A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT03535194
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Mirikizumab — DRUGAdministered SC
- Placebo — DRUGAdministered SC
- Secukinumab — DRUGAdministered SC
Study Details
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
Key Dates
- Start date
- Jun 26, 2018
- Status verified
- Aug 2020
- Primary completion
- Mar 5, 2020
- Completion
- Jun 3, 2020
Study Design
- Enrollment
- 1,484 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 250mg Q4W/250mg Q8W MirikizumabParticipants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
- Experimental: 250mg Q4W/125mg Q8W MirikizumabParticipants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
- Experimental: Placebo/250mg MirikizumabParticipants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
- Active Comparator: 300mg SecukinumabParticipants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period followed by 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
- Experimental: Japan GPP/EPParticipants received 250mg Mirikizumab Q4W in induction period followed by 250mg Q8W in maintenance period by subcutaneous injection.
Primary Outcome Measure
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline [ Time Frame: Week 16 ]
Locations (42)
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University of Alabama at Birmingham· Birmingham, ALBakersfield Dermatology and Skin Cancer Medical Group· Bakersfield, CADavid Stoll, M.D.· Beverly Hills, CACalifornia Dermatology and Clinical Research Institute· Encinitas, CATien Q. Nguyen, MD inc. DBA First OC Dermatology· Fountain Valley, CAKeck School of Medicine University of Southern California· Los Angeles, CA
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