1346-0013 Phase III BI 425809 Vs placebo in schizophrenia CONNEX-3

• Research type

  Research Study

• Full title

  A phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily over 26 week treatment period in patients with schizophrenia (CONNEX-3)

• IRAS ID

  293430

• Contact name

  Lilian Duah

• Contact email

  businesssupport.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Limited

• Eudract number

  2020-003726-23

• Clinicaltrials.gov Identifier

  NCT04860830

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  2 years, 5 months, 10 days

• Research summary

  This trial is investigating BI 425908 as a treatment for cognitive
  impairment due to schizophrenia and will be conducted in about 100
  sites across multiple countries. After giving Informed Consent and successful completion of the screening period, eligible patients will be allocated equally at random to received either the study drug – 10mg BI 425809 - or placebo, once daily, for a 26 week treatment period. Neither the study team, the sponsor team, nor the patient will be aware of which arm of the treatment the patient is on.

  In total, approximately 586 patients with schizophrenia on stable antipsychotic treatment who meet the eligibility criteria are planned to enter the study, 50% will enter the active arm, and 50% will enter the placebo arm.

  Patients in each arm of the study will be stratified by MCCB overall composite T-score at screening (screening MCCB overall composite T-score < 30, ≥ 30) via Interactive Response Technology (IRT) to balance the baseline cognitive level among groups.

  All patients who finish 26 weeks of treatment with BI 425809 or placebo in this study, will be offered the opportunity for treatment with open label BI 425809 10 mg in a long-term safety extension trial.
  Eligible patients may enter the extension trial, preferably after completing the EOT visit, or alternatively within 14 days from EoT. Subjects who do not enroll in the extension study will be followed up for safety for an additional period of 4 weeks after their last dose of medication.

  Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.mystudywindow.com%252Ftrials%252Fdisease%252Fcompleted%252F-1%252FAll%253FtrialId%253D1346-0013%2FNBTI%2FR1rBAQ%2FAQ%2Faa56eb27-8a06-43af-931c-b737e15bedfe%2F1%2FWI9fd4Bm4v&data=05%7C02%7Ctyneandwearsouth.rec%40hra.nhs.uk%7C0d3343c306f1468e264c08de22b3c56f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638986352665396860%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Bk0YmJ7%2BkcotMfFy4WgRYH5lDt6GY3eBQJMWFsGwYmo%3D&reserved=0
  

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  21/NE/0225

• Date of REC Opinion

  13 Jan 2022

• REC opinion

  Further Information Favourable Opinion