BI 425809 Proof of Concept in Schizophrenia

A phase II randomized, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 425809 once daily over 12 week treatment period in patients with Schizophrenia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223908

Enrollment

504

Registered

2018-05-22

Start date

2018-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material : contr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory	—

Secondary

Measure	Time frame
exploratory	—

Countries

Asia except Japan, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026