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I6T-MC-AMAH

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)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224141
Enrollment
150
Registered
2018-11-13
Start date
2018-12-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026