NCT03364309

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Ixekizumab	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2018-04-26
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2017-12-06
• Last updated: 2021-06-25
• Results posted: 2021-06-25

Locations

17 sites across 1 country: China

Regulatory

• FDA-regulated drug study