Vitiligo
Conditions
Keywords
Vitiligo, Non-Segmented Vitiligo, Viti-Up, Upadacitinib
Brief summary
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.
Interventions
DRUGUpadacitinib
Oral Tablets
DRUGPlacebo
Oral Tablets
OTHERNB-UVB (narrow-band ultraviolet B) Phototherapy
NB-UVB phototherapy is a commonly used treatment modality in participants with vitiligo and can be administered in an office setting or at home 2 times per week
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Segmental or localized vitiligo. * History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo. * \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Total Vitiligo Area Scoring Index (T-VASI) 50 (≥ 50% Improvement in T-VASI From Baseline) | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. |
| Percentage of Participants Achieving Facial-Vitiligo Area Scoring Index (F-VASI) 75 (≥ 75% Improvement in F-VASI From Baseline) | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. |
| Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline) | Study 4 Week 28 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. |
| Number of Participants with Adverse Events (AEs) | Up to Approximately Week 175 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving F-VASI 50 (≥ 50% Improvement in F-VASI From Baseline) | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. |
| Percentage of Participants Achieving F-VASI 75 (≥ 75% Improvement in F-VASI From Baseline) | Week 24 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. |
| Percent Change from Baseline in F-VASI | Week 24 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. |
| Percent Change from Baseline in T-VASI | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. |
| Percentage of Participants Achieving F-VASI 90 (≥ 90% Improvement in F-VASI From Baseline) | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. |
| Percentage of Participants Achieving T-VASI 75 (≥ 75% Improvement in T-VASI From Baseline) | Week 48 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. |
| 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) | Week 48 | 3D imaging will be used to objectively quantify the facial vitiligo area. |
| Percentage of Participants Achieving No Increase from Baseline in T-VASI Among Participants with Actively Progressing Vitiligo at Baseline | Up to Approximately Week 12 | The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100. |
| EU/EMA Only: Percentage of Participants Achieving a Physician's Global Impression of Change - Vitiligo (PhGIC-V) of "Much better (1)" | Week 48 | The physician rates the overall change in the patients vitiligo by comparing the severity of vitiligo right now with the severity of vitiligo since the subject started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse." |
| EU/EMA Only: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) score of "A lot less noticeable (4)" or "No longer noticeable (5)" | Week 48 | The VNS is a single-item, validated questionnaire used in clinical trials to assess the noticeability of vitiligo lesions following therapy. The item is scored on a 5-point scale: 1 = more noticeable; 2 = as noticeable; 3 = slightly less noticeable; 4 = a lot less noticeable; and 5 = no longer noticeable. A score of 4 or 5 represents treatment success |
| EU/EMA Only: Percentage of Participants Achieving a Patient's Global Impression of Change-Vitiligo (PaGIC-V) of "Much better (1)" | Week 48 | The PaGIC-V asks participants to rate the overall change in their vitiligo by comparing the severity of their vitiligo right now with the severity of their vitiligo since they started the study treatment. Responses range from 1 = "Much better" to 5 = "Much worse." |
Countries
Argentina, Belgium, Bulgaria, Canada, China, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, Slovakia, South Korea, Spain, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed