Phase
Condition
Dermatitis, Atopic
Eczema (Atopic Dermatitis - Pediatric)
Skin Infections/disorders
Treatment
Lebrikizumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have chronic atopic dermatitis (AD) (according to American Academy of DermatologyConsensus 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) atscreening and baseline.
Based on investigator judgement, have a history of inadequate response to treatmentwith topical medications, or determination that topical treatments are otherwisemedically inadvisable.
For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) atbaseline.
Exclusion
Exclusion Criteria:
Have an uncontrolled chronic disease that might require multiple intermittent usesof oral corticosteroids at screening (as defined by the investigator).
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma,within 5 years before the screening, except completely treated in situ carcinoma ofthe cervix of completely treated and resolved nonmetastatic squamous or basal cellcarcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Are diagnosed with active endoparasitic infections or at high risk of theseinfections.
Have a known or suspected history of immunosuppression, including history ofinvasive opportunistic infections despite infection resolution; or unusuallyfrequent, recurrent, or prolonged infections, per the investigator's judgment.
Have presence of skin comorbidities that may interfere with study assessments.
Have a severe concomitant illness(es) that in the investigator's judgment wouldadversely affect the participant's participation in the study.
Have had any of the following types of infection within 3 months of screening ordevelop any of these infections during screening:
Serious (requiring hospitalization, and/or intravenous or equivalent oralantibiotic treatment).
Opportunistic - Note: Herpes zoster is considered active and ongoing until allvesicles are dry and crusted over.
Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
Recurring (including, but not limited to, recurring cellulitis and chronicosteomyelitis).
Have an active or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before thebaseline visit or superficial skin infections within 1 week before the baselinevisit.
Have had any prior treatment with a biologic therapy for AD.
Have had treatment with any of the following agents within 4 weeks prior to thebaseline visit:
systemic immunosuppressive or immunomodulating drugs (for example, systemiccorticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,
azathioprine, methotrexate, and other immunosuppressants)
small molecules (for example, Janus kinase inhibitors [topical or systemic]),or
phototherapy and photochemotherapy for AD.
Treatment with B-cell-depleting biologics, including rituximab, within 6 monthsprior to baseline.
Study Design
Connect with a study center
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425BEA
ArgentinaSite Not Available
Psoriahue
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
ArgentinaSite Not Available
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
ArgentinaSite Not Available
Centro de Investigaciones San Miguel
San Miguel, Buenos Aires 1663
ArgentinaSite Not Available
INECO Neurociencias Oroño
Rosario, Santa Fe 2000
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Rosario
Rosario, Santa Fe S2000CVD
ArgentinaSite Not Available
CIPREC
Buenos Aires, 1061
ArgentinaSite Not Available
CONEXA Investigacion Clinica S.A.
Buenos Aires, 1012
ArgentinaSite Not Available
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, C1056ABI
ArgentinaSite Not Available
DOM Centro de Reumatología
Ciudad Autónoma de Buenos Aires, C1111
ArgentinaSite Not Available
Parra Dermatología
Mendoza, 5500
ArgentinaSite Not Available
Centro de Pesquisas da Clínica IBIS
Salvador, Bahia 41820-020
BrazilSite Not Available
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR
Curitiba, Paraná 80230-130
BrazilSite Not Available
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90050-170
BrazilSite Not Available
AlergoAlpha - Barueri
Barueri, São Paulo 06454-010
BrazilSite Not Available
Faculdade de Medicina do ABC
Santo Andre, São Paulo 09060-870
BrazilSite Not Available
Clinica de Alergia Martti Antila
Sorocaba, São Paulo 18040-425
BrazilSite Not Available
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
São José dos Campos, São Paulo 12243-280
BrazilSite Not Available
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180
BrazilSite Not Available
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
BrazilSite Not Available
Dermatology Research Institute
Calgary, Alberta T2J 7E1
CanadaSite Not Available
Skin Physicians Dermatology
Edmonton, Alberta T6W 4V4
CanadaSite Not Available
Skin Care West
Nanaimo, British Columbia V9V 1A3
CanadaSite Not Available
Brunswick Dermatology Center
Fredericton, New Brunswick E3B 1G9
CanadaSite Not Available
Maritime Dermatology
Halifax, Nova Scotia B3K 5R3
CanadaSite Not Available
Lovegrove Dermatology
London, Ontario N6A 5R9
CanadaSite Not Available
Kanata Allergy Clinic
Ottawa, Ontario K2T 0N7
CanadaSite Not Available
SKiN Centre for Dermatology
Peterborough, Ontario K9J 5K2
CanadaSite Not Available
Oak Ridges Aesthetics Centre
Richmond Hill, Ontario L4E 4L6
CanadaSite Not Available
Eternal Springtime Dermatology
Thunder Bay, Ontario P7C 4Y7
CanadaSite Not Available
North York Research Inc
Toronto, Ontario M2N 3A6
CanadaSite Not Available
Centre de Recherche Saint-Louis
Sherbrooke, Quebec J1G 1X9
CanadaSite Not Available
Dr. Samuel Sanchez PSC
Caguas, 00725
Puerto RicoSite Not Available
Caribbean Medical Research Center
San Juan, 00918
Puerto RicoSite Not Available
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama 35203
United StatesSite Not Available
Research Solutions of Arizona
Litchfield Park, Arizona 85340
United StatesSite Not Available
Alliance Dermatology and Mohs Center
Phoenix, Arizona 85032
United StatesSite Not Available
California Dermatology & Clinical Research Institute
Encinitas, California 92024
United StatesSite Not Available
First OC Dermatology Research Inc
Fountain Valley, California 92708
United StatesSite Not Available
Dermatology Research Associates
Los Angeles, California 90045
United StatesActive - Recruiting
NorCal Clinical Research
Rocklin, California 95765
United StatesSite Not Available
Suncoast Research Associates
Doral, Florida 33172
United StatesSite Not Available
Encore Medical Research
Hollywood, Florida 33024
United StatesSite Not Available
Solutions Through Advanced Research
Jacksonville, Florida 32256
United StatesSite Not Available
Health Clinical Research
Miami, Florida 33176
United StatesSite Not Available
Life Arc Research Centers - Miami
Miami, Florida 33126
United StatesActive - Recruiting
MCR Research
Miami, Florida 33126
United StatesSite Not Available
Deluxe Health Center
Miami Lakes, Florida 33014
United StatesActive - Recruiting
Renstar Medical Research
Ocala, Florida 34470
United StatesSite Not Available
Leading Edge Dermatology
Plantation, Florida 33317
United StatesActive - Recruiting
Research Institute of the Southeast
West Palm Beach, Florida 33401
United StatesSite Not Available
Dermatology Affiliates Research Institute
Atlanta, Georgia 30305
United StatesSite Not Available
ObjectiveHealth - Dermatology Affiliates Research Institute
Atlanta, Georgia 30305
United StatesSite Not Available
Revival Research Institute, LLC
Evans, Georgia 30809
United StatesSite Not Available
DeNova Research
Chicago, Illinois 60602
United StatesActive - Recruiting
Southern Indiana Clinical Research Center
Columbus, Indiana 47201
United StatesActive - Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Southern Indiana Clinical Trials
New Albany, Indiana 47150
United StatesActive - Recruiting
Equity Medical - Bowling Green
Bowling Green, Kentucky 42104
United StatesSite Not Available
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Foxhall Research Center
Chevy Chase, Maryland 20815
United StatesSite Not Available
Great Lakes Research Group, Inc.
Bay City, Michigan 48706
United StatesSite Not Available
Revival Research Institute, LLC
Troy, Michigan 48084
United StatesSite Not Available
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102
United StatesSite Not Available
Equity Medical
New York, New York 10023
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Hickory Dermatology Research Center
Hickory, North Carolina 28602
United StatesSite Not Available
Wright State Physicians
Fairborn, Ohio 45324
United StatesSite Not Available
ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072
United StatesSite Not Available
John Peter Smith Hospital
Fort Worth, Texas 76104
United StatesSite Not Available
Reveal Research Institute - Frisco
Frisco, Texas 75033
United StatesSite Not Available
Biopharma Informatic, LLC
Houston, Texas 77084
United StatesActive - Recruiting
Prime Clinical Research - Mansfield
Mansfield, Texas 76063
United StatesSite Not Available
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218
United StatesActive - Recruiting
Jordan Valley Dermatology & Research Center
South Jordan, Utah 84095
United StatesSite Not Available
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