Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2024-06-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Lebrikizumab Pen

Intervention Type DRUG

Injected into a practice pad.

Interventions

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Lebrikizumab Pen

Injected into a practice pad.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No