A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Launched by ABBVIE · Nov 1, 2023
Trial Information
Current as of June 26, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a medication called upadacitinib for adults and adolescents with a skin condition known as non-segmental vitiligo (NSV). Vitiligo is a long-term condition where the immune system attacks the skin cells that give our skin its color, leading to lighter patches on the skin. In the trial, participants will take either upadacitinib or a placebo (a non-active pill) for the first 48 weeks, followed by 112 weeks of taking upadacitinib. The trial aims to see how well the treatment works, monitor any side effects, and assess changes in the condition.
To be eligible for this trial, participants must have a confirmed diagnosis of NSV and meet certain requirements regarding the severity of their condition. They should have tried at least one other treatment that did not work, or have signs that their vitiligo is getting worse. Throughout the study, participants will visit a clinic regularly for check-ups, blood tests, and to answer questions about their health. It's important to note that this trial may involve more visits and treatments compared to standard care for vitiligo.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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).
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Clarkston, Michigan, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Brandon, Florida, United States
Dawsonville, Georgia, United States
Stony Brook, New York, United States
Bellaire, Texas, United States
Encino, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Thousand Oaks, California, United States
Boca Raton, Florida, United States
Coral Gables, Florida, United States
Hollywood, Florida, United States
Hollywood, Florida, United States
Margate, Florida, United States
Margate, Florida, United States
Miami Lakes, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Dawsonville, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Auburn Hills, Michigan, United States
Canton, Michigan, United States
New Brighton, Minnesota, United States
Verona, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Sakai Shi, Osaka, Japan
Yamagata Shi, Yamagata, Japan
Kofu Shi, Yamanashi, Japan
Coral Gables, Florida, United States
Encino, California, United States
Caguas, , Puerto Rico
Shinjuku Ku, Tokyo, Japan
San Juan, , Puerto Rico
Phoenix, Arizona, United States
Encino, California, United States
Irvine, California, United States
Redwood City, California, United States
Sacramento, California, United States
Boca Raton, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Margate, Florida, United States
Weston, Florida, United States
Dawsonville, Georgia, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Auburn Hills, Michigan, United States
Bay City, Michigan, United States
Clarkston, Michigan, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Plano, Texas, United States
San Antonio, Texas, United States
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Buenos Aires, , Argentina
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Charleroi, Hainaut, Belgium
Gent, Oost Vlaanderen, Belgium
Liege, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Sofiya, , Bulgaria
Sofiya, , Bulgaria
Calgary, Alberta, Canada
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
Fredericton, New Brunswick, Canada
Hamilton, Ontario, Canada
Waterloo, Ontario, Canada
Québec, Quebec, Canada
Saint Jerome, Quebec, Canada
Beijing, Beijing, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Xi'an, Shaanxi, China
Xian, Shaanxi, China
Jinan, Shandong, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Tianjin, Tianjin, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Nice, Alpes Maritimes, France
Bordeaux, Gironde, France
Creteil, Paris, France
Lyon, Rhone, France
Toulouse, , France
Erlangen, Bayern, Germany
Blankenfelde Mahlow, Brandenburg, Germany
Bonn, Hessen, Germany
Frankfurt Am Main, Hessen, Germany
Bad Bentheim, Niedersachsen, Germany
Muenster, Nordrhein Westfalen, Germany
Mainz, Rheinland Pfalz, Germany
Halle, Sachsen Anhalt, Germany
Dresden, Sachsen, Germany
Berlin, , Germany
Munich, , Germany
Debrecen, , Hungary
Haifa, H Efa, Israel
Ramat Gan, Tel Aviv, Israel
Tel Aviv, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Haifa, , Israel
Rome, Roma, Italy
Brescia, , Italy
Nagoya Shi, Aichi, Japan
Suita Shi, Osaka, Japan
Bunkyo Ku, Tokyo, Japan
Daejeon, Daejeon Gwang Yeogsi, Korea, Republic Of
Bucheon Si, Gyeonggido, Korea, Republic Of
Suwon Si, Gyeonggido, Korea, Republic Of
Suwon, Gyeonggido, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Bergen Op Zoom, Noord Brabant, Netherlands
Breda, Noord Brabant, Netherlands
Amsterdam, Noord Holland, Netherlands
Osielsko, Kujawsko Pomorskie, Poland
Krakow, Malopolskie, Poland
Krakow, Malopolskie, Poland
Krakow, Malopolskie, Poland
Warsaw, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Katowice, Slaskie, Poland
Szczecin, Zachodniopomorskie, Poland
Coimbra, , Portugal
Leiria, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Bayamon, , Puerto Rico
Bratislava, Bratislavsky Kraj, Slovakia
Trnava, , Slovakia
Badalona, Barcelona, Spain
Getafe, Madrid, Spain
Pozuelo De Alarcon, Madrid, Spain
Granada, , Spain
Madrid, , Spain
Valencia, , Spain
Zaragoza, , Spain
Haifa, , Israel
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported