Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Study to Assess Lebrikizumab Pen Ease of Use in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444165
• Other study ID #: 18826
• Secondary ID: J2T-MC-KGBY
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: This is a single site clinical trial 1-877-CTLILLY (1-877-285-45
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

This study involves one study visit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lebrikizumab Pen
Injected into a practice pad.

Locations

Country	Name	City	State
United States	Concentrics Research	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Responded Agree or Strongly Agree to the 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. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.	Day 1
Primary	Number of Participants Who Responded Agree or Strongly Agree to the Confidence of Use 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. Responses are scored on a 7-point Likert scale ranging from 'strongly disagree' to 'strongly agree:' (1) Strongly disagree; (2) Disagree; (3) Slightly Disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree. Each question will be analyzed and presented individually.	Day 1