A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Psoriasis

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556202

I6T-MC-AMAH (Other Identifier)

2017-003299-30 (EudraCT Number)

16491

Details and patient eligibility

About

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.

Enrollment: 1,936 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,936 participants in 3 patient groups

125 Milligram (mg) Mirikizumab Q8W

Experimental group

Description:

Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).

Treatment:

Drug: Mirikizumab

250 mg Mirikizumab Q8W Excluding Secukinumab

Experimental group

Description:

Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)

Treatment:

Drug: Mirikizumab

Secukinumab/250 mg Mirikizumab Q8W

Experimental group

Description:

Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.

Treatment:

Drug: Mirikizumab