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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.
Show all 9Show fewer
  • 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

Other trials in United States

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

Other trials in China

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

Other trials in Argentina

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

Other trials in Taiwan

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

Other trials in United Kingdom

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

Other trials in Mexico

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

Other trials in Czechia

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

Other trials in South Korea

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

Other trials in Germany

Belgium4 sites

  • CUP Vivalia -La Clairière

    Bertix, 6880

  • Sint-Kamillus

    Bierbeek, 3360

  • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

    Duffel, 2570

  • Meclinas

    Mechelen, 2800

Other trials in Belgium

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

Other trials in Lithuania

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

Other trials in Bulgaria

Denmark3 sites

  • Aalborg Universitetsshospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Psykiatrisk Center Glostrup

    Glostrup Municipality, 2600

Other trials in Denmark

Finland3 sites

  • HUS Jorvi Hospital

    Espoo, 2740

  • Aurora hospital

    Helsinki, 00250

  • CRST - Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

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

Other trials in Portugal

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

Other trials in Serbia

Brazil2 sites

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

  • Clínica Viver - Centro de Desospitalização Humana

    São Paulo, 04020-060

Other trials in Brazil

Austria1 site

  • AKH - Medical University of Vienna

    Vienna, 1090

Other trials in Austria

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 groups in NCT04860830
Study groupRoleWhat they receive
Iclepertin 10 mgExperimentalPatients 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
PlaceboPlacebo comparatorPatients 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.

  1. 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)

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  1. First posted27 Apr 2021
  2. Study start9 Aug 2021
  3. Primary completion28 Oct 2024
  4. Study completion20 Nov 2024

Resources

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)
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
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

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.

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