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Study of Ixekizumab in Healthy Participants

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: NCT03848403
Recruitment Status : Terminated (At the protocol-specified interim analysis, the sponsor decided to stop the trial.)
First Posted : February 20, 2019
Results First Posted : July 30, 2020
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions [ISRs]) will be collected.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ixekizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe in Healthy Subjects
Actual Study Start Date : January 29, 2019
Actual Primary Completion Date : July 18, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ixekizumab (Reference)
Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
 Biological: Ixekizumab
Administered SC
Other Name: LY2439821
Experimental: Ixekizumab (Test 1)
Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
 Biological: Ixekizumab
Administered SC
Other Name: LY2439821
Experimental: Ixekizumab (Test 2)
Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
 Biological: Ixekizumab
Administered SC
Other Name: LY2439821


Outcome Measures
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Primary Outcome Measures :
  1. Injection Pain Visual Analog Scale (VAS) Score [ Time Frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection ]
    The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male participants or female participants who agree not to get pregnant
  • Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant at increased risk by participating in the study

Exclusion Criteria:

  • Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
  • Are allergic or hypersensitive to the study medicine
  • Have dullness or loss of sensitivity on either side of your abdomen
  • Have any condition that could affect pain perception from an injection
  • Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
  • Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
  • Show evidence of active or latent tuberculosis (TB)
  • Presence of significant neuropsychiatric disorder or a recent history of depression
  • Have excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
  • Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator would pose an unacceptable risk to the participant if participating in the study
Contacts and Locations
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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): NCT03848403


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247-4989
United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] May 30, 2019
Statistical Analysis Plan  [PDF] January 8, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03848403    
Other Study ID Numbers: 17139
I1F-MC-RHCS ( Other Identifier: Eli Lilly and Company )
First Posted: February 20, 2019    Key Record Dates
Results First Posted: July 30, 2020
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ixekizumab
Dermatologic Agents