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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Non-segmental Vitiligo

Treatments: Drug: Placebo; Drug: GIA632

Study type: Interventional

Funder types: Industry

Identifiers

NCT07431177

CGIA632B12201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 5 patient groups, including a placebo group

GIA632 Arm 1

Experimental group

Description:

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

Treatment:

Drug: GIA632

GIA632 Arm 2

Experimental group

Description:

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

Treatment:

Drug: GIA632

GIA632 Arm 3

Experimental group

Description:

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

Treatment:

Drug: GIA632

GIA632 Arm 4

Experimental group

Description:

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

Treatment:

Drug: GIA632

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo