Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AbbVie
Study ID
NCT04195698
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Upadacitinib will be administered oral as tablet

Study Details

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

Key Dates

Start date
Jan 15, 2020
Status verified
Jan 2025
Primary completion
Sep 11, 2023
Completion
Sep 11, 2023

Study Design

Enrollment
475 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib
    Participants will be administered with upadacitinib once daily (QD)

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days). ]

Locations (33)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical Sciences /ID# 221021Little RockArkansas72205-
Duplicate_First OC Dermatology Research Inc /ID# 218619Fountain ValleyCalifornia92708-3701-
UCSF Fresno /ID# 218453FresnoCalifornia93701-2302-
California Allergy and Asthma Medical Group /ID# 218635Los AngelesCalifornia90025-7014-
Dermatology Research Associates /ID# 218637Los AngelesCalifornia90045-
Dermatology Clinical Trials /ID# 218627Newport BeachCalifornia92660-7853-
Duplicate_UC Davis Health /ID# 218582SacramentoCalifornia95816-3300-
Ucsd /Id# 218629San DiegoCalifornia92103-
Clinical Science Institute /ID# 218632Santa MonicaCalifornia90404-2102-
Florida International Rsrch cr /ID# 218663MiamiFlorida33173-
Miami Dermatology and Laser Institute /ID# 218664MiamiFlorida33173-3570-
GCP Research /ID# 218665St. PetersburgFlorida33705-
Clinical Research Trials of Florida, Inc. /ID# 218438TampaFlorida33607-
Georgia Pollens Clinical Research Centers, Inc /ID# 218441AlbanyGeorgia31707-1282-
Medical Dermatology Associates of Chicago /ID# 218551ChicagoIllinois60654-6903-
Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552NormalIllinois61761-
Dawes Fretzin, LLC /ID# 218478IndianapolisIndiana46256-
Beacon Clinical Research, LLC /ID# 218636QuincyMassachusetts02169-
Duplicate_Michigan Center for Research Company /ID# 218577ClarkstonMichigan48346-
Henry Ford Medical Center - New Center One /ID# 218575DetroitMichigan48202-3046-
Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 218548LincolnNebraska68505-2343-
Skin Specialists, PC /ID# 218549OmahaNebraska68144-
University Hospitals Case Medical Center /ID# 218574ClevelandOhio44106-
Southside Dermatology /ID# 218477TulsaOklahoma74132-
Oregon Medical Research Center /ID# 218440PortlandOregon97223-
Oregon Medical Research Center /ID# 218578PortlandOregon97239-
Duplicate_Medical University of South Carolina /ID# 221072CharlestonSouth Carolina29425-
Clinical Research Solutions, LLC /ID# 218447JacksonTennessee38305-2163-
Orion Clinical Research /ID# 218565AustinTexas78759-4100-
Sante Clinical Research /ID# 218911KerrvilleTexas78028-9640-
Clinical Research Partners, LLC /ID# 218480RichmondVirginia23220-4459-
Duplicate_Premier Clinical Research /ID# 218583SpokaneWashington99202-
West Virginia Research Inst /ID# 218479South CharlestonWest Virginia25309-

Find similar trials in Little Rock, AR

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Arkansas for Medical Sciences· Little Rock, ARDuplicate_First OC Dermatology Research Inc· Fountain Valley, CAUCSF Fresno· Fresno, CACalifornia Allergy and Asthma Medical Group· Los Angeles, CADermatology Research Associates· Los Angeles, CADermatology Clinical Trials· Newport Beach, CA

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