ACTIVE_NOT_RECRUITING

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

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Conditions

Atopic DermatitisEczema

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Quick Facts

Study Start:2022-10-18
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05559359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
  2. * 12 months if participants are ≥6 years of age
  3. * 6 months if participants are 2 to \<6 years of age
  4. * 3 months if participants are 6 months to \<2 years of age.
  5. * Have an EASI score ≥16 at the screening and baseline
  6. * Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
  7. * Have ≥10% BSA of AD involvement at the screening and baseline.
  1. * Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
  2. * Treatment with the following prior to the baseline:
  3. * An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
  4. * Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
  5. * Treatment with a topical investigational drug within 2 weeks prior to the baseline.
  6. * Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Clinical Research Center of Alabama
Birmingham, Alabama, 35209
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Research Trials
North Little Rock, Arkansas, 72217
United States
First OC Dermatology
Fountain Valley, California, 92708
United States
Antelope Valley Clinical Trials
Lancaster, California, 93534
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
Rady's Children Hospital San Diego - Dermatology
San Diego, California, 92123
United States
UConn Health
Farmington, Connecticut, 06030-2840
United States
Solutions Through Advanced Research
Jacksonville, Florida, 32256
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
Northwestern University
Chicago, Illinois, 60611
United States
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, 42301
United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
United States
Dermatologists of Central States, LLC
Fairborn, Ohio, 45324
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-18
Study Completion Date2026-12

Study Record Updates

Study Start Date2022-10-18
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Atopic Dermatitis
  • Eczema