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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 258 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Woodland International Research Group /ID# 275747
RECRUITING
Little Rock
California
Collaborative Neuroscience Research - Garden Grove /ID# 273005
RECRUITING
Garden Grove
California Clinical Trials Medical Group - Parexel /ID# 275751
RECRUITING
Glendale
Maryland
Cbh Health - Gaithersburg /ID# 272932
RECRUITING
Gaithersburg
New Jersey
Cenexel Hassman Research Institute (Hri) /ID# 276128
RECRUITING
Marlton
Texas
Community Clinical Research - Austin - Cross Park Drive /ID# 272977
RECRUITING
Austin
Pillar Clinical Research - Richardson /ID# 275715
RECRUITING
Richardson
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2028-02
Participants
Target number of participants: 258
Treatments
Experimental: Emraclidine Part A
Participants will be assigned to received one of multiple ascending doses of oral emraclidine for 14 or up to 21 days, followed by a 30-day safety follow-up period.
Experimental: Placebo-Part A
Participants will be assigned to received one of multiple ascending doses of oral placebo for 14 or up to 21 days, followed by a 30-day safety follow-up period.
Experimental: Emraclidine-Part B
Participants will receive oral emraclidine for 42 days followed by a 30-day safety follow-up period.
Experimental: Placebo-Part B
Participants will receive placebo for 42 days followed by a 30-day safety follow-up period.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov