ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 29 for:    LY2439821

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03073213
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Ixekizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : June 17, 2019
Estimated Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab single dose
Ixekizumab administered subcutaneously (SC) once
Drug: Ixekizumab
Administered as SC injection
Other Name: LY2439821

Experimental: Ixekizumab Multiple Regimen 1
Ixekizumab administered SC on multiple occasions
Drug: Ixekizumab
Administered as SC injection
Other Name: LY2439821

Experimental: Ixekizumab Multiple Regimen 2
Ixekizumab administered SC on multiple occasions
Drug: Ixekizumab
Administered as SC injection
Other Name: LY2439821




Primary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab [ Time Frame: Baseline through 20 weeks for single dose phase and through 28 weeks for multiple dose phase, after administration of study drug ]
    Pharmacokinetics: Cmax of Ixekizumab

  2. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Ixekizumab [ Time Frame: Baseline through 20 weeks for single dose phase and through 28 weeks for multiple dose phase, after administration of study drug ]
    Pharmacokinetics: AUC of Ixekizumab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants with chronic plaque psoriasis (greater than or equal to 10 percent (%) body surface area (BSA); static Physician's Global Assessment (sPGA) score of greater than or equal to 3 and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12) at least 6 months before baseline
  • Have a body mass index between 18 and 35 kilogram per meter square (kg/m²)

Exclusion Criteria:

  • Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists
  • Have an active or recent infection or a compromised immune system
  • Have active or dormant tuberculosis
  • Have a serious or unstable/uncontrolled illness, including heart disease, abnormal blood pressure, mental disorder, malignancy or other disease
  • Be pregnant or breastfeeding
  • Had any major surgery within 8 weeks prior to baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073213


Locations
China, Hunan
Xiangya Hospital, Central South University
Changsha, Hunan, China
China, Zhejiang
Second Affiliate Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, China, 310009
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China, 200025
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03073213     History of Changes
Other Study ID Numbers: 15371
I1F-MC-RHBN ( Other Identifier: Eli Lilly and Company )
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 11, 2019

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Dermatologic Agents