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

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Hol
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 és Worcester (Egyesült Államok)Mind a 46 helyszín megnézése
Fázis
3. fázis

Helyszínek itt: Egyesült Államok

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

A vizsgálat adatai

Ki végzi
AbbVie
Azonosító
NCT06118411EU 2023-506195-27-00
A regiszteradat frissítve
2026. június 9.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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).

ClinicalTrials.gov NCT06118411 · EU CTIS 2023-506195-27-00