A study to test long-term safety of Iclepertin in people with schizophrenia who took part in a previous CONNEX study
- Conditions
- SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-003745-11-NL
- Lead Sponsor
- Boehringer Ingelheim bv Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1401
1. Signed and dated written informed consent in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial (Visit 1).
2. Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)).
3. Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial within:
• Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013.(i.e. Follow Up 1 timepoint including the applicable time windows).
• At the end of safety follow up in 1346-0012.(within 7 days of visit Follow Up 6).
4. Women of childbearning potential (WOCBP) must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial.
5. Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on regular basis (at least once a week, either private or professional). Study partner does not need to attend visits with the patient but must be reachable by phone. Study partner should preferably be the same person throughout the study, if possible
• Professional study partner (e.g. study nurse, social worker etc.) are allowed if not involved in administering any of the protocol assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1401
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Participant who developed DSM5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial (e.g. stroke, head trauma, developed dementia, severe uncontrolled movement disorders or other significant condition since enrolment into the parent phase III trial).
2. Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study.
o Patients with Suicidal Ideation type 4 in the C-SSRS (active suicidal thought with intent but without specific plan), in the past 3 months prior to and including Visit 1, can be entered in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.
3. Patients diagnosed with moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 while the patient was in parent trial and prior to Visit 1 of this study.
4. Positive urine drug screen = 3 times during the parent trial based on central lab test.
5. Patients who are currently or wish to participate in another investigational drug trial.
6. Any clinically significant finding in the judgment of the investigator such as :
o Clinically significant finding on he Physical examination and/or ECG from the last assessment done in the parent trial.
o Vital signs (including blood pressure (BP) and pulse rate (PR)) that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
o Symptomatic/unstable/uncontrolled or clinically relevant concomitant disease or any other clinical condition that would jeopardize the patient´s safety while participating in the trial or capability to participate in the trial.
o Significant or unstable physical condition that may require change in medication or hospitalization that would impact cognitive function.
7. Any significant central lab findings based on the last available lab result received during the parent trial such as:
o Severe renal impairment defined as an eGFR < 30mL/min/1.73m²,
o Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 times upper limit or normal or
o Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial)
o Patients who meet any of the withdrawal criteria before planned end of treatment (26 weeks) in parent trial.
8. Patients who have been diagnosed with hemoglobinopathies during the parent trial.
9. Patients with known ongoing severe or serious infection with SARS-CoV-2.
10. Known history of HIV and/or known on-going Hepatitis B or C infections. As well as any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
11. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
12. Patients with an allergy to BI 425809 and/or any of the excipients (including serious lactose intolerance).
13. Patients who are currently treated or expected to be treated with any of the following: strong or moderate CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, CYP3A4 sensitive substrates,. including grapefruit juice ad St. John’s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with BI 425809 or matching placebo of one of the phase III clinical trial program for BI 425809 (trial # 1346-0011, 1346-0012, 1346-0013).;Secondary Objective: Not applicable;Primary end point(s): 1) occurrence of treatment emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: 1) 54 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Change from baseline in CGI-S to end of treatment.<br>2) Change from baseline in hemoglobin to end of treatment.<br>;Timepoint(s) of evaluation of this end point: 1) 52 weeks<br>2) 52 weeks