An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis
ConditionPlaque Psoriasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOruka Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ORKA-001
Treatment groups
240 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov