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

Official title

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

Overview

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.

Interventions

• Drug Emraclidine
  Oral Tablets
• Drug Placebo
  Oral Tablets

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 7 centers

• 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

Identifiers

NCT: NCT07145918 · M25-522

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗