A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo (VITESS)

May 25, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • Novartis Investigative Site
      • Waitara, New South Wales, Australia, 2077
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4Y 4C5
        • Recruiting
        • Novartis Investigative Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M3H 5Y8
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Québec, Quebec, Canada, G1V 4X7
        • Recruiting
        • Novartis Investigative Site
  • China
      • Shanghai, China, 200040
        • Recruiting
        • Novartis Investigative Site
  • Japan
    • Chiba
      • Urayasu, Chiba, Japan, 279-0021
        • Recruiting
        • Novartis Investigative Site
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-8506
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Derm and skin hlth ctr 27
        • Principal Investigator:
          • Vlada Groysman
        • Contact:
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • MedDerm Associates
        • Contact:
        • Principal Investigator:
          • Michelle Pelle
      • Thousand Oaks, California, United States, 91320
        • Recruiting
        • Clinical Trials Research Institute
        • Principal Investigator:
          • Navid Ezra
        • Contact:
    • Florida
      • Miami, Florida, United States, 33173
        • Recruiting
        • Miami Derm and Laser Institute
        • Principal Investigator:
          • Jill Waibel
        • Contact:
      • St. Petersburg, Florida, United States, 33714
        • Recruiting
        • Global Clinical Professionals
        • Contact:
        • Principal Investigator:
          • Wanda M Boote
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Dawes Fretzin Clinical Rea Group
        • Principal Investigator:
          • Kenneth Dawes
        • Contact:
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Recruiting
        • Hamzavi Dermatology
        • Principal Investigator:
          • Iltefat Hamzavi
        • Contact:
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute
        • Principal Investigator:
          • Ali Moiin
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists PC
        • Principal Investigator:
          • Joel Schlessinger
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Las Vegas Dermatology
        • Contact:
        • Principal Investigator:
          • Harry Lawrence Greenberg
    • New York
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical
        • Principal Investigator:
          • Michael Cameron
        • Contact:
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research Tennessee LCC
        • Principal Investigator:
          • Christina Feser
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Center for Clinical Studies
        • Principal Investigator:
          • Stephen K Tyring
        • Contact:
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Inst for Clinical Research
        • Principal Investigator:
          • Edward Lain
        • Contact:
      • Plano, Texas, United States, 75024
        • Recruiting
        • ACRC Trials
        • Contact:
        • Principal Investigator:
          • Seemal Rohit Desai
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Virginia Clinical Research
        • Principal Investigator:
          • David M Pariser
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GIA632 Arm 1
GIA632 will be administered during the 48-week core period.
Drug: GIA632
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 2
GIA632 will be administered during the 48-week core period.
Drug: GIA632
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 3
GIA632 will be administered during the 48-week core period.
Drug: GIA632
GIA632 will be administered during the 48-week core period.
Experimental: GIA632 Arm 4
GIA632 will be administered during the 48-week core period.
Drug: GIA632
GIA632 will be administered during the 48-week core period.
Placebo Comparator: Placebo
Placebo will be administered during the 48-week core period.
Drug: Placebo
Placebo will be administered during the 48-week core period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score.
Time Frame: 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.
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)
Time Frame: 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.
Baseline, Week 24
Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.
Time Frame: 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.
Baseline, Week 24
Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)
Time Frame: 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.
Baseline, Week 24
Achievement of F-VASI50, F-VASI75, and FVASI90
Time Frame: 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.
Baseline, Week 12, Week 24, Week 36, and Week 48
Achievement of T-VASI50, T-VASI75, and TVASI90
Time Frame: 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.
Baseline, Week 12, Week 24, Week 36, and Week 48.
Achievement of Vitiligo Noticeability Scale Score (VNS) of 4 or 5
Time Frame: 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.
Week 12, Week 24, Week 36, and at Week 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

June 6, 2028

Study Completion (Estimated)

January 28, 2030

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGIA632B12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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