A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Purpose
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.
Condition
- Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 125 Milligram (mg) Mirikizumab Q8W |
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W). |
|
Experimental 250 mg Mirikizumab Q8W Excluding Secukinumab |
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ) |
|
Experimental Secukinumab/250 mg Mirikizumab Q8W |
Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W. |
|
More Details
- Status
- Terminated
- Sponsor
- Eli Lilly and Company