CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia

Prior treatment

• History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
• Positive urine drug screen.
• Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
• Current participation in any investigational drug trial.
• Cognitive Remediation Therapy within 12 weeks prior to screening.
• Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.

Other illness

• Cognitive impairment due to other causes, or patients with dementia or epilepsy.
• Severe movement disorders.
• Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
• Severe renal impairment.
• Indication of liver disease.
• Any documented active or suspected malignancy or history of malignancy within 5 years.

Lab values

• Haemoglobin (Hb) below lower limit of normal .
• History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.

Other

• Patient with current DSM-5 diagnosis other than Schizophrenia.
• Any suicidal behavior in past year or suicidal ideation in the past 3 months.
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Further exclusion criteria apply.

• Signed and dated written informed consent.
• Male or female patients who are 18-50 years (inclusive) of age at time of consent.
• Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
  • \-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
• Patients should have functional impairment in day-to-day activities per investigator judgement.
• Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
• Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
• 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.