A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Eli Lilly and Company32 enrolled

Overview

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

IxekizumabDRUG

Administered as subcutaneous (SC) injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females aged ≥18 years. * Diagnosis of chronic plaque psoriasis for ≥6 months before baseline. * Candidates for phototherapy and/or systemic therapy. * ≥10% body surface area (BSA) involvement at screening and baseline. * static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline. Exclusion Criteria: * Clinically significant flare of psoriasis during the 12 weeks before baseline. * Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline . * Current or recent use of any biologic agent within the required washout periods. * Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Locations (3)

Xiangya Hospital, Central South University

Changsha, Hunan, China

Second Affiliate Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, China

Outcomes

Primary Outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)

Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.

Time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.

Time frame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)

Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.

Time frame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197

Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)

Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).

Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71

Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)

Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85

Data from ClinicalTrials.gov

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