SchizophreniaPhase 3NCT04860830
CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
A Phase 3 study testing Iclepertin in people with Schizophrenia, run by Boehringer Ingelheim at 110 sites in 18 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Iclepertin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 609 participants
- Where
- 110 sitesin 18 countries
- Study dates
- 9 Aug 2021to 20 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Patient with current DSM-5 diagnosis other than Schizophrenia.
- Cognitive impairment due to other causes, or patients with dementia or epilepsy.
- Severe movement disorders.
- Any suicidal behavior in past year or suicidal ideation in the past 3 months.
- History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
- Positive urine drug screen.
Show all 18Show fewer
- 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.
- 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.
- 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.
- Severe renal impairment.
- Indication of liver disease.
- Any documented active or suspected malignancy or history of malignancy within 5 years.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Further exclusion criteria apply.
Trial locations and contacts
110 sites in 18 countries.
110 sites in 18 countries
United States24 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Synexus Clinical Research-Atlanta-67262
Atlanta, Georgia, 30328
Augusta University
Augusta, Georgia, 30912
Hassman Research Institute-Berlin-60540
Berlin, New Jersey, 08009
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research
Dayton, Ohio, 45417
Center for Behavioral Health, LLC
Gaithersburg, Maryland, 20877
Advanced Medical Research Group Inc
Hollywood, Florida, 33021
Ben Taub General Hospital
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90095
Accel Research Sites Network
Maitland, Florida, 32751
University of Miami
Miami, Florida, 33136
Ivetmar Medical Group, LLC
Miami, Florida, 33155
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, 73112
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
Omaha Insomnia and Psychiatric Services
Omaha, Nebraska, 68144
Nova Psychiatry Inc.
Orlando, Florida, 32803
CNRI - Los Angeles
Pico Rivera, California, 90660
UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
Raleigh, North Carolina, 27608
LinQ Research, LLC-Richmond-70076
Richmond, Texas, 77407
Arch Clinical Trials, LLC
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94304
Oasis Life Care
State College, Pennsylvania, 16801
Sunwise Clinical Research-Walnut Creek-70166
Walnut Creek, California, 94596
China11 sites
Beijing Anding Hospital
Beijing, 100088
The Second Xiangya Hospital Of Central South University
Changsha, 410011
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
Huzhou Third Municipal Hospital
Huzhou, 313000
Nanjing Brain Hospital
Nanjing, 210029
Shenzhen Kangning Hospital
Shenzhen, 518003
The First Hospital of Hebei Medical University
Shijiazhuang, 050030
Tianjin Anding Hospital
Tianjin, 300222
First Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710061
Xi'an Mental Health Center
Xi'an, 710101
Zhumadian Psychiatric Hospital
Zhumadian, 463000
Argentina9 sites
Clínica Privada Banfield
Banfield, B1828CKR
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
CABA, C1133AAH
Fundación FunDaMos para la asistencia e investigación en psiquiatría
CABA, C1405BOA
CEN (Centro Especializado Neurociencias)
Córdoba, 5004
Instituto Modelo de Neurología Lennox
Córdoba, X5000FAL
Instituto Médico DAMIC S.R.L.
Córdoba, X5003DCE
Instituto de Neurociencias San Agustín
La Plata, 1900
Instituto Médico de la Fundación Estudios Clínicos
Rosario, 2000
Centro Medico Luquez
San Vicente, X5006CBI
Taiwan8 sites
Kai-Syuan Psychiatric Hospital
Kaohsiung City, 802
Chang Gung Memorial Hospital-Keelung
Keelung, 204
Chung Shan Medical University Hospital
Taichung, 40201
NCKUH
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Taoyuan Psychiatric Center
Taoyuan, 33058
Chang Gung Memorial Hospital, Linkou
Taoyuan County, 333
United Kingdom8 sites
Bodmin Community Hospital
Bodmin, PL31 2QT
The Fritchie Centre
Cheltenham, GL53 9DZ
Redesmere
Chester, CH2 1BQ
Western General Hospital
Edinburgh, EH4 2XU
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Maudsley Hospital
London, SE5 8AZ
Warneford Hospital
Oxford, OX3 7JX
Moorgreen Hospital
Southampton, SO30 3JB
Mexico7 sites
Centro de Investigacion Integral MEDIVEST S.C
Chihuahua City, 31203
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, 80230
Hospital Aranda de la Parra
León, 37000
Centro de Investigación Clinica Acelerada, S.C.
Mexico City, 07369
Iecsi S.C.
Monterrey, 64310
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
BIND Investigaciones S.C.
San Luis Potosí City, 78213
Czechia6 sites
National Institute of Mental Health
Klecany, 25067
MP Meditrine s.r.o.
Ostrava, 708 00
A-SHINE s.r.o
Pilsen, 30100
PRAGTIS s.r.o.
Prague, 120 00
INEP medical s.r.o.
Prague, 18600
Psychiatrie Ricany s.r.o.
Říčany, 251 01
South Korea6 sites
Inje University Busan Paik Hospital
Busan, 47392
Yeungnam University Medical Center
Daegu, 705-717
Chonnam National University Hospital
Gwangju, 61453
Seoul National University Bundang Hospital
Seongnam, 13620
CHA Bundang Medical Center
Seongnam-si, 13496
Pusan National University Yangsan Hospital
Yangsan, 50612
Germany5 sites
Studienzentrum für Neurologie und Psychiatrie
Böblingen, 71034
LWL-Klinik Dortmund
Dortmund, 44287
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Klinikum der Universität München - Campus Innenstadt
München, 80336
Universitätsklinikum Tübingen
Tübingen, 72076
Belgium4 sites
CUP Vivalia -La Clairière
Bertix, 6880
Sint-Kamillus
Bierbeek, 3360
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
Duffel, 2570
Meclinas
Mechelen, 2800
Lithuania4 sites
JSC Romuvos Clinic
Kaunas, LT-44279
LUHS KH Psichiatric Clinic Mariu Division
Kaunas, LT-53137
JSC Medical center "Puriena"
Šilutė, LT-99142
Vilnius City Mental Health Center
Vilnius, LT-10309
Bulgaria3 sites
Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
Plovdiv, 4000
Medical Center "Spectar"
Plovdiv, 4000
Medical Center Hera EOOD
Sofia, 1510
Denmark3 sites
Aalborg Universitetsshospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
Psykiatrisk Center Glostrup
Glostrup Municipality, 2600
Finland3 sites
HUS Jorvi Hospital
Espoo, 2740
Aurora hospital
Helsinki, 00250
CRST - Clinical Research Services Turku
Turku, 20520
Portugal3 sites
ULS da Região de Leiria, E.P.E.
Leiria, 2410-197
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
ULS de Loures-Odivelas, E.P.E
Loures, 2674-514
Serbia3 sites
Clinical Hospital Center Dr. Dragisa Misovic
Belgrade, 11000
General Hospital Euromedik
Belgrade, 11000
Special Hospital for Psychiatric Diseases Gornja Toponica
Gornja Toponica, 18202
Brazil2 sites
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Clínica Viver - Centro de Desospitalização Humana
São Paulo, 04020-060
About this study
Official title: 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-3)
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.
Read more
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 and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
- Conditions
- Schizophrenia
- Being tested
- Iclepertin, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IclepertinDrug
Also called BI 425809
One tablet of 10 mg once daily for 26 weeks.
PlaceboDrug
One tablet once daily for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Iclepertin 10 mg | Experimental | Patients with schizophrenia took one tablet of 10 milligram (mg) iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria. Receives: Drug: Iclepertin |
| Placebo | Placebo comparator | Patients with schizophrenia took one tablet of placebo matching iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 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 MCCB assesses 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. T-scores in the general population have a mean of 50 and standard deviation of 10, and a higher score indicates better cognition. The primary analysis was a restricted maximum likelihood (REML) based approach using a mixed-effects model for repeated measurements (MMRM), which included the fixed categorical effects of treatment at each visit, fixed categorical effect of the stratification factor using the screening MCCB overall composite T-score, and a fixed effect for the continuous covariate of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-subject dependencies. Intercurrent events were addressed using different pre-defined strategies.
Measured: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
Secondary outcomes (6)
Change From Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Score After 26 Weeks of Treatment
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. Higher ratings reflect a greater degree of impairment. The interviewer integrates information from separate patient and study partner interviews to generate a total score, which ranges from 20 to 80. The analysis was a REML-based approach using a MMRM model, which included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, a fixed effect for the continuous covariate of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect. Intercurrent events were addressed using different pre-defined strategies.
Measured: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
Change From Baseline to Week 26 in the Adjusted Total Time T-score in Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
The VRFCAT is a virtual reality shopping trip performed on a tablet, and was used as an electronic Functional Capacity measure by measuring the total time adjusting for the number of errors. T-scores in the general population have a mean of 50 and standard deviation of 10, and a higher score indicates a better functional outcome. The analysis was a REML-based approach using a MMRM model, which included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, a fixed effect for the continuous covariate of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect. Intercurrent events were addressed using different pre-defined strategies.
Measured: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
Change From Baseline to Week 26 in the T-score of the Number of Correct Responses on Tower of London
This is an Executive Functions/Reasoning and Problem Solving test where patients were shown two images on opposite sides of a tablet screen. Each image showed a different configuration of 3 colored balls arranged on 3 pegs. Patients were required to accurately determine the total number of times the balls in one picture would have to be moved in order to make the arrangement of balls identical to that of the other opposing picture, while employing the standard rules employed in tower tests. T-scores in the general population have a mean of 50 and standard deviation of 10, and a higher score indicates a better outcome. The analysis was performed with an analysis of covariance (ANCOVA) model, which included treatment, stratification factor of screening MCCB overall composite T-score (< 30, ≥ 30), and baseline number of correct responses on Tower of London T-score.
Measured: At baseline (Week 0) and at Week 26.
Change From Screening Visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score
PRECIS consists of 26 items covering 6 domains (memory, communication, self-control, executive function, attention, and sharp thinking), and 2 additional items assessing the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores indicating a worse patient experience. The total score, ranging from 26 to 130, is the average score of the first 26 items. The analysis was a REML-based approach using a MMRM model, which included the discrete fixed effects of treatment at each visit, fixed categorical covariate of the stratification factor using the screening MCCB overall composite T-score, and continuous fixed effects for the corresponding baseline endpoint value at each visit. Visit was treated as the repeated measure with an unstructured covariance structure to model the within-subject measurements. Subjects were considered as a random effect. Intercurrent events were addressed using different pre-defined strategies.
Measured: The MMRM model incorporates values from baseline (screening), Week 15 and Week 24. The data represent the Least Squares Means at Week 24.
Ocular Safety Sub-study: Change From Baseline in Humphrey Visual Field 24-2 Swedish Interactive Thresholding Algorithm (SITA) Standard at Week 24
The Humphrey visual field is a diagnostic test to measure visual fields, or perimetry. The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a central spot. The perception of these lights is charted and then compared to results of a healthy eye at the same age of the patient to determine if any damage has occurred. Visual field Index goes from 100%= perfect to 0= no vision.
Measured: Measurements were performed at baseline (screening) and at Week 24.
Ocular Safety Sub-study: Change From Baseline in Spectral Domain Ocular Coherence Tomography (OCT)
The central retinal thickness measurements were recorded for each eye via high definition optical coherence tomography (spectral domain OCT) to evaluate the retinal and sub-retinal structures.
Measured: Measurements were performed at baseline (screening) and at Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start9 Aug 2021
- Primary completion28 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860830
- Sponsor's protocol ID
- 1346-0013
- Other IDs
- 2020-003726-23
- Status last verified
- Jan 2026
- First submitted
- 26 Apr 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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". Furthermore, researchers can 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.
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.
PubMed 41233083
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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-3)
- ClinicalTrials.gov ID
- NCT04860830
- Acronym / sponsor ID
- 1346-0013
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iclepertin 10 mg | Experimental | Drug: IclepertinPatients with schizophrenia took one tablet of 10 milligram (mg) iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria. |
| Placebo | Placebo comparator | Drug: PlaceboPatients with schizophrenia took one tablet of placebo matching iclepertin orally once daily for 26 weeks. Patients were permitted to remain on other antipsychotic and psychotropic medications, as specified in the eligibility criteria. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- Patient with current DSM-5 diagnosis other than Schizophrenia.
- Cognitive impairment due to other causes, or patients with dementia or epilepsy.
- Severe movement disorders.
- Any suicidal behavior in past year or suicidal ideation in the past 3 months.
- History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IclepertinAlso: BI 425809One tablet of 10 mg once daily for 26 weeks. | Drug | Iclepertin 10 mg |
| PlaceboOne tablet once daily for 26 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in 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
Time frame: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
The MCCB assesses 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. T-scores in the general population have a mean of 50 and standard deviation of 10, and a higher score indicates better cognition. The primary analysis was a restricted maximum likelihood (REML) based approach using a mixed-effects model for repeated measurements (MMRM), which included the fixed categorical effects of treatment at each visit, fixed categorical effect of the stratification factor using the screening MCCB overall composite T-score, and a fixed effect for the continuous covariate of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-subject dependencies. Intercurrent events were addressed using different pre-defined strategies.
6 secondary outcomes
Change From Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Score After 26 Weeks of Treatment
Time frame: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
Change From Baseline to Week 26 in the Adjusted Total Time T-score in Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time frame: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.
Change From Baseline to Week 26 in the T-score of the Number of Correct Responses on Tower of London
Time frame: At baseline (Week 0) and at Week 26.
Change From Screening Visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score
Time frame: The MMRM model incorporates values from baseline (screening), Week 15 and Week 24. The data represent the Least Squares Means at Week 24.
Ocular Safety Sub-study: Change From Baseline in Humphrey Visual Field 24-2 Swedish Interactive Thresholding Algorithm (SITA) Standard at Week 24
Time frame: Measurements were performed at baseline (screening) and at Week 24.
Ocular Safety Sub-study: Change From Baseline in Spectral Domain Ocular Coherence Tomography (OCT)
Time frame: Measurements were performed at baseline (screening) and at Week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41233083Keefe 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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". Furthermore, researchers can 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.
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A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Schizophrenia, Cerebellar Function
Recruiting
tACS for Working Memory in Schizophrenia
Schizophrenia, Working Memory
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
110 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iclepertin in people with Schizophrenia, run by Boehringer Ingelheim at 110 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, China, Argentina, Taiwan, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 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 (time frame: The MMRM model incorporates values from baseline (Week 0), Week 12 and Week 26. The data represent the Least Squares Means at Week 26.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.