Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Lebrikizumab Pen

Registration Number: NCT06444165

Lead Sponsor: Eli Lilly and Company

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 55

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lebrikizumab Pen	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Responded Agree or Strongly Agree to the 'Overall Ease of Use' Question Using the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)	Day 1	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.
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	Day 1	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.