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

Lilly

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Ixekizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364309

14438

I1F-MC-RHBH (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.
• Have ≥10% BSA involvement at screening and baseline.
• Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.
• Are candidates for phototherapy and/or systemic therapy.

Exclusion criteria

• Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
• Drug-induced psoriasis.
• Ongoing use of prohibited treatments.
• Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.
• Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to baseline, whichever is longer.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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438 participants in 3 patient groups, including a placebo group

Ixekizumab 80mg Q4W

Experimental group

Description:

Participants 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.

Treatment:

Drug: Ixekizumab

Ixekizumab 80mg Q2W

Experimental group

Description:

Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.

Treatment:

Drug: Ixekizumab

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.

Treatment:

Drug: Placebo