Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Lilly

Status and phase

Completed

Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Lebrikizumab Pen

Study type

Interventional

Funder types

Industry

Identifiers

NCT06444165

J2T-MC-KGBY (Other Identifier)

18826 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.