Atopic Dermatitis
Conditions
Keywords
Eczema
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.
Interventions
DRUGLebrikizumab Pen
Injected into a practice pad.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lebrikizumab Pen Participants were instructed (following training by the study team via a training video) to simulate a single-dose SC injection using a pen by directly injecting into the injection pad. The prefilled pen contained the active drug (250 mg/2 mL lebrikizumab).
No drug was administered to the participants during this study. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Lebrikizumab Pen |
|---|---|
| Age, Continuous | 50.1 Years STANDARD_DEVIATION 16.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 55 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
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.
Time frame: Day 1
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab Pen | 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 | 96.4 percentage of participants |
Primary
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.
Time frame: Day 1
Population: All enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lebrikizumab Pen | Percentage of Participants Who Responded Agree or Strongly Agree to the 'Overall Ease of Use' Question Using the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) | 96.4 percentage of participants |