A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Tampa, Florida.

Sponsor
AbbVie
Study ID
NCT02925117
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Upadacitinib — DRUG
    Tablet for oral use
  • Placebo — DRUG
    Tablet

Study Details

The objective of this study was to evaluate the safety and efficacy of multiple doses of upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe atopic dermatitis (AD).

Key Dates

Start date
Oct 25, 2016
Status verified
Jul 2020
Primary completion
Aug 10, 2017
Completion
Jan 31, 2019

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants randomized to receive placebo once daily (QD) for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo once a day for 72 weeks in Period 2.
  • Experimental: Upadacitinib 7.5 mg
    Participants randomized to receive upadacitinib 7.5 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 7.5 mg upadacitinib or placebo QD for 72 weeks in Period 2.
  • Experimental: Upadacitinib 15 mg
    Participants randomized to receive upadacitinib 15 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 15 mg upadacitinib or placebo QD for 72 weeks in Period 2.
  • Experimental: Upadacitinib 30 mg
    Participants randomized to receive upadacitinib 30 mg QD for 16 weeks in Period 1. At Week 16 participants were re-randomized to receive 30 mg upadacitinib or placebo QD for 72 weeks in Period 2.

Primary Outcome Measure

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (10)

FacilityCityStateZIPSite coordinators
ForCare Clinical Research /ID# 157974TampaFlorida33613-1244-
Advanced Medical Research /ID# 154516Sandy SpringsGeorgia30328-6141-
DermAssociates /ID# 153584RockvilleMaryland20850-
Tufts Medical Center /ID# 153586BostonMassachusetts02111-
Psoriasis Treatment Ctr NJ /ID# 153578East WindsorNew Jersey08520-
Icahn School of Med Mt. Sinai /ID# 153582New YorkNew York10029-
Univ Rochester Med Ctr /ID# 154477RochesterNew York14642-
Arlington Research Center, Inc /ID# 154522ArlingtonTexas76011-
Modern Research Associates, PL /ID# 154487DallasTexas75231-
Center for Clinical Studies /ID# 153589HoustonTexas77004-

Find similar trials in Tampa, FL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
ForCare Clinical Research· Tampa, FLAdvanced Medical Research· Sandy Springs, GADermAssociates· Rockville, MDTufts Medical Center· Boston, MAPsoriasis Treatment Ctr NJ· East Windsor, NJIcahn School of Med Mt. Sinai· New York, NY

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