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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Percentage change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) score. [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Cahaba Derm and skin hlth ctr 27 — Birmingham
• First OC Dermatology — Fountain Valley
• MedDerm Associates — San Diego
• Clinical Trials Research Institute — Thousand Oaks
• Encore Medical Research — Hollywood
• Mayo Clinic Jacksonville — Jacksonville
• Miami Derm and Laser Institute — Miami
• Global Clinical Professionals — St. Petersburg
• … и ещё 13 центров

Канада · 6 центров

• Novartis Investigative Site — Calgary
• Novartis Investigative Site — Winnipeg
• Novartis Investigative Site — Mississauga
• Novartis Investigative Site — Newmarket
• Novartis Investigative Site — Toronto
• Novartis Investigative Site — Québec

Индия · 5 центров

• Novartis Investigative Site — Ahmedabad
• Novartis Investigative Site — Bangalore
• Novartis Investigative Site — Belagavi
• Novartis Investigative Site — Mysore
• Novartis Investigative Site — Nashik

Германия · 4 центра

• Novartis Investigative Site — Munich
• Novartis Investigative Site — Bad Bentheim
• Novartis Investigative Site — Hamburg
• Novartis Investigative Site — Münster

Австралия · 3 центра

• Novartis Investigative Site — Sydney
• Novartis Investigative Site — Waitara
• Novartis Investigative Site — Melbourne

Франция · 3 центра

• Novartis Investigative Site — Brest
• Novartis Investigative Site — Rouen
• Novartis Investigative Site — Toulouse

Япония · 3 центра

• Novartis Investigative Site — Urayasu
• Novartis Investigative Site — Kofu
• Novartis Investigative Site — Niigata

Китай · 2 центра

• Novartis Investigative Site — Пекин
• Novartis Investigative Site — Шанхай

Италия · 2 центра

• Novartis Investigative Site — Ancona
• Novartis Investigative Site — Rozzano

Нидерланды · 2 центра

• Novartis Investigative Site — Amsterdam
• Novartis Investigative Site — Rotterdam

Испания · 1 центр

• Novartis Investigative Site — Barcelona

Идентификаторы

NCT: NCT07431177 · CGIA632B12201 · 2025-522301-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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