BridgeMD
A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo.
EU CTIS ID: 2023-506195-27-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Chile
- China
- Puerto Rico
- Canada
- Argentina
- South Africa
- Japan
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Chile; China; Puerto Rico; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.