A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Purpose
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.
Condition
- Non-segmental Vitiligo
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts 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/exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GIA632 Arm 1 |
GIA632 will be administered during the 48-week core period. |
|
|
Experimental GIA632 Arm 2 |
GIA632 will be administered during the 48-week core period. |
|
|
Experimental GIA632 Arm 3 |
GIA632 will be administered during the 48-week core period. |
|
|
Experimental GIA632 Arm 4 |
GIA632 will be administered during the 48-week core period. |
|
|
Placebo Comparator Placebo |
Placebo will be administered during the 48-week core period. |
|
Recruiting Locations
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama 35244
Birmingham, Alabama 35244
Clinical Trials Research Institute
Thousand Oaks, California 91320
Thousand Oaks, California 91320
Miami Derm and Laser Institute
Miami, Florida 33173
Miami, Florida 33173
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
Hamzavi Dermatology
Fort Gratiot, Michigan 48059
Fort Gratiot, Michigan 48059
Skin Specialists PC
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Las Vegas Dermatology
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Austin Inst for Clinical Research
Pflugerville, Texas 78660
Pflugerville, Texas 78660
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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.