Atopic DermatitisPhase 3NCT06444165
Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis
A Phase 3 study testing Lebrikizumab Pen in people with Atopic Dermatitis, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lebrikizumab Pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 10 Jun 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Assess Lebrikizumab Pen Ease of Use in Patients 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Lebrikizumab Pen
- Keywords
- Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lebrikizumab PenDrug
Injected into a practice pad.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab Pen | Experimental | 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 Receives: Drug: Lebrikizumab Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Jun 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444165
- Sponsor's protocol ID
- 18826
- Other IDs
- J2T-MC-KGBY
- Status last verified
- Jul 2025
- First submitted
- 31 May 2024
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.