NCT07290569Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients with Moderate-to-Severe Plaque Psoriasis (EVERLAST-B)
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Dose-Range Finding Study of ORKA-001 in Participants with Moderate-to-Severe Plaque Psoriasis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Aug 2026
Brief summary (registry, in English)
To evaluate the efficacy of ORKA-001 compared to placebo and select the induction dose regimen of ORKA-001 with the optimal benefit-risk profile in participants with moderate-to-severe plaque psoriasis
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 13 Jan 2026
- Start date
- 8 May 2026
- Lead sponsor
- Oruka Therapeutics Inc.
- Diseases
- Psoriasis
- NCT number
- NCT07290569
- EU CT number
- 2025-523797-17-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) 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: a. BSA ≥ 10%, and b. PASI ≥ 12, and c. 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 (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Active, not recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Icr Medical S.L. Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.