NCT07090330Active, not recruitingPhase 2
ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis
A Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
This is a multicenter, randomized, double-blinded, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 18 Jul 2025
- Primary completion date
- 25 Mar 2026
- Lead sponsor
- Oruka Therapeutics, Inc.
- Diseases
- Psoriasis
- NCT number
- NCT07090330
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 18 Jul 2025 to the primary completion date, 25 Mar 2026
- 24 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
Other illness
- 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
- A known hypersensitivity to any components of the ORKA-001 drug product
Age
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
Other
- Women who are breastfeeding or plan to breastfeed during the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.