A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo.

Phase 3

Active, not recruiting

Conditions: non-segmental vitiligo

Registration Number: 2023-506195-27-00

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: The primary objective of Study 1 and Study 2 is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with NSV who are eligible for systemic therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 239

Inclusion Criteria

Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures.

Adult and adolescent individuals, ≥ 12 years of age at Screening.

Body weight must be ≥ 30 kg at Baseline Visit for subjects who are ≥ 12 and < 18 years of age.

Documented clinical diagnosis of NSV.

At Screening and Baseline Visits, subject 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.

Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the Screening assessments and medical history.

Pregnancy testing in female subjects of childbearing potential • Females of childbearing potential must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). • Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result (unless prohibited by local requirements). • Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test

Exclusion Criteria

Subject has segmental or localized vitiligo.

Subject has been treated with any permanent skin bleaching agents.

Subject has a history of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.

Subject must not have > 33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face).

Subject has current or past history of any of the following infections: •Two or more episodes of herpes zoster, or one or more episodes or disseminated herpes zoster; • One or more episodes of disseminated herpes simplex (including eczema herpeticum); • Human immunodeficiency virus infection defined as confirmed positive anti-HIV antibody test; • Active TB or meet TB exclusionary parameters (specific requirements for TB testing will be provided in the Operations Manual [Appendix F]);

Subject has evidence of: • HBV • HCV

There must be no reason the investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.

Subject must not have a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

The investigator believes that the subject is an unsuitable candidate to participate in the study, receive study drug, or would be placed at risk by participating in the study.

Subject has been treated with any systemic JAK inhibitor.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48		Achievement of T-VASI 50 (≥ 50% reduction in T-VASI from Baseline) at Week 48
Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48		Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 48

Secondary Outcome Measures

Name	Time	Method
Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;		Achievement of F-VASI 50 (≥ 50% reduction in F-VASI from Baseline) at Week 48;
Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;		Achievement of F-VASI 75 (≥ 75% reduction in F-VASI from Baseline) at Week 24;
Percent change from Baseline in F-VASI at Week 24;		Percent change from Baseline in F-VASI at Week 24;
Percent change from Baseline in T-VASI at Week 48;		Percent change from Baseline in T-VASI at Week 48;
Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;		Achievement of F-VASI 90 (≥ 90% reduction in F-VASI from Baseline) at Week 48;
Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;		Achievement of VNS score of "A lot less noticeable (4)" or "No longer noticeable (5)" at Week 48;
Achievement of PaGIC-V of "Much better (1)" at Week 48.		Achievement of PaGIC-V of "Much better (1)" at Week 48.
Achievement of PhGIC-V of "Much better (1)" at Week 48;		Achievement of PhGIC-V of "Much better (1)" at Week 48;

Trial Locations

Locations (58): Derma-B Kft.
🇭🇺
Debrecen, Hungary
Semmelweis University
🇭🇺
Budapest VIII, Hungary
Medical Center Kordis OOD
🇧🇬
Pleven, Bulgaria
Military Medical Academy
🇧🇬
Sofiya, Bulgaria
ASMC IPSMC Skin And Venereal Diseases
🇧🇬
Sofiya, Bulgaria
Diagnostic Consultation Center XX-Sofia EOOD
🇧🇬
Sofia, Bulgaria
Dkc Fokus-5 Lzip OOD
🇧🇬
Sofiya, Bulgaria
Grand Hopital De Charleroi
🇧🇪
Charleroi, Belgium
CHU De Liege
🇧🇪
Liege, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪
Sint-Lambrechts-Woluwe, Belgium
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Derma-B Kft.
🇭🇺Debrecen, Hungary
Emese Heredi
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