Phase 3
Completed N=55
Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis
Source: ClinicalTrials.gov NCT06444165 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
96.4 | — |
| 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 |
96.4 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06444165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.