A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
A legfontosabb adatok
- Fázis
- 3. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 6 és 11 év között vagy?
Forrás: NCT07896434: ki vehet részt
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- AbbVie
- Azonosító
- NCT07896434EU 2025-524537-40-00
- A regiszteradat frissítve
- 2026. október 27.
- Eredeti leírás
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old.A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Pediatric Subjects 6 to <12 Years Old With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old.
This study will have two periods: Period A and Period B. 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 2 chance that participants will receive placebo. Participants who complete Period A will continue into Period B and remain on blinded treatment.
In Studies 1 and 2: Period A, participants will receive oral tablets (or oral solution) of upadacitinib or placebo once a day for 48 weeks. In Period B,participants who complete Period A will continue into Period B and remain on blinded treatment for 112 weeks. Participants will be followed up for 30 days. This study will enroll approximately 154 pediatric participants at 110 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). 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: Pediatric participants 6 to < 12 years of age at Screening and Baseline who have a documented clinical diagnosis of Non-Segmental Vitiligo (NSV); Must satisfy at least 1 of the following criteria at Screening and Baseline:; >= 0.5 Facial Vitiligo Area Scoring Index (F-VASI) and 5 <= Total Vitiligo Area Scoring Index (T-VASI) < 50 AND have failed to adequately respond to at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for NSV or; >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have active NSV or; >= 0.5 F-VASI and 10 <=T-VASI < 50; Must have no segmental or localized vitiligo; Must have no history of active skin disease other than NSV that could interfere with the assessment of NSV; Must not have > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).
Kizáró feltételek: History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline; History of active skin disease other than NSV that could interfere with the assessment of NSV; Screening laboratory values that meet the following criteria at the most recent testing prior to the first dose of study treatment:; Serum AST > 2 × ULN; Serum ALT > 2 × ULN; Estimated glomerular filtration rate (eGFR) by modified Schwartz equation < 60 mL/min/1.73 m2 Total WBC count < 3,000/μL; ANC < 1,500/μL; Platelet count < 100,000/μL; ALC < 800/μL; Hemoglobin < 10 g/dL; Participant has segmental or localized vitiligo; Participant has > 33% leukotrichia in areas of NSV on the face or > 33% leukotrichia in areas of NSV on the total body (including the face).