A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia

Официальное название

An Adaptive Two-part Randomized, Double Blind, Placebo-controlled Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Emraclidine in Participants With Schizophrenia

Обзор

Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 268 participants will be enrolled across roughly 32 sites in the United States. Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат Emraclidine
  Oral Tablets
• Препарат Placebo
  Oral Tablets

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 74 days]
• Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine [Срок оценки: Up to approximately 24 days]
• Part A Only-Time to Cmax (Tmax) of Emraclidine [Срок оценки: Up to approximately 24 days]
• Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine [Срок оценки: Up to approximately 24 days]
• Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine [Срок оценки: Up to approximately 24 days]
• Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine [Срок оценки: Up to approximately 21 days]
• Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine [Срок оценки: Up to approximately 21 days]
• Part A Only- Minimum plasma concentration (Cmin) of Emraclidine [Срок оценки: Up to approximately 21 days]
• Part A Only-Average plasma concentration (Cavg) of Emraclidine [Срок оценки: Up to approximately 21 days]
• Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine [Срок оценки: Up to approximately 21 days]

Вторичные конечные точки (5)

• Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score [Срок оценки: Up to approximately Week 6]
• Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score [Срок оценки: Up to approximately 74 days]
• Part B Only-Change from Baseline in in Clinical Global Impression of Severity (CGIS) score [Срок оценки: Up to approximately 53 days]
• Part B Only-Number of Participants achieving ≥ 30% improvement in PANSS total score [Срок оценки: Up to approximately week 6]
• Part B Only-Number of Participants achieving remission (PANSS total score ≤ 60) [Срок оценки: Up to approximately week 6]

Критерии участия

Критерии включения

• BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight > 50 kg (110 lbs).
• (Part A only): Positive and Negative Syndrome Scale (PANSS) total score < 80 at Screening and at Baseline
• (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening
• (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline
• (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline
• (Part B only): Participant must have a Clinical Global Impression of Severity (CGIS) score ≥ 4 (at least moderately ill) at Screening and Baseline

Критерии исключения

• Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
• History of clozapine exposure.
• History of treatment resistance to schizophrenia medications, defined as failure to respond to 2 or more adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the last 12 months

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Woodland International Research Group /ID# 275747 — Little Rock
• Collaborative Neuroscience Research - Garden Grove /ID# 273005 — Garden Grove
• California Clinical Trials Medical Group - Parexel /ID# 275751 — Glendale
• Cbh Health - Gaithersburg /ID# 272932 — Gaithersburg
• Cenexel Hassman Research Institute (Hri) /ID# 276128 — Marlton
• Community Clinical Research - Austin - Cross Park Drive /ID# 272977 — Austin
• Pillar Clinical Research - Richardson /ID# 275715 — Richardson

Идентификаторы

NCT: NCT07145918 · M25-522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗