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A Study to Test Long-term Safety of BI 425809 in People With Schizophrenia Who Took Part in a Previous CONNEX Study

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05211947
Collaborator
(none)
1,401
Enrollment
40
Locations
1
Arm
38.7
Anticipated Duration (Months)
35
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called BI 425809 in the long term.

Participants take BI 425809 as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.

Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.

The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 425809
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1401 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of BI 425809 Once Daily in Patients With Schizophrenia Who Have Completed Previous BI 425809 Phase III Trials (CONNEX-X)
Actual Study Start Date :
Mar 3, 2022
Anticipated Primary Completion Date :
May 3, 2025
Anticipated Study Completion Date :
May 24, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with cognitive impairment due to schizophrenia

Drug: BI 425809
BI 425809

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment emergent adverse events (TEAEs) [up to 1 year and 12 days]

Secondary Outcome Measures

  1. Change from baseline in Clinical Global Impressions - Severity (CGI-S) to end of treatment (EOT) [up to 1 year]

    The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S is rated ordinal from 1 to 7, with 1=normal (not at all ill) to 7=patient among the most extremely ill patients.

  2. Change from baseline in Haemoglobin (Hb) to EOT [up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 51 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Signed and dated written informed consent.

  • Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)).

  • Patients, who completed participation in the parent trial.

  • Women of childbearing potential must use highly effective methods of birth control.

  • Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Exclusion criteria:

  • Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase III trial.

  • Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.

  • Positive urine drug screen ≥ 3 times during the treatment period of parent trial.

  • Patients who are currently or wish to participate in another investigational drug trial.

  • Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.

Further exclusion criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Advanced Research Center, Inc. Anaheim California United States 92805
2 Artemis Institute for Clinical Research, LLC San Diego California United States 92103
3 National Research Institute Santa Ana California United States 92704
4 San Marcus Research Clinic, Inc. Miami Florida United States 33014
5 CCM Clinical Research Group, LLC Miami Florida United States 33133
6 Center for Behavioral Health, LLC Gaithersburg Maryland United States 20877
7 Hassman Research Institute Berlin New Jersey United States 08009
8 Neurobehavioral Research, Inc. Cedarhurst New York United States 11516
9 Instituto Médico de la Fundación Estudios Clínicos Rosario Argentina 2000
10 The sixth People's Hospital of Hebei Province Baoding China 71000
11 Beijing Anding Hospital Beijing China 100088
12 Peking University Sixth Hospital Beijing China 100089
13 The Affiliated Brain Hospital of Guangzhou Medical University Guangzhou China 510370
14 The Affiliated Hospital of Guizhou Medical University Guiyang China 550000
15 Huzhou Third Municipal Hospital Huzhou China 313000
16 Shandong Daizhuang Hospital Jining China 272051
17 Ningbo Kangning Hospital Ningbo China 315201
18 Shenzhen Kangning Hospital Shenzhen China 518003
19 The Second Affiliated Hospital of Xinxiang Medical Univ. Xinxiang China 453002
20 HOP la Colombière Montpellier France 34295
21 HOP Nord Saint Priest en Jarez France 42270
22 Zentrum für klinische Forschung Dr. Schöll, Dr. Steidl & Kollegen Bad Homburg Germany 61348
23 Praxis Dr. Hahn, Berlin Berlin Germany 13187
24 Klinikum der Universität München - Campus Innenstadt München Germany 80336
25 Azienda Sanitaria Ospedale S. Luigi Gonzaga Orbassano (to) Italy 10043
26 Uematsu Mental Clinic Fukuoka, Chikugo Japan 833-0041
27 Kuramitsu Hospital Fukuoka, Fukuoka Japan 819-0037
28 Yuge Neuropsychiatric Hospital Kumamoto, Kumamoto Japan 861-8002
29 Suwa Red Cross Hospital Nagano, Suwa Japan 392-8510
30 Nara Medical University Hospital Nara, Kashihara Japan 634-8522
31 National Hospital Organization Hizen Psychiatric Medical Center Saga, Kanzaki-gun Japan 842-0192
32 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
33 Chonnam National University Hospital Gwangju Korea, Republic of 61453
34 Seoul National University Bundang Hospital Gyeonggi-Do Korea, Republic of 13620
35 Pusan National University Yangsan Hospital Yangsan Korea, Republic of 626-770
36 BIND Investigaciones S.C. San Luis Potosi Mexico 78213
37 NCKUH Tainan Taiwan 704
38 National Taiwan University Hospital Taipei Taiwan 10016
39 Taoyuan Psychiatric Center Taoyuan Taiwan 33058
40 Chang Gung Memorial Hospital(Linkou) Taoyuan Taiwan 330

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05211947
Other Study ID Numbers:
  • 1346-0014
  • 2020-003745-11
First Posted:
Jan 27, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Schizophrenia
BI 425809

Study Results

No Results Posted as of Aug 23, 2022