A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT03364309
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ixekizumab — DRUGAdministered SC
- Placebo — DRUGAdministered SC
Study Details
The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
Key Dates
- Start date
- Apr 26, 2018
- Status verified
- Jun 2021
- Primary completion
- Jun 4, 2020
- Completion
- Jun 4, 2020
Study Design
- Enrollment
- 438 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ixekizumab 80mg Q4WParticipants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.
- Experimental: Ixekizumab 80mg Q2WParticipants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.
- Placebo Comparator: PlaceboParticipants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
Primary Outcome Measure
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement [ Time Frame: Week 12 ]
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