A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05735483
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Lebrikizumab — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Key Dates

Start date
Mar 9, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
310 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lebrikizumab
    Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
  • Experimental: Lebrikizumab - Optional Extension Period (OEP)
    During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.

Primary Outcome Measure

Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) [ Time Frame: Baseline through Week 52 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Clinical Research Center of AlabamaBirminghamAlabama35209-
Phoenix Children's HospitalPhoenixArizona85016-
Arkansas Research TrialsNorth Little RockArkansas72217-
First OC DermatologyFountain ValleyCalifornia92708-
Dermatology Research AssociatesLos AngelesCalifornia90045-
Integrative Skin Science and Research - Location 2SacramentoCalifornia95815-
UConn HealthFarmingtonConnecticut06030-
Solutions Through Advanced ResearchJacksonvilleFlorida32256-
ForCare Clinical ResearchTampaFlorida33613-
Treasure Valley Medical ResearchBoiseIdaho83706-
Northwestern UniversityChicagoIllinois60611-
Allergy and Asthma SpecialistOwensboroKentucky42301-
Massachusetts General HospitalBostonMassachusetts02114-
Great Lakes Research Group, Inc.Bay CityMichigan48706-
Respiratory Medicine Research Institute of Michigan, PLCYpsilantiMichigan48197-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766-
Wright State PhysiciansFairbornOhio45324-
Medical University of South CarolinaCharlestonSouth Carolina29425-
The University of Texas Health Science Center at HoustonBellaireTexas77401-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Clinical Research Center of Alabama· Birmingham, ALPhoenix Children's Hospital· Phoenix, AZArkansas Research Trials· North Little Rock, ARFirst OC Dermatology· Fountain Valley, CADermatology Research Associates· Los Angeles, CAIntegrative Skin Science and Research - Location 2· Sacramento, CA

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