Skip to main content
OpenTrials
Completed

NCT Number: NCT06444165

Lebrikizumab Pen Ease of Use in Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Concentrics Research

Indianapolis, Indiana, 46240, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lebrikizumab Pen

Drug

Injected into a practice pad.

Primary outcomes

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

    Time frame: 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.

  2. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.