Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

A Phase III Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)

This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Iclepertin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 611
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, 1058AAJ
    • CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)
  • CABA, Argentina, 1111
    • SERES Neurociencia Cognitiva Aplicada
  • CABA, Argentina, C1405BOA
    • Fundación FunDaMos para la asistencia e investigación en psiquiatría
  • Córdoba, Argentina, X5009
    • Sanatorio Morra S.A.
  • Córdoba, Argentina, 5004
    • CEN (Centro Especializado Neurociencias)
  • La Plata, Argentina, 1900
    • Clinica Privada de Salud Mental Santa Teresa de Ávila
  • Mendoza, Argentina, 5502
    • Resolution Psychopharmacology Research Institute
  • Rosario, Argentina, S2000QJI
    • Centro de Investigación y Asistencia en Psiquiatría (CIAP)
• Brazil
  • Rio de Janeiro, Brazil, 22270-060
    • Ruschel Medicina e Pesquisa Clínica
  • São Bernardo do Campo, Brazil, 09715-090
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clinica Ltda
  • São Paulo, Brazil, 04020-060
    • Clinica Viver - Centro de Desospitalizacao Humana
  • São Paulo, Brazil, 05403-010
    • Hospital das Clínicas da FMUSP
• Chile
  • Santiago, Chile, 7500710
    • Biomedica Research Group
  • Segunda Región, Chile, 1270244
    • Psicomed Estudios Clínicos
• Croatia
  • Rijeka, Croatia, 51 000
    • Clincal Hospital Centre Rijeka
  • Zagreb, Croatia, 10 000
    • Clinical Hospital Centre Zagreb
  • Zagreb, Croatia, 10090
    • University Psychiatric Hospital Vrapce
  • Zagreb, Croatia, 10090
    • Psychiatric Hospital 'Sveti Ivan'
  • Zagreb, Croatia, 10000
    • Solmed Polyclinic
• France
  • Bordeaux, France, 33076
    • HOP Charles Perrens
  • Clermont-Ferrand, France, 63003
    • HOP Gabriel-Montpied
  • Créteil, France, 94000
    • HOP Albert Chenevier
  • Le Chesnay-Rocquencourt, France, 78150
    • HOP André Mignot
  • Lille, France, 59037
    • HOP Fontan
  • Montpellier, France, 34295
    • HOP la Colombière
  • Nantes, France, 44093
    • HOP Hôtel-Dieu
  • Nice, France, 06000
    • HOP Pasteur
  • Nîmes, France, 30029
    • HOP Carémeau
  • Rennes, France, 35703
    • HOP Guillaume Régnier
  • Rouffach, France, 68250
    • HOP Rouffach
  • Saint-Priest-en-Jarez, France, 42270
    • HOP Nord-Saint-Priest-en-Jarez-53664
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis University
  • Budapest, Hungary, 1036
    • Obudai Egeszegugyi Centrum Kft.
  • Debrecen, Hungary, 4031
    • University of Debrecen, Gyula Kenezi University Hospital
  • Pécs, Hungary, 7633
    • PsychoTech Ltd.
• Japan
  • Aichi, Toyoake, Japan, 470-1168
    • Okehazama Hospital Fujita Kokoro Care Center
  • Aichi, Toyota, Japan, 471-8513
    • Toyota Memorial Hospital
  • Chiba, Chiba, Japan, 266-0007
    • National Hospital Organization Shimofusa Psychiatric Medical Center
  • Fukuoka, Chikugo, Japan, 833-0041
    • Uematsu Mental Clinic
  • Fukuoka, Fukuoka, Japan, 810-0031
    • AK Clinic
  • Fukuoka, Kurume, Japan, 830-0033
    • Hirota Clinic
  • Gumma, Kiryu, Japan, 376-0011
    • Kishi Hospital
  • Hokkaido, Sapporo, Japan, 001-0010
    • Hokudai-dori Mental Health Clinic
  • Hyogo, Kobe, Japan, 651-0097
    • Tatsuta Clinic
  • Ishikwa, Kahoku-gun, Japan, 920-0293
    • Kanazawa Medical University Hospital
  • Kanagawa, Kawasaki, Japan, 214-0014
    • Kishiro Mental Clinic
  • Kanagawa, Yokohama, Japan, 236-0004
    • Yokohama City University Hospital
  • Kanagawa, Yokohama, Japan, 224-0001
    • Links Mental Clinic
  • Kumamoto, Kumamoto, Japan, 861-8002
    • Yuge Neuropsychiatric Hospital
  • Kumamoto, Yatsushiro, Japan, 866-0043
    • Medical Corporation Yamadakai Yatsushiro Welfare Hospital
  • Nagano, Suwa, Japan, 392-8510
    • Suwa Red Cross Hospital
  • Nara, Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Okinawa, Ginowan, Japan, 901-2725
    • University of the Ryukyus Hospital
  • Osaka, Osaka, Japan, 534-0021
    • Osaka City Hospital Organization Osaka City General Hospital
  • Saga, Karatsu, Japan, 847-0031
    • Rainbow and Sea Hospital
  • Saga, Tosu, Japan, 841-0081
    • Inuo Hospital
  • Tokyo, Adachi-ku, Japan, 121-8515
    • Medical Corporation Seijin Hospital
  • Tokyo, Bunkyo-ku, Japan, 113-8519
    • Institute of Science Tokyo Hospital
  • Tokyo, Kita-ku, Japan, 114-0024
    • Nishigahara Hospital
  • Tokyo, Minato-ku, Japan, 107-0062
    • Minami-Aoyama Antique Street Clinic
  • Tokyo, Ota-ku, Japan, 143-8541
    • Toho University Omori Medical Center
  • Tokyo, Shibuya-ku, Japan, 151-0053
    • Maynds Tower Mental Clinic
  • Tokyo, Shinjuku-ku, Japan, 160-0021
    • Shinjuku East Mental Clinic
  • Toyama, Nanto, Japan, 939-1893
    • Hokuriku Hospital
• Malaysia
  • Ipoh, Malaysia, 30450
    • Hospital Raja Permaisuri Bainun
  • Kuala Lumpur, Malaysia, 59100
    • University of Malaya Medical Centre
  • Kuching, Malaysia, 93250
    • Hospital Sentosa
  • Seremban, Negeri Sembilan, Malaysia, 70300
    • Hospital Tuanku Ja'afar
• Netherlands
  • Groningen, Netherlands, 9713 AV
    • Universitair Medisch Centrum Groningen
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University
• Poland
  • Bełchatów, Poland, 97-400
    • Psychiatric Doctor's Office Ireneusz Kaczorowski
  • Bialystok, Poland, 15-756
    • Podlassian Center of Psychogeriatry, Bialystok
  • Gdansk, Poland, 80-283
    • Health Center Alcea
  • Gliwice, Poland, 44100
    • MentalMEDIC
  • Gmina Świecie, Poland, 86-100
    • Provincial Hospital for Nervous and Mentally Ill in Swiecie
  • Szczecin, Poland, 70-111
    • EUROMEDIS Sp. z o.o., Szczecin
  • Zabrze, Poland, 41-807
    • Clinhouse
• Romania
  • Bucharest, Romania, 040872
    • Mental Health Center Sector 4
  • Sibiu, Romania, 557260
    • SC Carpe Diem SRL
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Mental Health
  • Novi Kneževac, Serbia, 23330
    • Special Hospital for Psychiatric Diseases Sveti Vračevi
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina
• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 539747
    • Institute of Mental Health
• Slovakia
  • Bojnice, Slovakia, 97201
    • Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
  • Košice, Slovakia, 040 01
    • EPAMED s.r.o.
  • Rimavská Sobota, Slovakia, 97901
    • Psychiatricka Ambulancia Psycholine S.R.O.
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, South Korea, 42472
    • Daegu Catholic University Medical Center
  • Incheon, South Korea, 400 711
    • Inha University Hospital
  • Jeonju, South Korea, 54907
    • Chonbuk National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08025
    • Hestia Palau
  • Collado de Villalba, Spain, 28400
    • Hospital Universitario General de Villalba
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Getafe, Spain, 28903
    • Centro de Salud mental de Getafe
  • Majadahonda, Spain, 28222
    • Hospital Puerta de Hierro
  • Palma, Spain, 07198
    • Hospital de Son Llàtzer
  • Salamanca, Spain, 37005
    • Centro de Salud de San Juan
  • Sant Boi de Llobregat, Spain, 08830
    • Benito Menni Complejo Asistencial en Salud Mental
  • Seville, Spain, 41013
    • Hospital Virgen Del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Vigo, Spain, 36211
    • Hospital Nicolás Peña
  • Zamora, Spain, 49021
    • Hospital Provincial. Complejo Asistencial de Zamora
• Ukraine
  • Nove, Ukraine, 25491
    • Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council
• United States
  • California
    • Bellflower, California, United States, 90706
      • Clinical Innovations, Inc
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Long Beach, California, United States, 90807
      • ASCLEPES Research Centers, P.C. dba Alliance Research
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Torrance, California, United States, 90504
      • Collaborative Neuroscience Research, LLC-Torrance-69527
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center
  • Florida
    • Hialeah, Florida, United States, 33013
      • Research in Miami Inc
    • Miami, Florida, United States, 33135
      • Optimus U Corporation-Miami-69452
    • West Palm Beach, Florida, United States, 33407
      • Health Synergy Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • American Medical Research
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Sheppard Pratt Physicians's Practice Association, Inc.
  • Missouri
    • St Louis, Missouri, United States, 63128
      • PsychCare Consultants Research
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc.
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute
  • Ohio
    • Independence, Ohio, United States, 44131
      • Insight Clinical Trials, LLC, Independence
  • Texas
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials, LLC
    • Fort Worth, Texas, United States, 76104
      • John Peter Smith Health Network
  • Virginia
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Patient must be capable of providing a signed and dated written informed consent by visit 1 in accordance with International Council on Harmonisation for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
2. Male or female patients who are 18-50 years (inclusive) of age at time of consent.

3. Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) with the following clinical features:

   • Outpatient, clinically stable and in the residual (non-acute) phase of their illness.
   • No hospitalization3 or increase in level of psychiatric care4 due to worsening of schizophrenia within 12 weeks prior to randomization.
   • Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 = 5 and item P2 and P7 = 4 at Visit 1, and confirmed at Visit 2.
4. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties staying focused, difficulties remembering instructions, what to say or how to get to places, per investigator judgement.

5. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization.

   -- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label.

   Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic.

6. 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.

   • Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent as needed.
   • For any other psychoactive medications cannot exceed the maximum daily dose per local label of the country where the study is being conducted.
7. Women of childbearing potential (WOCBP)5 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. A list of contraception methods meeting these criteria is provided in the protocol. 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.

8. Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interacting with the patient on regular basis, and preferably consistent throughout the study.

   • The study partner must interact with the patient at a minimum one hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person.
   • The study partner must have educational achievement of minimum 8th grade.
   • Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments.

Further inclusion criteria apply.

Exclusion criteria

1. Patient with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. The Mini-International Neuropsychiatric Interview (M.I.N.I.) for psychotic disorders should be used for guidance.
2. Cognitive impairment due to developmental, neurological (e.g. stroke) or other disorders including head trauma, or patients with dementia or epilepsy.

3. Severe movement disorders

   • Leading to cognitive impairment (e.g. Parkinson's dementia), or
   • Interfering with the efficacy assessments, or
   • Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily).
4. Any suicidal behavior in the past 1-year prior to screening and during the screening period.

5. Suicidal ideation of type 5 in the Columbia Suicidality Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2.

   -- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide.

6. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent.
7. Positive urine drug screen at Visit 1 based on central lab test.

8. Patients who were treated with any of the following within 6 months prior to randomization:

   • Clozapine
   • Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
   • Ketamine or esketamine
   • Electroconvulsive therapy (ECT) or modified ECT Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iclepertin 10 mg; This arm comprised participants who received 10 mg tablet of iclepertin orally once daily, with doses administered at least 24 hours (hrs) apart, taken with water. Participants were treated for 26 weeks, followed by 4 weeks follow-up after trial drug termination.	Drug: Iclepertin; One tablet of 10 mg iclepertin taken once daily for 26 weeks; Other Names: BI 425809
Placebo Comparator: Placebo; This arm comprised participants who received 10 mg tablet of iclepertin-matched Placebo orally once daily, with doses administered at least 24 hrs apart, taken with water. Participants were treated for 26 weeks, followed by 4 weeks follow-up after trial drug termination.	Drug: Placebo; One tablet of matching placebo taken once daily for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Overall Composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 26 Weeks of Treatment	The change from baseline in MCCB (MATRICS Consensus Cognitive Battery) overall composite T-score at Week 26 is reported. This was analyzed using a mixed-effects model for repeated measurements (MMRM) comparing the change from baseline in MCCB overall composite T-score at Week 26 between iclepertin 10 mg daily and placebo. The MCCB comprises 10 tests to measure cognitive performance in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite T-score is derived from the 7 cognitive domain T-scores. The T-score is standardized to the normative population with a mean of 50 and standard deviation of 10. A higher MCCB overall composite T-score indicates better cognition.	The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in SCoRS (Schizophrenia Cognition Rating Scale) Interviewer Total Score at Week 26	SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale, ranging from "No impairment" to "Severe Impairment", with higher ratings reflecting a greater degree of impairment. The SCoRS rater integrates information from separate patient and study partner interviews to generate a total score. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. The total score was the sum of the 20 item scores. If six or more of the 20 items were missing, the total score was not derived and treated as missing for that participant at the visit, otherwise, missing items were imputed with the mean of the observed items for the purpose of total score calculation.	The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.
Change From Baseline in VRFCAT (Virtual Reality Functional Capacity Assessment Tool) Adjusted Total Time T-score at Week 26	The VRFCAT is a virtual reality shopping trip performed on a tablet. The task has several linked and sequential scenarios, including matching a recipe to the content of kitchen cabinets, preparing a shopping list, taking the correct bus, shopping efficiently, and catching the correct return bus. These tasks are performed in a fixed sequence. The tool records the total amount of time taken to complete the sequence of tasks, adjusting for number of errors and forced progressions. A T-score is generated from this adjusted total time. The lower the adjusted total time T-score, the better is the patient's functional capacity. The T-score has a mean of 50 and a standard deviation of 10 in the normative population.	The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.
Change From Screening Visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score	The Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) score evaluates how cognitive difficulties impact the daily life of individuals with schizophrenia. It is composed of 28 items on a 5-category Likert scale (1=not at all/not at all hard, 5=very much/very hard), and the total score was derived by calculating the average score of the first 26 items, where higher scores indicate a worse patient experience. The questionnaire takes 5-15 minutes to complete and provides insights into cognitive impairment associated with schizophrenia (CIAS) impact.	The MMRM model is a longitudinal analysis which incorporated values at screening, and at Week 15 and Week 24. The data presented here represent the Least Squares Mean at Week 24.
Change From Baseline in the T-score of the Number of Correct Responses on Tower of London (ToL) at Week 26	Change from baseline in the T-score of the number of correct responses on Tower of London at Week 26, using an analysis of covariance (ANCOVA) model, is reported. The Tower of London evaluates executive functions such as reasoning and problem-solving ability. It measures the number of correct responses in solving an exercise that involves moving colored balls to match a target configuration. The higher the ToL T-score, the better is the patient's cognitive function. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in the normative population. The administration time was about 7 minutes.	Baseline and at Week 26

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Keefe RSE, Harvey PD, Correll CU, Falkai P, Hashimoto N, Klein H, Krystal JH, Marder S, Medalia A, Sumiyoshi T, Wang G, Zhang H, Blahova Z, Bichard-Sall I, English BA, Fu E, Gruenenfelder F, Groeschl M, Kimura K, Tang W, von der Goltz C, Fowler C. Efficacy and safety of iclepertin for cognitive impairment associated with schizophrenia (CONNEX programme): results from three phase 3 randomised controlled trials. Lancet Psychiatry. 2025 Dec;12(12):906-920. doi: 10.1016/S2215-0366(25)00296-2.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): November 17, 2024

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; BI 425809
• Other Study ID Numbers: 1346-0012; 2020-003744-84 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No