Trial Outcomes & Findings for Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis (NCT NCT06444165)

Last Updated: 2025-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

55 participants

Primary outcome timeframe

Day 1

Results posted on

2025-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lebrikizumab Pen n=55 Participants 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.
Age, Continuous	50.1 Years STANDARD_DEVIATION 16.37 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled patients

Outcome measures

Outcome measures
Measure	Lebrikizumab Pen n=55 Participants 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.
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

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Lebrikizumab Pen n=55 Participants 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.
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

Adverse Events

Lebrikuzimab Pen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08004595979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60