A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
VITESS
A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase IIb Study to Assess the Efficacy and Safety of GIA632 in Adult Participants With Non-segmental Vitiligo Followed by an Extension Period
1 other identifier
interventional
210
4 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
February 24, 2026
CompletedStudy Start
First participant enrolled
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2030
May 19, 2026
May 1, 2026
2.2 years
February 18, 2026
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
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.
Baseline, Week 24
Secondary Outcomes (6)
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)
Baseline, Week 24
Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.
Baseline, Week 24
Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)
Baseline, Week 24
Achievement of F-VASI50, F-VASI75, and FVASI90
Baseline, Week 12, Week 24, Week 36, and Week 48
Achievement of T-VASI50, T-VASI75, and TVASI90
Baseline, Week 12, Week 24, Week 36, and Week 48.
- +1 more secondary outcomes
Study Arms (5)
GIA632 Arm 1
EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 2
EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 3
EXPERIMENTALGIA632 will be administered during the 48-week core period.
GIA632 Arm 4
EXPERIMENTALGIA632 will be administered during the 48-week core period.
Placebo
PLACEBO COMPARATORPlacebo will be administered during the 48-week core period.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, 35244, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Miami Derm and Laser Institute
Miami, Florida, 33173, United States
Global Clinical Professionals
St. Petersburg, Florida, 33714, United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Revival Research Institute
Troy, Michigan, 48084, United States
Skin Specialists PC
Omaha, Nebraska, 68144, United States
Las Vegas Dermatology
Las Vegas, Nevada, 89144, United States
Equity Medical
The Bronx, New York, 10455, United States
International Clinical Research Tennessee LCC
Murfreesboro, Tennessee, 37130, United States
Center for Clinical Studies
Houston, Texas, 77030, United States
Austin Inst for Clinical Research
Pflugerville, Texas, 78660, United States
ACRC Trials
Plano, Texas, 75024, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Novartis Investigative Site
Sydney, New South Wales, 2010, Australia
Novartis Investigative Site
Waitara, New South Wales, 2077, Australia
Novartis Investigative Site
Melbourne, Victoria, 3000, Australia
Novartis Investigative Site
Mississauga, Ontario, L4Y 4C5, Canada
Novartis Investigative Site
Newmarket, Ontario, L3Y 5G8, Canada
Novartis Investigative Site
Toronto, Ontario, M3H 5Y8, Canada
Novartis Investigative Site
Québec, Quebec, G1V 4X7, Canada
Novartis Investigative Site
Urayasu, Chiba, 279-0021, Japan
Novartis Investigative Site
Kofu, Yamanashi, 400-8506, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2026
First Posted
February 24, 2026
Study Start
March 9, 2026
Primary Completion (Estimated)
June 6, 2028
Study Completion (Estimated)
January 28, 2030
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.