Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis

The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.

This study involves one study visit.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Lebrikizumab Pen

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Concentrics Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-report being diagnosed with atopic dermatitis (AD) by a physician and able to provide approximate diagnosis date.
• Autoinjector or Pen naïve [have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (PFS) or vial and syringe].
• Willing and able to attend an in-person interview session.
• Able to complete the protocol requirements.

Exclusion Criteria:

• Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator.
• Are currently enrolled or have participated in the last 3 months, in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Is a health care practitioner who is trained in giving injections.
• Currently pregnant.
• Known hypersensitivity to any component of lebrikizumab or its excipients.
• Treatment with a live (or live attenuated) vaccine within the past 12 weeks.
• Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) per participant self-report.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab Pen; Participants were instructed (following training by the study team via a training video) to simulate a single-dose subcutaneous (SC) injection using a pen by directly injecting into an injection pad. The prefilled pen contained active drug (250 milligrams (mg)/2 milliliters (mL) lebrikizumab). No drug was administered to the participants during this study	Drug: Lebrikizumab Pen; Injected into a practice pad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Responded Agree or Strongly Agree to the 'Overall Ease of Use' Question Using the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)	mSQAAQ: This modified, short questionnaire is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Questions: 1) Easy for me to learn how to use, 2) Easy for me to unlock, 3) Easy to hold in my hand when I inject my dose, 4) Easy to inject my dose, 5) Easy to know that my dose is complete, 7) Easy to remove needle shield/cover, 8) Easy to pick up, 9) Overall, easy to use, 11) I am confident in my ability to use the device, and 12) I am confident my dose is complete. Responses were scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree' for each question. (1) Strongly disagree; (2) Disagree; (3) Slightly disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. A higher score indicates greater ease and confidence in using the lebrikizumab pen. This endpoint reports results for Question 9: Overall, easy to use.	Day 1
Percentage of Participants Who Responded Agree or Strongly Agree to the ' I am Confident in my Ability to Use the Device' Question Using the mSQAAQ	mSQAAQ: This modified, short questionnaire is an instrument that includes 10 questions about the ease of use and confidence in using the lebrikizumab pen. Questions 1) Easy for me to learn how to use, 2) Easy for me to unlock, 3) Easy to hold in my hand when I inject my dose, 4) Easy to inject my dose, 5) Easy to know that my dose is complete, 7) Easy to remove needle shield/cover, 8) Easy to pick up, 9) Overall easy to use, 11) I am confident in my ability to use the device, and 12) I am confident my dose is complete. Responses were scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree' for each question. (1) Strongly disagree; (2) Disagree; (3) Slightly disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. A higher score indicates greater ease and confidence in using the lebrikizumab pen. This endpoint reports results for Question 11: I am confident in my ability to use the device.	Day 1

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: 18826 (REB); J2T-MC-KGBY (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No