A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy in Trial Participants With Vitiligo

Официальное название

A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial of Multiple Subcutaneous Injections of GR2301 in Combination With Phototherapy to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy in Trial Participants With Vitiligo

Обзор

This is a randomized, double-blind, placebo-controlled Phase Ib/II clinical trial of multiple subcutaneous injections of GR2301 in combination with phototherapy to evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy in trial participants with vitiligo. The trial will be conducted in two stages: a dose-escalation stage (Phase Ib) and an expansion cohort stage (Phase II).

Вмешательства

• Биопрепарат GR2301 injection
  IL15 monoclonal antibody
• Биопрепарат Placebo
  Placebo

Первичные конечные точки

• Adverse events (AEs)( Phase Ib） [Срок оценки: up to 52weeks]
• Proportion of subjects achieving F-VASI 75(Phase II) [Срок оценки: Week 24]

Вторичные конечные точки (8)

• Change from baseline and percent change from baseline in F-VASI/T-VASI [Срок оценки: Week 24、36、48、52]
• Proportion of subjects achieving F/T-VASI 35, 50, and 75 [Срок оценки: Week 24、36、48、52]
• Percent change from baseline in facial body surface area (F-BSA) and total body surface area (T-BSA) affected by vitiligo [Срок оценки: Week 24、36、48、52]
• Proportion of subjects achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA) [Срок оценки: Week 24、36、48、52]
• Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) [Срок оценки: Week 24、36、48、52]
• Proportion of subjects achieving a score of 1 or 2 on the Facial Patient Global Impression of Change for Vitiligo (F-PaGIC-V) and the Total Patient Global Impression of Change for Vitiligo (T-PaGIC-V) [Срок оценки: Week 24、36、48、52]
• Incidence of Anti-Drug Antibodys (ADAs) [Срок оценки: up to 52weeks]
• drug concentration [Срок оценки: up to 52 weeks]

Критерии участия

Main Inclusion Criteria:

• Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of non-segmental vitiligo for at least 3 months at screening visit; facial affected BSA ≥0.5% and total body affected BSA ≥3% at screening visit and baseline visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit.
• Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and provide signed written informed consent by the trial participant or their legally authorized representative.

Main Exclusion Criteria:

• Vitiligo-related medical conditions and other dermatologic diseases/conditions.
• Prior permanent tattooing or grafting within the vitiligo lesions.
• Have absolute contraindications to phototherapy; or have relative contraindications to phototherapy (as comprehensively judged by the investigator).
• Are unwilling or unable to comply with the permitted and prohibited concomitant medications/treatment specifications of this trial, and cannot meet the protocol-required washout period for medications/treatments prior to randomization.
• Have a serious underlying disease that, in the investigator's opinion, may pose a safety risk to the trial participant if enrolled in the clinical trial.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07647237 · GR2301-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗