A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ixekizumab single dose	Ixekizumab	Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
Ixekizumab Multiple Regimen 1 (80mg Q2W)	Ixekizumab	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
Ixekizumab Multiple Regimen 2 (80mg Q4W)	Ixekizumab	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)	Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141	Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)	day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197	Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)	Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141	Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)	day 57 (Pre-dose), 59, 61, 64, 67, 71	Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)	day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85	Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Secondary Outcome Measures

Name	Time	Method

Locations (3): Xiangya Hospital, Central South University
🇨🇳
Changsha, Hunan, China
Second Affiliate Hospital of Zhejiang Medical University
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Hangzhou, Zhejiang, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
🇨🇳
Shanghai, China