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AzTrials

VitiligoPhase 3Viti-UpNCT06118411

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

A Phase 3 study testing Upadacitinib and NB-UVB (narrow-band ultraviolet B) Phototherapy in people with Vitiligo, run by AbbVie at 148 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Vitiligo
What is being tested?
Upadacitinib and NB-UVB (narrow-band ultraviolet B) Phototherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
614 participants
Where
148 sitesin 19 countries
Study dates
19 Dec 2023to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 join

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

Trial locations and contacts

148 sites in 19 countries.

148 sites in 19 countries

United States46 sites

  • Oakland Hills Dermatology /ID# 260602

    Auburn Hills, Michigan, 48326

  • Great Lakes Research Group - Bay City /ID# 260600

    Bay City, Michigan, 48706

  • Bellaire Dermatology Associates /ID# 260044

    Bellaire, Texas, 77401

  • Skin Care Research Boca Raton /ID# 260094

    Boca Raton, Florida, 33486-2269

  • Tufts Medical Center. /ID# 260088

    Boston, Massachusetts, 02111-1552

  • Apex Clinical Trials /ID# 260096

    Brandon, Florida, 33511

  • Hamzavi Dermatology - Canton /ID# 260545

    Canton, Michigan, 48187

  • Medical University of South Carolina /ID# 259916

    Charleston, South Carolina, 29425

  • DeNova Research /ID# 260611

    Chicago, Illinois, 60610

  • Clarkston Dermatology /ID# 260069

    Clarkston, Michigan, 48346

  • ClinOhio Research Services /ID# 260300

    Columbus, Ohio, 43213-4440

  • Florida Academic Dermatology Center /ID# 259919

    Coral Gables, Florida, 33134-5755

  • Dermatology Treatment and Research Center /ID# 260078

    Dallas, Texas, 75230

  • Cleaver Medical Group Dermatology /ID# 259925

    Dawsonville, Georgia, 30534

  • Henry Ford Medical Center - New Center One /ID# 260059

    Detroit, Michigan, 48202-3046

  • Private Practice - Dr. Tooraj Raoof /ID# 260055

    Encino, California, 91436

  • Advanced Research Associates - Glendale /ID# 259915

    Glendale, Arizona, 85308

  • Direct Helpers Research Center /ID# 259932

    Hialeah, Florida, 33012

  • Skin Care Research - Hollywood /ID# 260101

    Hollywood, Florida, 33021-6748

  • Encore Medical Research /ID# 259963

    Hollywood, Florida, 33021

  • Indiana University Health University Hospital /ID# 259974

    Indianapolis, Indiana, 46202

  • Dawes Fretzin /ID# 260068

    Indianapolis, Indiana, 46256

  • University of California Irvine /ID# 260080

    Irvine, California, 92697-1385

  • Vivida Dermatology- Flamingo /ID# 260609

    Las Vegas, Nevada, 89119-5190

  • Vitiligo & Pigmentation Institute of Southern California /ID# 259970

    Los Angeles, California, 90036-5679

  • Dermatology Research Associates /ID# 260056

    Los Angeles, California, 90045

  • GSI Clinical Research, LLC /ID# 259918

    Margate, Florida, 33063

  • Life Clinical Trials - N State Rd - Margate /ID# 260097

    Margate, Florida, 33063

  • Savin Medical Group, LLC /ID# 259968

    Miami Lakes, Florida, 33014

  • Minnesota Clinical Study Center /ID# 260154

    New Brighton, Minnesota, 55112

  • Schweiger Dermatology, P.C. /ID# 260152

    New York, New York, 07044-2946

  • Icahn School of Medicine at Mount Sinai /ID# 259909

    New York, New York, 10029

  • Alliance Dermatology and Mohs Center /ID# 259926

    Phoenix, Arizona, 85032

  • Innovative Dermatology - Plano /ID# 260628

    Plano, Texas, 75024

  • Oregon Medical Research Center /ID# 259911

    Portland, Oregon, 97201

  • Oregon Dermatology and Research Center /ID# 259917

    Portland, Oregon, 97210

  • Duplicate_Stanford University /ID# 260081

    Redwood City, California, 94063

  • Integrative Skin Science and Research /ID# 260060

    Sacramento, California, 95815

  • University of California Davis Health /ID# 260062

    Sacramento, California, 95817

  • Dermatology Clinical Research Center of San Antonio /ID# 260047

    San Antonio, Texas, 78229

  • Progressive Clinical Research /ID# 260070

    San Antonio, Texas, 78229

  • DermResearchCenter of New York, Inc. /ID# 259906

    Stony Brook, New York, 11790

  • Advanced Clinical Research Institute - Tampa /ID# 260058

    Tampa, Florida, 33607

  • Clinical Trials Research Institute /ID# 259910

    Thousand Oaks, California, 91320-2130

  • Encore Medical Research - Weston /ID# 260542

    Weston, Florida, 33331

  • UMass Memorial Medical Center - Lake Avenue North /ID# 259921

    Worcester, Massachusetts, 01655

Other trials in United States

China15 sites

  • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 260919

    Beijing, Beijing Municipality, 100730

  • Chengdu Second Municipal People's Hospital /ID# 260423

    Chengdu, Sichuan, 610017

  • West China Hospital, Sichuan University /ID# 260624

    Chengdu, Sichuan, 610041

  • Dermatology Hospital of Southern Medical University /ID# 260136

    Guangzhou, Guangdong, 510091

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 259929

    Guangzhou, Guangdong, 510260

  • Hangzhou Third People'S Hospital /ID# 261005

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260626

    Hangzhou, Zhejiang, 310020

  • Shandong Dermatological Hospital /ID# 260338

    Jinan, Shandong, 250022

  • First Affiliated Hospital of Kunming Medical University /ID# 260017

    Kunming, Yunnan, 650032

  • Huashan Hospital, Fudan University /ID# 259823

    Shanghai, Shanghai Municipality, 200040

  • Tianjin Medical University General Hospital /ID# 259812

    Tianjin, Tianjin Municipality, 300052

  • The First Affiliated Hospital of Wenzhou Medical University /ID# 259822

    Wenzhou, Zhejiang, 325000

  • Renmin Hospital of Wuhan University /ID# 260477

    Wuhan, Hubei, 430060

  • Second Affiliated Hospital of Xian Jiaotong University /ID# 260011

    Xi'an, Shaanxi, 710004

  • The First Affiliated Hospital of Xi'an Jiaotong University /ID# 260340

    Xi'an, Shaanxi, 710061

Other trials in China

Germany11 sites

  • Fachklinik Bad Bentheim /ID# 260293

    Bad Bentheim, Lower Saxony, 48455

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 260294

    Berlin, 10117

  • Dermatologie Mahlow /ID# 260148

    Blankenfelde-Mahlow, Brandenburg, 15831

  • MVZ Dermatologisches Zentrum Bonn GmbH /ID# 260287

    Bonn, Hesse, 53111

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 260289

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen /ID# 260153

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Frankfurt /ID# 260288

    Frankfurt am Main, Hesse, 60590

  • Private Practice - Dr. Abdou Zarzour /ID# 260290

    Halle, Saxony-Anhalt, 06108

  • Universitaetsmedizin Mainz /ID# 260151

    Mainz, Rhineland-Palatinate, 55131

  • TUM Klinikum rechts der Isar /ID# 260291

    Munich, Bavaria, 81675

  • Universitaetsklinikum Muenster /ID# 260147

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Poland10 sites

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 259753

    Bialystok, Podlaskie Voivodeship, 15-351

  • Centrum Medyczne Angelius Provita /ID# 259752

    Katowice, Silesian Voivodeship, 40-615

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy /ID# 260016

    Krakow, Lesser Poland Voivodeship, 30-002

  • Malopolskie Centrum Kliniczne /ID# 259686

    Krakow, Lesser Poland Voivodeship, 30-149

  • Krakowskie Centrum Medyczne /ID# 261424

    Krakow, Lesser Poland Voivodeship, 31-501

  • Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski /ID# 259690

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • Twoja Przychodnia SCM /ID# 259757

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Klinika Osipowicz & Turkowski sp.z.o.o /ID# 259761

    Warsaw, Masovian Voivodeship, 00-716

  • Klinika Ambroziak Dermatologia /ID# 260018

    Warsaw, Masovian Voivodeship, 02-953

  • Royalderm Agnieszka Nawrocka /ID# 259691

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Canada8 sites

  • Dermatology Research Institute - Blackfoot Trail /ID# 261175

    Calgary, Alberta, T2J 7E1

  • Brunswick Dermatology Center /ID# 260237

    Fredericton, New Brunswick, R3M 3Z4

  • LEADER Research /ID# 260407

    Hamilton, Ontario, L8L 3C3

  • Centre de Recherche dermatologique du Quebec Metropolitain /ID# 260241

    Québec, Quebec, G1V 4X7

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 260238

    Saint-Jérôme, Quebec, J7Z 7E2

  • Dr. Chih-ho Hong Medical Inc. /ID# 260239

    Surrey, British Columbia, V3R 6A7

  • Private Practice - Dr. Kim Papp Clinical Research /ID# 260406

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research /ID# 260236

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Japan7 sites

  • Nippon Medical School Hospital /ID# 260550

    Bunkyo-ku, Tokyo, 113-8603

  • Yamanashi Prefectural Central Hospital /ID# 260554

    Kofu, Yamanashi, 400-8506

  • Nagoya City University Hospital /ID# 260551

    Nagoya, Aichi-ken, 467-8602

  • Dermatology and Ophthalmology Kume Clinic /ID# 260555

    Sakai-shi, Osaka, 593-8324

  • Tokyo Medical University Hospital /ID# 260552

    Shinjuku-ku, Tokyo, 160-0023

  • The University of Osaka Hospital /ID# 261285

    Suita-shi, Osaka, 565-0871

  • Yamagata University Hospital /ID# 260553

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Spain7 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 259371

    Badalona, Barcelona, 08916

  • Hospital Universitario de Getafe /ID# 259376

    Getafe, Madrid, 28905

  • Hospital Universitario Clinico San Cecilio /ID# 259374

    Granada, 18016

  • Grupo Pedro Jaen /ID# 259375

    Madrid, 28006

  • Hospital Universitario Quironsalud Madrid /ID# 259377

    Pozuelo de Alarcón, Madrid, 28223

  • Consorci Hospital General Universitario de Valencia /ID# 259372

    Valencia, 46014

  • Hospital Clinico Universitario Lozano Blesa /ID# 259373

    Zaragoza, 50009

Other trials in Spain

Argentina6 sites

  • Centro de Investigacion y Prevencion Cardiovascular (CIPREC) /ID# 259889

    Buenos Aires, 1061

  • Buenos Aires Skin /ID# 259885

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1055

  • Instituto de Neumonologia y Dermatologia /ID# 259888

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Psoriahue Med Interdisciplinar /ID# 259890

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1425

  • Instituto De Investigaciones Clínicas Córdoba /ID# 260371

    Córdoba, Córdoba Province, 5000

  • Sanatorio 9 de Julio /ID# 260245

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

France5 sites

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-Andre /ID# 259443

    Bordeaux, Gironde, 33000

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259446

    Créteil, Paris, 94010

  • HCL - Hopital Edouard Herriot /ID# 259444

    Lyon, Rhone, 69003

  • Chu de Nice-Hopital Larchet Ii /Id# 259442

    Nice, Alpes-Maritimes, 06202

  • CHU Toulouse - Hopital Larrey /ID# 259445

    Toulouse, Haute-Garonne, 31400

Other trials in France

Israel5 sites

  • Rambam Health Care Campus /ID# 259852

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 259849

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 260420

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 259851

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 259850

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

South Korea5 sites

  • Soon Chun Hyang University Hospital Bucheon /ID# 260836

    Bucheon-si, Gyeonggido, 14584

  • Chungnam National University Hospital /ID# 260917

    Daejeon, Daejeon Gwang Yeogsi, 35015

  • Kyung Hee University Hospital at Gangdong /ID# 260879

    Seoul, Seoul Teugbyeolsi, 05278

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 260880

    Suwon, Gyeonggido, 16247

  • Ajou University Hospital - Suwon-si /ID# 260916

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Belgium4 sites

  • Cliniques Universitaires UCL Saint-Luc /ID# 259429

    Brussels, Brussels Capital, 1200

  • Grand Hopital de Charleroi - Les Viviers /ID# 259437

    Charleroi, Hainaut, 6280

  • UZ Gent /ID# 259430

    Ghent, Oost-Vlaanderen, 9000

  • CHU de Liege /ID# 259427

    Liège, 4000

Other trials in Belgium

Bulgaria4 sites

  • Medical Center Cordis /ID# 259954

    Pleven, 5800

  • Ambulatory for Specialized Medical Care-IPSMC-skin and venereal diseases /ID# 259955

    Sofiya, Sofia, 1407

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 259956

    Sofiya, Sofia, 1463

  • Diagnosis - Consult Centre 20 - Sofia /ID# 259953

    Sofiya, Sofia, 1618

Other trials in Bulgaria

Portugal4 sites

  • Unidade Local de Saude de Coimbra /ID# 259793

    Coimbra, 3000-075

  • Unidade Local de Saude da Regiao de Leiria /ID# 259789

    Leiria, 2410-197

  • Hospital CUF Descobertas /ID# 259788

    Lisbon, 1998-018

  • Unidade Local de Saude de Santo Antonio /ID# 259791

    Porto, 4099-003

Other trials in Portugal

Netherlands3 sites

  • Amsterdam UMC, locatie AMC /ID# 259676

    Amsterdam, North Holland, 1105 AZ

  • Bravis Ziekenhuis /ID# 259501

    Bergen op Zoom, North Brabant, 4624 VT

  • Amphia Ziekenhuis /ID# 259696

    Breda, North Brabant, 4818 CK

Other trials in Netherlands

Puerto Rico3 sites

  • Santa Cruz Behavioral (SCB) Research Center /ID# 260100

    Bayamón, 00961-6910

  • Dr. Samuel Sanchez PSC /ID# 260090

    Caguas, 00727

  • Mindful Medical Research /ID# 260092

    San Juan, 00918-3756

Other trials in Puerto Rico

Italy2 sites

  • ASST degli Spedali Civili di Brescia /ID# 259772

    Brescia, 25123

  • IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 259771

    Rome, Roma, 00144

Other trials in Italy

Slovakia2 sites

  • Derma therapy spol /ID# 260838

    Bratislava, Bratislava Region, 851 01

  • Fakultna nemocnica Trnava /ID# 260164

    Trnava, 917 02

Other trials in Slovakia

Hungary1 site

  • DERMA-B Egeszsegugyi es Szolgaltato - Debrecen - Gyepusor Utca /ID# 260072

    Debrecen, 4031

Other trials in Hungary

About this study

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

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.

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.

Read more

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.

Conditions
Vitiligo
Being tested
Upadacitinib, Placebo, NB-UVB (narrow-band ultraviolet B) Phototherapy
Keywords
Vitiligo, Non-Segmented Vitiligo, Viti-Up, Upadacitinib
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpadacitinibDrug

    Also called ABT-494, Rinvoq

    Oral Tablets

  • PlaceboDrug

    Oral Tablets

  • NB-UVB (narrow-band ultraviolet B) PhototherapyOther

    NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week

Study groups in NCT06118411
Study groupRoleWhat they receive
Study 1, Period A: Group 1ExperimentalParticipants will receive upadacitinib 15 mg once daily for 48 weeks.
Receives: Drug: Upadacitinib
Study 1, Period A: Group 2Placebo comparatorParticipants will receive placebo once daily for 48 weeks.
Receives: Drug: Placebo
Study 2, Period A: Group 1ExperimentalParticipants will receive upadacitinib 15 mg once daily for 48 weeks.
Receives: Drug: Upadacitinib
Study 2, Period A: Group 2Placebo comparatorParticipants will receive placebo once daily for 48 weeks.
Receives: Drug: Placebo
Study 1, Period B: Group 1 Open-Label Extension PeriodExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Study 1, Period B: Group 2 Open-Label Extension PeriodExperimentalParticipants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
Receives: Drug: Upadacitinib
Study 2, Period B: Group 1 Open-Label Extension PeriodExperimentalParticipants 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.
Receives: Drug: Upadacitinib
Study 2, Period B: Group 2 Open-Label Extension PeriodExperimentalParticipants that were randomized to receive placebo in Period A Group 2, will receive upadacitinib 15 mg once daily for 112 weeks in Period B.
Receives: Drug: Upadacitinib
(Optional) Study 3: Open Label UpadacitinibExperimentalParticipants will receive upadacitinib 15 mg once daily for 112 weeks.
Receives: Drug: Upadacitinib; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy
(Optional) Study 3: Open Label Upadacitinib + NB-UVBExperimentalParticipants will receive 15 mg upadacitinib once daily for 112 weeks and Narrow-band ultraviolet B (NB-UVB) for up to 28 weeks.
Receives: Drug: Upadacitinib; Other: NB-UVB (narrow-band ultraviolet B) Phototherapy
Study 4: Upadacitinib 15 mgExperimentalEligible participants will be re-randomized to receive upadacitinib 15 mg once daily for 56 weeks.
Receives: Drug: Upadacitinib
Study 4: Upadacitinib 30 mgExperimentalEligible participants will be re-randomized to receive upadacitinib 30 mg once daily for 56 weeks.
Receives: Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.

    Measured: Week 48

  2. Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.

    Measured: Week 48

  3. Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.

    Measured: Study 4 Week 28

  4. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately Week 175

Secondary outcomes (11)

  1. Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.

    Measured: Week 48

  2. Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.

    Measured: Week 24

  3. Percent Change from Baseline in F-VASI

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.

    Measured: Week 24

  4. Percent Change from Baseline in T-VASI

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.

    Measured: Week 48

  5. Percentage of Participants Achieving F-VASI 90 (≥ 90% Improvement in F-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.

    Measured: Week 48

  6. Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline)

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.

    Measured: Week 48

  7. Percentage of Participants Achieving 3D Imaging Facial Vitiligo 40 (≥ 40% Reduction in Facial Vitiligo Area Measured by 3D Digital Imaging from Baseline) (Study 1 Only)

    3D imaging will be used to objectively quantify the facial vitiligo area.

    Measured: Week 48

  8. Percentage of Participants Achieving No Increase from Baseline in T-VASI Among Participants with Actively Progressing Vitiligo at Baseline

    The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area [BSA]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100.

    Measured: Up to Approximately Week 12

  9. EU/EMA Only: Percentage of Participants Achieving a Physician's Global Impression of Change - Vitiligo (PhGIC-V) of "Much better (1)"

    The physician rates the overall change in the patients vitiligo by comparing the severity of vitiligo right now with the severity of vitiligo since the subject started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse."

    Measured: Week 48

  10. EU/EMA Only: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)"

    The VNS is a single-item, validated questionnaire used in clinical trials to assess the noticeability of vitiligo lesions following therapy. The item is scored on a 5-point scale: 1 = more noticeable; 2 = as noticeable; 3 = slightly less noticeable; 4 = a lot less noticeable; and 5 = no longer noticeable. A score of 4 or 5 represents treatment success

    Measured: Week 48

  11. EU/EMA Only: Percentage of Participants Achieving a Patient's Global Impression of Change-Vitiligo (PaGIC-V) of "Much better (1)"

    The PaGIC-V asks participants to rate the overall change in their vitiligo by comparing the severity of their vitiligo right now with the severity of their vitiligo since they started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse."

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start19 Dec 2023
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118411
Sponsor's protocol ID
M19-044
Other IDs
2023-506195-27-00, 2023
Acronym
Viti-Up
Status last verified
Jun 2026
First submitted
1 Nov 2023
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Passeron T, Prajapati VH, Sivamani RK, Ezzedine K, van Geel N, Hamzavi I, Pandya AG, Rosmarin D, Xiang L, Suzuki T, Desai S, Rashighi M, Suravaram S, Fish I, Hu X, Wu X, Wang M, Yu Y, Soliman AM, Camp HS, Teixeira HD, Patterson S, Schlosser BJ, Seneschal J. Efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (Viti-Up): results of two phase 3 randomised controlled studies. Lancet. 2026 Aug 15;408(10555):636-648. doi: 10.1016/S0140-6736(26)00896-2.

    PubMed 42594914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and NB-UVB (narrow-band ultraviolet B) Phototherapy in people with Vitiligo, run by AbbVie at 148 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, China, Germany, Poland, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) (time frame: Week 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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