A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03435081
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.

Key Dates

Start date
Feb 20, 2018
Status verified
Aug 2022
Primary completion
Dec 9, 2019
Completion
Aug 16, 2021

Study Design

Enrollment
440 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 milligram (mg) Baricitinib
    2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
  • Experimental: 1 mg Baricitinib
    1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
  • Placebo Comparator: Placebo
    Placebo administered orally every day.

Primary Outcome Measure

Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib) [ Time Frame: Week 16 ]

Locations (60)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Johnson DermatologyFort SmithArkansas72916-
Wallace Medical Group, Inc.Beverly HillsCalifornia90211-
California Dermatology and Clinical Research InstituteEncinitasCalifornia92024-
Tien Q. Nguyen, MD inc. DBA First OC DermatologyFountain ValleyCalifornia92708-
Center for Dermatology Clinical Research, Inc.FremontCalifornia94538-
Keck School of Medicine University of Southern CaliforniaLos AngelesCalifornia90033-
University of California Davis-DermatologySacramentoCalifornia95816-
Medical Center for Clinical ResearchSan DiegoCalifornia92108-
University Clinical Trials, Inc.San DiegoCalifornia92123-
Southern California DermatologySanta AnaCalifornia92701-
Clinical Science InstituteSanta MonicaCalifornia90404-
Care Access Research-Walnut CreekWalnut CreekCalifornia94598-
Clinical Research Center of CT/NYDanburyConnecticut06810-
Univ of ConnecticutFarmingtonConnecticut06032-
GWU/Medical Faculty AssociatesWashington D.C.District of Columbia20037-
Solutions Through Advanced Research, Inc.JacksonvilleFlorida32256-
Olympian Clinical ResearchLargoFlorida33770-
Miami Dermatology & Laser ResearchMiamiFlorida33173-
Riverchase Dermatology and Cosmetic SurgeryPembroke PinesFlorida33028-
ForCare Clinical ResearchTampaFlorida33613-
University of South FloridaTampaFlorida33612-
Dermatologic Surgery Specialists, PCMaconGeorgia31217-
Advanced Medical ResearchSandy SpringsGeorgia30328-
Meridian Clinical ResearchSavannahGeorgia31406-
Treasure Valley DermatologyBoiseIdaho83713-
Northwestern UniversityChicagoIllinois60611-
University DermatologyDarienIllinois60561-
Arlington DermatologyRolling MeadowsIllinois60008-
Dawes Fretzin Clinical ResearchIndianapolisIndiana46250-
The Indiana Clinical Trials Center, PCPlainfieldIndiana46168-
The South Bend ClinicSouth BendIndiana46617-
Dermatology SpecialistLouisvilleKentucky40241-
Dermatology and Skin Cancer SpecialistsRockvilleMaryland20850-
Brigham and Womens HospitalBostonMassachusetts02115-
Tufts Medical CenterBostonMassachusetts02111-
Great Lakes Research Group, Inc.Bay CityMichigan48706-
Hamzavi DermatologyFort GratiotMichigan48059-
Central Dermatology PCSt LouisMissouri63117-
Skin Specialists, P.COmahaNebraska68144-
Icahn School of Medicine at Mount SinaiNew YorkNew York10003-
DermResearchCenter of New York, IncStony BrookNew York11790-
Bexley Dermatology ResearchBexleyOhio43209-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Wright State Univ School of MedicineFairbornOhio45324-
Dermatologists of Southwest Ohio, Inc.MasonOhio45040-
OHSU Center for Health and HealingPortlandOregon97239-
Oregon Dermatology and Research CenterPortlandOregon97210-
Dermatology and Skin Surgery CenterExtonPennsylvania19341-
Clinical Partners LLCJohnstonRhode Island02919-
Dermatology & Laser Center of CharlestonCharlestonSouth Carolina29407-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Bellaire DermatologyBellaireTexas77401-
Modern Research Associates PLLCDallasTexas75231-
Austin Institute for Clinical Research, Inc.PflugervilleTexas78660-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Acclaim Dermatology, PLLCSugar LandTexas77497-
University of Utah MidValley DematologyMurrayUtah84107-
Virginia Clinical ResearchNorfolkVirginia23502-
Multicare Health SystemTacomaWashington98405-

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