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

September 7, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1425DKG
        • Recruiting
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1119ACN
        • Recruiting
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Novartis Investigative Site
  • 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
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Recruiting
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Recruiting
        • Novartis Investigative Site
    • 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
      • Beijing, China, 100050
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33075
        • Recruiting
        • Novartis Investigative Site
      • Brest, France, 29609
        • Recruiting
        • Novartis Investigative Site
      • Créteil, France, 94010
        • Recruiting
        • Novartis Investigative Site
      • Nice, France, 06202
        • Recruiting
        • Novartis Investigative Site
      • Reims, France, 51100
        • Recruiting
        • Novartis Investigative Site
      • Rouen, France, 76031
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31400
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Bad Bentheim, Germany, 48455
        • Recruiting
        • Novartis Investigative Site
      • Bielefeld, Germany, 33647
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20354
        • Recruiting
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Recruiting
        • Novartis Investigative Site
      • Lübeck, Germany, 23538
        • Recruiting
        • Novartis Investigative Site
      • Münster, Germany, 48149
        • Recruiting
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Novartis Investigative Site
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Recruiting
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560074
        • Recruiting
        • Novartis Investigative Site
      • Belagavi, Karnataka, India, 590010
        • Recruiting
        • Novartis Investigative Site
      • Mysore, Karnataka, India, 570001
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Nashik, Maharashtra, India, 422101
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • AN
      • Ancona, AN, Italy, 60020
        • Recruiting
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44124
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Niigata, Japan, 9518520
        • Recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4678602
        • Recruiting
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 4578510
        • Recruiting
        • Novartis Investigative Site
    • Chiba
      • Urayasu, Chiba, Japan, 2790021
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Shinjuku Ku, Tokyo, Japan, 1600023
        • Recruiting
        • Novartis Investigative Site
    • Yamanashi
      • Kofu, Yamanashi, Japan, 4008506
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Novartis Investigative Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Recruiting
        • Novartis Investigative Site
      • Pontevedra, Spain, 36003
        • Recruiting
        • Novartis Investigative Site
      • Seville, Spain, 41009
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • 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
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology
        • Principal Investigator:
          • Vivian Laquer
        • Contact:
      • San Diego, California, United States, 92103
        • Recruiting
        • MedDerm Associates
        • Principal Investigator:
          • Michelle Pelle
        • Contact:
      • Thousand Oaks, California, United States, 91320
        • Recruiting
        • Clinical Trials Research Institute
        • Principal Investigator:
          • Navid Ezra
        • Contact:
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Encore Medical Research
        • Principal Investigator:
          • Jerome Obed
        • Contact:
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Principal Investigator:
          • Ashley Wentworth
        • Contact:
      • 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
        • Principal Investigator:
          • Wanda M Boote
        • Contact:
    • 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:
    • Oregon
      • Portland, Oregon, United States, 97223
        • Recruiting
        • Oregon Medical Research Center
        • Principal Investigator:
          • Benjamin D Ehst
        • Contact:
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research Tennessee LCC
        • Principal Investigator:
          • Christina Feser
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire Dermatology Associates
        • Principal Investigator:
          • Craig F Teller
        • Contact:
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGIA632B12201
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522301-37-00 (Other Identifier: EU CTIS)

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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