Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Part of paid clinical trials in Irvine, California.

Sponsor
AbbVie
Study ID
NCT04927975
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed. Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide. Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date
Jun 30, 2021
Status verified
Sep 2024
Primary completion
Jan 13, 2023
Completion
Aug 29, 2023

Study Design

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

Arms

  • Experimental: Upa 22 mg Period 1, then Upa 22 mg Period 2
    Participants received upadacitinib 22 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
  • Experimental: Upa 11 mg Period 1, then Upa 11 mg Period 2
    Participants received upadacitinib 11 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
  • Experimental: Upa 6 mg Period 1, then Upa 6 mg Period 2
    Participants received upadacitinib 6 mg administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 6 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
  • Experimental: Placebo Period 1, then Upa 22 mg Period 2
    Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 22 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.
  • Experimental: Placebo Period 1, then Upa 11 mg Period 2
    Participants received Placebo for upadacitinib administered orally once a day (QD) as tablets for 24 weeks during Period 1. Participants then received upadacitinib 11 mg administered orally once a day (QD) as tablets for 28 weeks during Period 2.

Primary Outcome Measure

Percent Change From Baseline in Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (20)

FacilityCityStateZIPSite coordinators
University of California Irvine /ID# 229390IrvineCalifornia92697-1385-
Stanford University /ID# 228000Redwood CityCalifornia94063-
Clearlyderm Dermatology /ID# 227993Boca RatonFlorida33428-
New Horizon Research Center /ID# 229403MiamiFlorida33165-3372-
Park Avenue Dermatology, PA /ID# 229400Orange ParkFlorida32073-
ForCare Clinical Research /ID# 228010TampaFlorida33613-1244-
Dawes Fretzin, LLC /ID# 227996IndianapolisIndiana46256-
Tufts Medical Center /ID# 228087BostonMassachusetts02111-1552-
Duplicate_UMass Chan Medical School /ID# 228066WorcesterMassachusetts01655-
Duplicate_Michigan Center for Research Company /ID# 228054ClarkstonMichigan48346-
Hamzavi Dermatology /ID# 228056Fort GratiotMichigan48059-
Remington-Davis Clinical Research /ID# 229401ColumbusOhio43215-
Essential Medical Research, LLC /ID# 228074TulsaOklahoma74137-2842-
Oregon Dermatology and Research Center /ID# 228007PortlandOregon97210-
Oregon Medical Research Center /ID# 228073PortlandOregon97223-
Duplicate_Medical University of South Carolina /ID# 228067CharlestonSouth Carolina29425-
International Clinical Research - Tennessee LLC /ID# 228059MurfreesboroTennessee37130-2450-
Bellaire Dermatology Associates /ID# 228004BellaireTexas77401-
University of Texas Health Science Center at Houston /ID# 229399HoustonTexas77030-1501-
Virginia Clinical Research, Inc. /ID# 228050NorfolkVirginia23502-

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University of California Irvine· Irvine, CAStanford University· Redwood City, CAClearlyderm Dermatology· Boca Raton, FLNew Horizon Research Center· Miami, FLPark Avenue Dermatology, PA· Orange Park, FLForCare Clinical Research· Tampa, FL

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