Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis
- 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
- 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.
- 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 Injection of lebrikizumab pen into a practice pad.
- Primary Outcome Measures
Name Time Method Number of Participants Who Responded Agree or Strongly Agree to the 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. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.
Number of Participants Who Responded Agree or Strongly Agree to the Confidence of Use 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. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Concentrics Research
🇺🇸Indianapolis, Indiana, United States