A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Ixekizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ixekizumab single dose<br>Participants received single dose of 80mg Ixekizumab by subcutaneous injection. | Drug: Ixekizumab<br>* Administered as subcutaneous (SC) injection<br>* Other names: LY2439821;|
| Experimental: Ixekizumab Multiple Regimen 1 (80mg Q2W)<br>Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. | Drug: Ixekizumab<br>* Administered as subcutaneous (SC) injection<br>* Other names: LY2439821;|
| Experimental: Ixekizumab Multiple Regimen 2 (80mg Q4W)<br>Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. | Drug: Ixekizumab<br>* Administered as subcutaneous (SC) injection<br>* Other names: LY2439821;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) | Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum. | 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. | 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. | 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). | 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). | day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85 |