Tests ORKA-001 long term in people with plaque psoriasis
Checks long-term safety of ORKA-001 in adults with moderate-to-severe plaque psoriasis.
Plain-language title generated from the registry record
Registry title: An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
Key facts
- Where
- Badalona, Barcelona, and Madrid, SpainSee the 4 sites
- Phase
- Phase 2
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainNot yet recruiting
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNot yet recruiting
- Hospital Universitario La PazMadrid, SpainNot yet recruiting
- Icr Medical S.L.Madrid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oruka Therapeutics, Inc.
- Trial code
- NCT07449702EU 2026-526898-42-00
- Record updated
- 23 October 2026
- Original description
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.Read full original descriptionShow less
An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.
Inclusion: Signed informed consent by participants from previous trial choosing to transition into the OLE; Participants who have successfully completed the preceding trial; For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit; For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception.
Exclusion: Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001; Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial; Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data; Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001; Participant is pregnant or breastfeeding.