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Active, not recruitingPhase 3

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Key facts

Who runs it
AbbVie
Where
Auburn Hills, Bay City, Bellaire, Boca Raton, Boston, Brandon, Canton, Charleston, Chicago, Clarkston, Columbus, Coral Gables, Dallas, Dawsonville, Detroit, Encino, Glendale, Hialeah, Hollywood, Indianapolis, Irvine, Las Vegas, Los Angeles, Margate, Miami Lakes, New Brighton, New York, Phoenix, Plano, Portland, Redwood City, Sacramento, San Antonio, Stony Brook, Tampa, Thousand Oaks, Weston, and Worcester, United StatesSee the 46 sitesAlso in 18 other countries, 106 sites
Status
Active, not recruiting
Phase
Phase 3
People taking part
614 people enrolled
Started
19 Dec 2023
Expected to end
Mar 2028
Type of study
Interventional, 12 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Upadacitinib
  • Placebo
  • NB-UVB (narrow-band ultraviolet B) Phototherapy
Record updated
9 June 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Documented clinical diagnosis of non-segmented vitiligo (NSV)
  • At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:; >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or; >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have a sign of actively progressing vitiligo; or; >= 0.5 F-VASI and 10 <= T-VASI < 50

Who cannot take part

  • History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo
  • Segmental or localized vitiligo
  • >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face)

Where in United States

Also in 18 other countries, 106 sites

  • Oakland Hills Dermatology /ID# 260602Auburn Hills, United StatesNo longer taking part
  • Great Lakes Research Group - Bay City /ID# 260600Bay City, United StatesNo longer taking part
  • Bellaire Dermatology Associates /ID# 260044Bellaire, United StatesNo longer taking part
  • Skin Care Research Boca Raton /ID# 260094Boca Raton, United StatesNo longer taking part
  • Tufts Medical Center. /ID# 260088Boston, United StatesNo longer taking part
  • Apex Clinical Trials /ID# 260096Brandon, United StatesNo longer taking part
  • Hamzavi Dermatology - Canton /ID# 260545Canton, United StatesNo longer taking part
  • Medical University of South Carolina /ID# 259916Charleston, United StatesNo longer taking part
  • DeNova Research /ID# 260611Chicago, United StatesNo longer taking part
  • Clarkston Dermatology /ID# 260069Clarkston, United StatesNo longer taking part
  • ClinOhio Research Services /ID# 260300Columbus, United StatesNo longer taking part
  • Florida Academic Dermatology Center /ID# 259919Coral Gables, United StatesNo longer taking part
  • Dermatology Treatment and Research Center /ID# 260078Dallas, United StatesNo longer taking part
  • Cleaver Medical Group Dermatology /ID# 259925Dawsonville, United StatesNo longer taking part
  • Henry Ford Medical Center - New Center One /ID# 260059Detroit, United StatesNo longer taking part
  • Private Practice - Dr. Tooraj Raoof /ID# 260055Encino, United StatesNo longer taking part
  • Advanced Research Associates - Glendale /ID# 259915Glendale, United StatesNo longer taking part
  • Direct Helpers Research Center /ID# 259932Hialeah, United StatesNo longer taking part
  • Encore Medical Research /ID# 259963Hollywood, United StatesNo longer taking part
  • Skin Care Research - Hollywood /ID# 260101Hollywood, United StatesNo longer taking part
  • Dawes Fretzin /ID# 260068Indianapolis, United StatesNo longer taking part
  • Indiana University Health University Hospital /ID# 259974Indianapolis, United StatesNo longer taking part
  • University of California Irvine /ID# 260080Irvine, United StatesNo longer taking part
  • Vivida Dermatology- Flamingo /ID# 260609Las Vegas, United StatesNo longer taking part
  • Dermatology Research Associates /ID# 260056Los Angeles, United StatesNo longer taking part
  • Vitiligo & Pigmentation Institute of Southern California /ID# 259970Los Angeles, United StatesNo longer taking part
  • GSI Clinical Research, LLC /ID# 259918Margate, United StatesNo longer taking part
  • Life Clinical Trials - N State Rd - Margate /ID# 260097Margate, United StatesNo longer taking part
  • Savin Medical Group, LLC /ID# 259968Miami Lakes, United StatesNo longer taking part
  • Minnesota Clinical Study Center /ID# 260154New Brighton, United StatesNo longer taking part
  • Icahn School of Medicine at Mount Sinai /ID# 259909New York, United StatesNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 260152New York, United StatesNo longer taking part
  • Alliance Dermatology and Mohs Center /ID# 259926Phoenix, United StatesNo longer taking part
  • Innovative Dermatology - Plano /ID# 260628Plano, United StatesNo longer taking part
  • Oregon Dermatology and Research Center /ID# 259917Portland, United StatesNo longer taking part
  • Oregon Medical Research Center /ID# 259911Portland, United StatesNo longer taking part
  • Duplicate_Stanford University /ID# 260081Redwood City, United StatesNo longer taking part
  • Integrative Skin Science and Research /ID# 260060Sacramento, United StatesNo longer taking part
  • University of California Davis Health /ID# 260062Sacramento, United StatesNo longer taking part
  • Dermatology Clinical Research Center of San Antonio /ID# 260047San Antonio, United StatesNo longer taking part
  • Progressive Clinical Research /ID# 260070San Antonio, United StatesNo longer taking part
  • DermResearchCenter of New York, Inc. /ID# 259906Stony Brook, United StatesNo longer taking part
  • Advanced Clinical Research Institute - Tampa /ID# 260058Tampa, United StatesNo longer taking part
  • Clinical Trials Research Institute /ID# 259910Thousand Oaks, United StatesNo longer taking part
  • Encore Medical Research - Weston /ID# 260542Weston, United StatesNo longer taking part
  • UMass Memorial Medical Center - Lake Avenue North /ID# 259921Worcester, United StatesNo longer taking part

About the trial

What the trial wants to find out

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 (NSV). Adverse effects and change in disease activity will be assessed.

Read full original descriptionShow less

Upadacitinib is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4.

In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks.

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.

The 12 groups in the trial

  • Study 1, Period A: Group 1Treatment being tested

    Participants will receive upadacitinib 15 mg once daily for 48 weeks.

    Treatment: Upadacitinib

  • Study 1, Period A: Group 2Placebo, for comparison

    Participants will receive placebo once daily for 48 weeks.

    Treatment: Placebo

  • Study 2, Period A: Group 1Treatment being tested

    Participants will receive upadacitinib 15 mg once daily for 48 weeks.

    Treatment: Upadacitinib

  • Study 2, Period A: Group 2Placebo, for comparison

    Participants will receive placebo once daily for 48 weeks.

    Treatment: Placebo

  • Study 1, Period B: Group 1 Open-Label Extension PeriodTreatment being tested

    Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

    Treatment: Upadacitinib

  • Study 1, Period B: Group 2 Open-Label Extension PeriodTreatment being tested

    Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

    Treatment: Upadacitinib

  • Study 2, Period B: Group 1 Open-Label Extension PeriodTreatment being tested

    Participants that were randomized to receive upadacitinib in Period A Group 1, will continue to receive upadacitinib 15 mg once daily for 112 weeks in Period B.

    Treatment: Upadacitinib

  • Study 2, Period B: Group 2 Open-Label Extension PeriodTreatment being tested

    Participants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.

    Treatment: Upadacitinib

  • (Optional) Study 3: Open Label UpadacitinibTreatment being tested

    Participants will receive upadacitinib 15 mg once daily for 112 weeks.

    Treatment: Upadacitinib and NB-UVB (narrow-band ultraviolet B) Phototherapy

  • (Optional) Study 3: Open Label Upadacitinib + NB-UVBTreatment being tested

    Participants will receive 15 mg upadacitinib once daily for 112 weeks and Narrow-band ultraviolet B (NB-UVB) for up to 28 weeks.

    Treatment: Upadacitinib and NB-UVB (narrow-band ultraviolet B) Phototherapy

  • Study 4: Upadacitinib 15 mgTreatment being tested

    Eligible participants will be re-randomized to receive upadacitinib 15 mg once daily for 56 weeks.

    Treatment: Upadacitinib

  • Study 4: Upadacitinib 30 mgTreatment being tested

    Eligible participants will be re-randomized to receive upadacitinib 30 mg once daily for 56 weeks.

    Treatment: Upadacitinib

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Publications
Record updated
9 June 2026