Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

Официальное название

A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)

Обзор

The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of schizophrenia

Вмешательства

• Препарат GXV813
  GXV813 administered orally.
• Препарат Placebo
  Placebo administered orally.

Первичные конечные точки

• Change from baseline in Positive and Negative Symptom Scale (PANSS) total score [Срок оценки: Baseline, Week 6]

Вторичные конечные точки (8)

• Number of participants with AEs [Срок оценки: Baseline to 6 weeks]
• Participant clinically significant response [Срок оценки: Baseline, week 6]
• Change from baseline in PANSS positive sub-score [Срок оценки: Baseline, week 6]
• Change from baseline in PANSS negative sub-score [Срок оценки: Baseline, week 6]
• Change from baseline in Marder negative factor score [Срок оценки: Baseline, week 6]
• Change from baseline in Clinical Global Impression- Severity (CGI-S) scale [Срок оценки: Baseline up to week 6]
• Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC) [Срок оценки: Up to 6 weeks]
• Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax) [Срок оценки: Up to 6 weeks]

Критерии участия

Критерии включения

• Participant is aged 18 to 65 years, inclusive, at screening
• Participant is capable of providing informed consent
• Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
• Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
• Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening

• The participant requires hospitalization for this acute exacerbation or relapse of symptoms
• If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
• Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:

i. Item 1 (P1; delusions)

ii. Item 2 (P2; conceptual disorganization)

iii. Item 3 (P3; hallucinatory behavior)

iv. Item 6 (P6; suspiciousness/persecution)

Критерии исключения

• Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
• History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
• Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
• Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Болгария · 9 центров

• Novartis Investigative Site — Sofia
• Novartis Investigative Site — Haskovo
• Novartis Investigative Site — Kazanlak
• Novartis Investigative Site — Lovech
• Novartis Investigative Site — Plovdiv
• Novartis Investigative Site — Sliven
• Novartis Investigative Site — Sofia
• Novartis Investigative Site — Veliko Tarnovo
• … и ещё 1 центр

США · 7 центров

• Pillar Clinical Research LLC — Bentonville
• CNRI Los Angeles LLC — Pico Rivera
• Segal Institute for Clinical Research — Miami
• CenExel iResearch — Decatur
• Uptown Research Institute LLC — Chicago
• Pillar Clinical Research LLC — Chicago
• Arch Clinical Trials LLC — St Louis

Идентификаторы

NCT: NCT07467993 · CGXV813B12201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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