Non-segmental Vitiligo
Conditions
Keywords
Phase 2b, interventional, vitiligo, efficacy, safety, dose ranging
Brief summary
The main purpose of this multicenter, randomized, double-blind, placebo-controlled Phase 2b study is to investigate the safety and efficacy of GIA632 in participants with NSV and to identify the optimal dose to be promoted into the confirmatory Phase 3 program.
Detailed description
This trial in adult participants ≥ 18 years with non-segmental vitiligo (NSV) consists of a randomized, double-blind, placebo-controlled period to establish and characterize the dose-response relationship of GIA632 and estimate the targeted doses treatment effect compared with placebo, followed by the assessment of longer term safety and efficacy in extension period.
Interventions
DRUGGIA632
GIA632 will be administered during the 48-week core period.
DRUGPlacebo
Placebo will be administered during the 48-week core period.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent must be obtained prior to participation in the study * Male or female as assigned at birth ≥ 18 years of age at the time of screening * Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator * Non-segmental vitiligo, as assessed at screening, as * ≥ 0.5% Body Surface Area (BSA) on the face and F-VASI score ≥ 0.5 * ≥ 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60
Exclusion criteria
* Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires * Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations \[such as piebaldism, Waardenburg, etc.\], chemical- or druginduced leukoderma, etc.) * Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors * Individual who previously attempted or completed depigmentation therapy for NSV * Use of prohibited medication \& treatments. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. | Baseline, Week 24 | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75) | Baseline, Week 24 | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. |
| Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score. | Baseline, Week 24 | T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. |
| Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50) | Baseline, Week 24 | T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. |
| Achievement of F-VASI50, F-VASI75, and FVASI90 | Baseline, Week 12, Week 24, Week 36, and Week 48 | The F-VASI assesses the percentage of facial area affected by vitiligo. It ranges from 0 to 3.5, with 0 representing no vitiligo on the face and 3.5 representing complete depigmentation of the assessed facial areas. F-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the facial vitiligo area scoring index (F-VASI), respectively. |
| Achievement of T-VASI50, T-VASI75, and TVASI90 | Baseline, Week 12, Week 24, Week 36, and Week 48. | T-VASI is the sum for all body sites of the product of percentage of BSA affected multiplied by the degree of depigmentation. T-VASI includes the face (in the head/neck calculation), and therefore can include the calculated F-VASI score. T-VASI ranges from 0 to 100, with 0 representing no vitiligo and 100 representing complete depigmentation of the entire body. T-VASI50, 75, 90: at least 50%, 75%, 90% improvement from Baseline in the total vitiligo area scoring index (T-VASI), respectively. |
| Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5 | Week 12, Week 24, Week 36, and at Week 48. | The VNS is a patient-reported outcome (PRO) measure of treatment response, which has been shown to have face validity. This involved an online survey, to identify which aspects of treatment response are most important to participants. A scale with five response options (both words and numbers) is the best available scale to use when assessing treatment response (whereas giving a binary 'yes'/'no' response was more difficult); and a score of 4 or 5 on the scale represents a successful treatment response. |
Countries
Argentina, Australia, Canada, China, France, Germany, India, Italy, Japan, Netherlands, Spain, United States
Contacts
CONTACTNovartis Pharmaceuticals
Outcome results
None listed