Back to resultsA Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ixekizumab
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Xiangya Hospital, Central South University
- Second Affiliate Hospital of Zhejiang Medical University
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ixekizumab single dose
Ixekizumab Multiple Regimen 1 (80mg Q2W)
Ixekizumab Multiple Regimen 2 (80mg Q4W)
Arm Description
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Outcomes
Primary Outcome Measures
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
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.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Pharmacokinetics: 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)
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)
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03073213
Brief Title
A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 1, 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ixekizumab single dose
Arm Type
Experimental
Arm Description
Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
Arm Title
Ixekizumab Multiple Regimen 1 (80mg Q2W)
Arm Type
Experimental
Arm Description
Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
Arm Title
Ixekizumab Multiple Regimen 2 (80mg Q4W)
Arm Type
Experimental
Arm Description
Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab
Other Intervention Name(s)
LY2439821
Intervention Description
Administered as subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Description
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
Title
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
Description
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
Title
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Description
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
Title
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
Description
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
Title
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Second Affiliate Hospital of Zhejiang Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
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A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris
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