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NCT Number: NCT07431177

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

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.

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Key information

Conditions

Non-Segmental Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Vitiligo

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIA632

Drug

GIA632 will be administered during the 48-week core period.

Placebo

Drug

Placebo will be administered during the 48-week core period.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: VITESS

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 24, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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