Atopic Dermatitis Clinical Trials

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A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden

Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy. Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.

• Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.

• Have pruritus numeric rating scale (NRS) ≥6 at baseline.

• Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.

• Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.

• Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.

• For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.

Locations
United States
Alabama
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
ACTIVE_NOT_RECRUITING
Birmingham
Arizona
Research Solutions of Arizona
RECRUITING
Litchfield Park
Alliance Dermatology and Mohs Center
ACTIVE_NOT_RECRUITING
Phoenix
California
California Dermatology & Clinical Research Institute
RECRUITING
Encinitas
First OC Dermatology Research Inc
RECRUITING
Fountain Valley
Dermatology Research Associates
ACTIVE_NOT_RECRUITING
Los Angeles
NorCal Clinical Research
ACTIVE_NOT_RECRUITING
Rocklin
Florida
Suncoast Research Associates
COMPLETED
Doral
Encore Medical Research
ACTIVE_NOT_RECRUITING
Hollywood
Solutions Through Advanced Research
ACTIVE_NOT_RECRUITING
Jacksonville
Health Clinical Research
ACTIVE_NOT_RECRUITING
Miami
Life Arc Research Centers - Miami
COMPLETED
Miami
MCR Research
ACTIVE_NOT_RECRUITING
Miami
Deluxe Health Center
ACTIVE_NOT_RECRUITING
Miami Lakes
Renstar Medical Research
COMPLETED
Ocala
Leading Edge Dermatology
ACTIVE_NOT_RECRUITING
Plantation
Research Institute of the Southeast
RECRUITING
West Palm Beach
Georgia
Dermatology Affiliates Research Institute
COMPLETED
Atlanta
Illinois
DeNova Research
ACTIVE_NOT_RECRUITING
Chicago
Indiana
Southern Indiana Clinical Research Center
COMPLETED
Columbus
Dawes Fretzin Clinical Research Group, LLC
ACTIVE_NOT_RECRUITING
Indianapolis
Southern Indiana Clinical Trials
ACTIVE_NOT_RECRUITING
New Albany
Kentucky
Equity Medical - Bowling Green
ACTIVE_NOT_RECRUITING
Bowling Green
Allergy & Asthma Specialists, P.S.C.
COMPLETED
Owensboro
Maryland
Foxhall Research Center
COMPLETED
Chevy Chase
Michigan
Great Lakes Research Group, Inc.
RECRUITING
Bay City
Revival Research Institute, LLC
ACTIVE_NOT_RECRUITING
Troy
North Carolina
Hickory Dermatology Research Center
COMPLETED
Hickory
New Mexico
Albuquerque Clinical Trials, Inc.
ACTIVE_NOT_RECRUITING
Albuquerque
New York
Equity Medical
ACTIVE_NOT_RECRUITING
New York
Icahn School of Medicine at Mount Sinai
ACTIVE_NOT_RECRUITING
New York
Ohio
Dermatologists of Central States, LLC
RECRUITING
Fairborn
Tennessee
ObjectiveHealth - Goodlettsville Dermatology Research
COMPLETED
Goodlettsville
Texas
John Peter Smith Hospital
RECRUITING
Fort Worth
Reveal Research Institute - Frisco
ACTIVE_NOT_RECRUITING
Frisco
Biopharma Informatic, LLC
ACTIVE_NOT_RECRUITING
Houston
Prime Clinical Research - Mansfield
ACTIVE_NOT_RECRUITING
Mansfield
Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue
ACTIVE_NOT_RECRUITING
San Antonio
Utah
Jordan Valley Dermatology & Research Center
ACTIVE_NOT_RECRUITING
South Jordan
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
ACTIVE_NOT_RECRUITING
Buenos Aires
CIPREC
ACTIVE_NOT_RECRUITING
Buenos Aires
CONEXA Investigacion Clinica S.A.
ACTIVE_NOT_RECRUITING
Buenos Aires
DOM Centro de Reumatología
ACTIVE_NOT_RECRUITING
Buenos Aires
Fundación Respirar
ACTIVE_NOT_RECRUITING
Buenos Aires
Instituto de Neumonologia Y Dermatologia
ACTIVE_NOT_RECRUITING
Buenos Aires
Psoriahue
ACTIVE_NOT_RECRUITING
Buenos Aires
Parra Dermatología
ACTIVE_NOT_RECRUITING
Mendoza
INECO Neurociencias Oroño
ACTIVE_NOT_RECRUITING
Rosario
Instituto de Investigaciones Clinicas Rosario
ACTIVE_NOT_RECRUITING
Rosario
Centro de Investigaciones San Miguel
ACTIVE_NOT_RECRUITING
San Miguel
Brazil
AlergoAlpha - Barueri
ACTIVE_NOT_RECRUITING
Barueri
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
ACTIVE_NOT_RECRUITING
Curitiba
Hospital São Lucas da PUCRS
ACTIVE_NOT_RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre
ACTIVE_NOT_RECRUITING
Porto Alegre
IBPClin - Instituto Brasil de Pesquisa Clínica
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Centro de Pesquisas da Clínica IBIS
ACTIVE_NOT_RECRUITING
Salvador
Faculdade de Medicina do ABC
ACTIVE_NOT_RECRUITING
Santo André
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
ACTIVE_NOT_RECRUITING
São José Dos Campos
CEPIC - Centro Paulista de Investigação Clínica
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Brunswick Dermatology Center
RECRUITING
Fredericton
Maritime Dermatology
RECRUITING
Halifax
Lovegrove Dermatology
RECRUITING
London
Skin Care West
RECRUITING
Nanaimo
Kanata Allergy Clinic
RECRUITING
Ottawa
SKiN Centre for Dermatology
RECRUITING
Peterborough
Oak Ridges Aesthetics Centre
RECRUITING
Richmond Hill
Centre de Recherche Saint-Louis
RECRUITING
Sherbrooke
Eternal Springtime Dermatology
RECRUITING
Thunder Bay
North York Research Inc
RECRUITING
Toronto
Puerto Rico
Dr. Samuel Sanchez PSC
ACTIVE_NOT_RECRUITING
Caguas
CMRC Headlands, LLC
ACTIVE_NOT_RECRUITING
San Juan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2026-09
Participants
Target number of participants: 200
Treatments
Experimental: Lebrikizumab
Lebrikizumab administered subcutaneously (SC).
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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