A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

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

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 Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Ixekizumab

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200025
    • Ruijin Hospital Affiliated to Shanghai Jiao Tong University
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital, Central South University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliate Hospital of Zhejiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2017
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ixekizumab
• Other Study ID Numbers: 15371; I1F-MC-RHBN (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes