臨床研究等提出・公開システム

A Multicenter, Long-Term Extension to Evaluate the Long-Term Safety and Maintenance of Treatment Effect of Mirikizumab in Patients with Moderate-to-Severe Plaque Psoriasis(OASIS-3)

I6T-MC-AMAH

Eli Lilly Japan K.K.

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Eli Lilly Japan K.K.

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+81-120-023-812

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completed

Dec. 21, 2018

Interventional

Long-term study in which patients completing 1 of the 4 originator studies will receive 250 mg or 125 mg mirikizumab Q8W, administered SC, for an extended period of time (approximately 4 years or until commercial availability of mirikizumab) and then enter a 12-week Post-Treatment Follow-Up period.

treatment purpose

3

- 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.

- 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 if the study investigator does not think the participant should resume taking mirikizumab.

Both

Psoriasis

investigational material(s)
Generic name etc : LY3074828
INN of investigational material : Mirikizumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Mirikizumab administered subcutaneously (SC)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
-Percentage of participants with an sPGA of (0,1) among those who entered the study with a sPGA of 0,1
-Percentage of participants who maintained a greater than or equal to 90% improvement in PASI 90 among those who entered the study with a PASI 90.

efficacy
other
-Percentage of patients achieving a 100% improvement in PASI 100.
-Percentage of participants with a PSS symptom score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score greater than or equal to 1 at baseline.
-Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0,1 with baseline score greater than 1.
-Percent change from baseline in PPASI total score in participants with palmoplantar involvement at baseline.
-Percent change from baseline in PSSI total score in participants with scalp involvement at baseline.
-Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.

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Oct. 04, 2018