A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3

16491

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

2018-09-03

2022-02-07

2022-02-07

Terminated

Early phase I

1936

Inclusion Criteria: * Participant must have completed the last visit of an eligible study period of originating study. * Participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential. Exclusion Criteria: * Participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study. * Participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Initially double-blind (until original, pivotal studies AMAK \\[NCT03482011\\] and AMAJ \\[NCT03535194\\] are locked and unblinded), then open-label.'}}, 'enrollmentInfo': {'count': 1936, 'type': 'ACTUAL'}}

2023-03-21