臨床研究等提出・公開システム

A Phase 3, Randomized, Placebo-Controlled, Double-BlindStudy to Evaluate the Efficacy, Safety, and Tolerability ofUpadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo

Otani Tetsuya

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Patients and HCP Contact

AbbVie GK

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

Feb. 27, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Documented clinical diagnosis of non-segmented vitiligo(NSV).
-At Screening and Baseline Visits, participants must satisfyat least 1 of the following criteria:
-- >= 0.5 F-VASI and 5 <= T-VASI < 50 AND have failedat 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 signof actively progressing vitiligo; or
-- >= 0.5 F-VASI and 10 <= T-VASI < 50.

-Segmental or localized vitiligo.
-History of active skin disease other than vitiligo that couldinterfere with the assessment of vitiligo.
- >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (includingthe face).

Both

Non-Segmental Vitiligo

Upadacitinib or Placebo

Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI)50 ( 50% Improvement in T-VASI From Baseline) at week 48.
Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI)75 ( 75% Improvement in F-VASI From Baseline) at week 48.

Percentage of Participants Achieving F-VASI 50 ( 50% Improvement in F-VASIFrom Baseline) at week48.
Percent Change from Baseline in F-VASI at week24.
Percentage of Participants Achieving T-VASI 75 ( 75% Improvement in T-VASIFrom Baseline) at week 48.
Percentage of Participants Achieving F-VASI 75 ( 75% Improvement in F-VASIFrom Baseline) at week 24.
Percentage of Participants Achieving F-VASI 90 ( 90% Improvement in F-VASIFrom Baseline) at week 48.
Percentage of Participants Achieving Patient Global Impression of Severity of
Vitiligo Sun Sensitivity Score of "Not Sensitive at All (0)" or "Mildly Sensitive (1)"For Participants with a Score of "Moderately Sensitive (2)" or Higher at Baseline at week 48.
Percent Change From Baseline in T-VASI at week 48.
Percentage of Participants Achieving Patient Global Impression of Noticeability(PGIN) Score of "Not Noticeable at All (0)" or "A Little Noticeable (1)" For
Participants with a Score of "Moderately Noticeable (2)" or "Very Noticeable (3)"at Baseline at week 48.
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) at week 48.

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinicaltrials/clinical-trials-data-and-information-sharing.html

Argentina/Belgium/Bulgaria/Canada/Chile/China/France/Germany/Hungary/Israel/Italy/Netherlands/Poland/Portugal/Puerto Rico/Slovakia/South Africa/South Korea/Spain/United States of America