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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03559270
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

This open-label study will evaluate the long-term efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis (AD).

Key Dates

Start date
Jun 27, 2018
Status verified
Oct 2022
Primary completion
Oct 14, 2021
Completion
Jun 13, 2022

Study Design

Enrollment
374 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo/Baricitinib 2-milligram (mg)
    Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
  • Experimental: Baricitinib 1-mg/Baricitinib 2-mg
    Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
  • Experimental: Baricitinib 2-mg/Baricitinib 2-mg
    Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
  • Experimental: Baricitinib 2-mg Open-Label Addendum
    Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.

Primary Outcome Measure

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

Locations (53)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Johnson DermatologyFort SmithArkansas72916-
California Dermatology & Clinical Research InstituteEncinitasCalifornia92024-
First OC DermatologyFountain ValleyCalifornia92708-
Center For Dermatology Clinical Research, Inc.FremontCalifornia94538-
Keck School of Medicine University of Southern CaliforniaLos AngelesCalifornia90033-
Wallace Medical Group, Inc.Los AngelesCalifornia90056-
University of California Davis-DermatologySacramentoCalifornia95816-
Medical Center For Clinical ResearchSan DiegoCalifornia92108-
University Clinical Trials, Inc.San DiegoCalifornia92123-
Southern California Dermatology, Inc.Santa AnaCalifornia92701-
Clinical Science InstituteSanta MonicaCalifornia90404-
Care Access Research-Walnut CreekWalnut CreekCalifornia94598-
GWU/Medical Faculty AssociatesWashington D.C.District of Columbia20037-
Solutions Through Advanced Research, Inc.JacksonvilleFlorida32256-
Olympian Clinical ResearchLargoFlorida33770-
Miami Dermatology and Laser ResearchMiamiFlorida33173-
Riverchase Dermatology and Cosmetic SurgeryPembroke PinesFlorida33028-
ForCare Clinical ResearchTampaFlorida33613-1244-
University of South FloridaTampaFlorida33612-
Dermatologic Surgery Specialists, PCMaconGeorgia31217-
Advanced Medical ResearchSandy SpringsGeorgia30328-
Advanced Clinical Research LLCMeridianIdaho83642-
Northwestern UniversityChicagoIllinois60611-
University DermatologyDarienIllinois60561-
Arlington DermatologyRolling MeadowsIllinois60008-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
The Indiana Clinical Trials CenterPlainfieldIndiana46168-
The South Bend Clinic Center for ResearchSouth BendIndiana46617-
Forefront ResearchLouisvilleKentucky40241-
Dermatology and Skin Cancer SpecialistsRockvilleMaryland20850-
Brigham and Women's HospitalBostonMassachusetts02115-
Tufts Medical CenterBostonMassachusetts02111-
Great Lakes Research Group, Inc.Bay CityMichigan48706-
Central Dermatology PCSt LouisMissouri63117-
Skin Specialists, P.COmahaNebraska68144-
Icahn Sch of Med at Mt. SinaiNew YorkNew York10003-
DermResearchCenter of New York, IncStony BrookNew York11790-
Bexley Dermatology ResearchBexleyOhio43209-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Wright State Univ School of MedicineFairbornOhio45324-
OHSU Center for Health and HealingPortlandOregon97239-
Oregon Dermatology and Research CenterPortlandOregon97210-
The Pennsylvania Centre for Dermatology, LLCExtonPennsylvania19341-
Clinical Partners, LLCJohnstonRhode Island02919-
Clinical Research Center of the CarolinasCharlestonSouth Carolina29407-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Bellaire DermatologyBellaireTexas77401-
Modern Research AssociatesDallasTexas75231-
Austin Institute for Clinical ResearchPflugervilleTexas78660-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
University of Utah MidValley DematologyMurrayUtah84107-
MultiCare Good Samaritan HospitalTacomaWashington98405-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, ALJohnson Dermatology· Fort Smith, ARCalifornia Dermatology & Clinical Research Institute· Encinitas, CAFirst OC Dermatology· Fountain Valley, CACenter For Dermatology Clinical Research, Inc.· Fremont, CAKeck School of Medicine University of Southern California· Los Angeles, CA

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