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

Condition studied

Moderate-to-Severe Plaque Psoriasis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence of treatment adverse events, treatment-emergent serious adverse events, treatment adverse events of special interest, and potential clinically significant changes from baseline in vital signs, clinical laboratory parameters and electrocardiograms.

Endpoint detail

Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE, Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE, Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE, Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE, Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline, Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE, Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE, PASI Score Over Time, IGA Score Over Time