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Monoclonal Antibodies
LY3454738 for Atopic Dermatitis
Phase 2
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit: EASI score ≥16, vIGA-AD score ≥3, and ≥10% of BSA involvement (per EASI BSA)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights
Study Summary
This trial studied the effectiveness and safety of a new drug for treating moderate-to-severe atopic dermatitis.
Who is the study for?
This trial is for adults with moderate-to-severe atopic dermatitis (AD), who need systemic therapy. Participants should have an EASI score of 16 or more, a vIGA-AD score of at least 3, and AD affecting 10% or more of their body. They must use emollients daily for two weeks before and throughout the study. Those with certain skin conditions, infections, medical issues, or recent treatments are excluded.Check my eligibility
What is being tested?
The trial is testing LY3454738's effectiveness and safety in treating AD compared to a placebo. Participants will be randomly assigned to receive either the investigational drug LY3454738 or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, common side effects from drugs like LY3454738 may include irritation at the injection site, headache, fatigue, nausea and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe eczema with a high EASI score, vIGA-AD score, and it covers more than 10% of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Secondary outcome measures
Mean Percent Change from Baseline in EASI
Mean Percent Change from Baseline in SCORAD
Percentage of Participants Achieving EASI-50
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3454738 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3454738 SC.
Group II: LY3454738 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3454738 SC.
Group III: LY3454738 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3454738 subcutaneously (SC).
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3454738
2018
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,339 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,485 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a candidate for treatment that affects my whole body.I am currently on medication applied to my skin or taken by mouth/injection.I do not have any listed skin conditions, infections, or serious health issues.I have recently been treated with experimental drugs, but it's required for some participants.I have severe eczema with a high EASI score, vIGA-AD score, and it covers more than 10% of my body.I have used a moisturizer daily for at least 2 weeks and will continue to do so during the study.
Research Study Groups:
This trial has the following groups:- Group 1: LY3454738 Dose 1
- Group 2: LY3454738 Dose 2
- Group 3: LY3454738 Dose 3
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How numerous are the medical facilities that have started this trial in North America?
"Fifty-six recruitment centres, such as Arkansas Research Trials in North Little Rock, Dermatology Research Associates in Los Angeles and Conquest Research in Winter Park are accepting enrolment into this clinical trial. Additional locations are also available to join the study."
Answered by AI
Are individuals aged sixty or more qualified for this research?
"This medical study is open to individuals that are 18 years or older, but have yet to reach the age of 70."
Answered by AI
May I join the research team for this clinical trial?
"Those chosen to participate in this trial must have atopic dermatitis and fall between the ages of 18-70. There is space for approximately 260 patients total."
Answered by AI
How has the safety of LY3454738 Dose 1 been assessed for human consumption?
"LY3454738 Dose 1 has been assessed with a score of 2 on the safety scale, as it is in its Phase 2 trial and only preliminary reports exist regarding its efficacy."
Answered by AI
Are there opportunities for participants to join this investigation?
"According to clinicaltrials.gov, this trial is not currently enrolling participants. The medical study was originally posted on the 15th of June 2023 and last updated a few days later - however, there are an array of other studies that require patients right now."
Answered by AI
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