NCT07431177 - A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo | Crick

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

210

Conditions

Non-segmental Vitiligo

Interventions

GIA632DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (10)

Cahaba Derm and skin hlth ctr 27

Birmingham, Alabama, United States

RECRUITING

Clinical Trials Research Institute

Thousand Oaks, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 24

Secondary Outcomes

Achievement of ≥75% improvement from baseline in the F-VASI (F-VASI75)

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.

Time frame: Baseline, Week 24

Percentage change from baseline in Total body Vitiligo Area Scoring Index (T-VASI) score.

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.

Time frame: Baseline, Week 24

Achievement of ≥50% improvement from baseline in T-VASI (T-VASI50)

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.

Time frame: Baseline, Week 24

Achievement of F-VASI50, F-VASI75, and FVASI90

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.

Central Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111