Lebrikizumab (Cohort 1) for Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dermatitis+3 More
Lebrikizumab - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test lebrikizumab, a potential new treatment for atopic dermatitis, in children aged 6 months to 18 years. The trial will measure the effect, safety and how well the body absorbs lebrikizumab.

Eligible Conditions
  • Dermatitis
  • Eczema

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: Baseline, Week 16

Baseline to Week 1
Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline
Baseline to Week 16
Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score
Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
Baseline, Week 16
Change from Baseline in Body Surface Area (BSA)
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM)
Percentage Change from Baseline in EASI Score
Percentage Change from Baseline in Pruritus NRS Score
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
Week 14
Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Lebrikizumab (Cohort 1)
1 of 3
Lebrikizumab (Cohort 2)
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

300 Total Participants · 3 Treatment Groups

Primary Treatment: Lebrikizumab (Cohort 1) · Has Placebo Group · Phase 3

Lebrikizumab (Cohort 1)Experimental Group · 2 Interventions: Lebrikizumab, Topical corticosteroid · Intervention Types: Drug, Drug
Lebrikizumab (Cohort 2)Experimental Group · 2 Interventions: Lebrikizumab, Topical corticosteroid · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Topical corticosteroid, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
2014
Completed Phase 3
~5890
Topical corticosteroid
2018
Completed Phase 4
~830

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 16

Who is running the clinical trial?

Dermira, Inc.Industry Sponsor
16 Previous Clinical Trials
5,583 Total Patients Enrolled
7 Trials studying Dermatitis
2,604 Patients Enrolled for Dermatitis
Eli Lilly and CompanyLead Sponsor
2,455 Previous Clinical Trials
3,120,543 Total Patients Enrolled
24 Trials studying Dermatitis
10,022 Patients Enrolled for Dermatitis
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,252 Previous Clinical Trials
367,371 Total Patients Enrolled
22 Trials studying Dermatitis
8,448 Patients Enrolled for Dermatitis

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have ≥10% BSA of AD involvement at the screening and baseline.
Have a diagnosis of Alzheimer's disease prior to screening as stated in the criteria by the American Academy of Neurology.
You have 6 months if participants are 6 months to <6 years of age.
You have an EASI score ≥16 at the screening and baseline.
You have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.