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

ArmDescriptionAssigned Intervention
Experimental
125 Milligram (mg) Mirikizumab Q8W 		Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
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)
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828
Experimental
Secukinumab/250 mg Mirikizumab Q8W 		Participants from previous originating study [who received secukinumab (AMAJ)] received 250 mg mirikizumab administered SC Q8W.
  • Drug: Mirikizumab
    Administered SC
    Other names:
    • LY3074828

More Details

Status
Terminated
Sponsor
Eli Lilly and Company

Study Contact