis into a single score ranging from 0 (no disease) to 72 (maximum disease).
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Oruka Therapeutics Investigative Site | Phoenix | Arizona | |
| Oruka Therapeutics Investigative Site | North Little Rock | Arkansas | |
| Oruka Therapeutics Investigative Site | Los Angeles | California | |
| Oruka Therapeutics Investigative Site | Los Angeles | California | |
| Oruka Therapeutics Investigative Site | San Diego | California | |
| Oruka Therapeutics Investigative Site | Miami | Florida | |
| Oruka Therapeutics Investigative Site | Rolling Meadows | Illinois | |
| Oruka Therapeutics Investigative Site | Plainfield | Indiana | |
| Oruka Therapeutics Investigative Site | Rockville | Maryland | |
| Oruka Therapeutics Investigative Site | Kew Gardens | New York | |
| Oruka Therapeutics Investigative Site | Chapel Hill | North Carolina | |
| Oruka Therapeutics Investigative Site | Cleveland | Ohio | |
| Oruka Therapeutics Investigative Site | Mason | Ohio | |
| Oruka Therapeutics Investigative Site | Portland | Oregon | |
| Oruka Therapeutics Investigative Site | Portland | Oregon | |
| Oruka Therapeutics Investigative Site | Philadelphia | Pennsylvania | |
| Oruka Therapeutics Investigative Site | Frisco | Texas | |
| Oruka Therapeutics Investigative Site | Houston | Texas | |
| Oruka Therapeutics Investigative Site | Webster | Texas | |
| Oruka Therapeutics Investigative Site | Norfolk | Virginia | |
| Oruka Therapeutics Investigative Site | Surrey | British Columbia | |
| Oruka Therapeutics Investigative Site | Surrey | British Columbia | |
| Oruka Therapeutics Investigative Site | Fredericton | New Brunswick | |
| Oruka Therapeutics Investigative Site | Ajax | Ontario | |
| Oruka Therapeutics Investigative Site | Markham | Ontario | |
| Oruka Therapeutics Investigative Site | Peterborough | Ontario | |
| Oruka Therapeutics Investigative Site | Montreal | Quebec | |
| Oruka Therapeutics Investigative Site | Québec | Quebec | |
| Oruka Therapeutics Investigative Site | Heidelberg | Baden-Wuerrtemberg | |
| Oruka Therapeutics Investigative Site | Frankfurt am Main | Hesse | |
| Oruka Therapeutics Investigative Site | Bad Bentheim | Lower Saxony | |
| Oruka Therapeutics Investigative Site | Kiel | Schleswig-Holstein | |
| Oruka Therapeutics Investigative Site | Badalona | Barcelona | |
| Oruka Therapeutics Investigative Site | Barcelona | Barcelona | |
| Oruka Therapeutics Investigative Site | Madrid | Madrid | |
| Oruka Therapeutics Investigative Site | Madrid | Madrid |
Other trials for the same condition
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Active, not recruiting
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07290569 on ClinicalTrials.gov ↗ ← All trials in Spain