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SchizophreniaPhase 3NCT04846868

Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

A Phase 3 study testing Iclepertin in people with Schizophrenia, run by Boehringer Ingelheim at 116 sites in 17 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
620 participants
Where
116 sitesin 17 countries
Study dates
8 Sep 2021to 1 Oct 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

  • Patients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the admission to the trial.
  • 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) with the following clinical features:
  • Outpatient, clinically stable and in the residual (non-acute) phase of their illness.
  • No hospitalization or increase in level of psychiatric care 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.
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  • Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement.
  • 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.
  • 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.
  • For any other psychoactive medications, doses cannot exceed the maximum daily dose per local label.
  • Women of childbearing potential (WOCBP) 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.
  • 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 subject a minimum 1 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.

Who cannot join

  • Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. Mini International Neuropsychiatric Interview (M.I.N.I.) for Psychotic disorders should be used for guidance.
  • Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy.
  • Severe movement disorders
  • Leading to cognitive impairment (e.g. Parkinson 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).
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  • Any suicidal behavior in the past 1-year prior to screening and during the screening period.
  • Suicidal ideation of type 5 in the Columbia Suicide 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.
  • 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.
  • Positive urine drug screen at Visit 1 based on central lab test.
  • 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.

Trial locations and contacts

116 sites in 17 countries.

116 sites in 17 countries

Japan30 sites

  • Hotei Hospital

    Aichi, Konan, 483-8248

  • Japan Institute for Health Security National Kohnodai Medical Center

    Chiba, Ichikawa, 272-8516

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037

  • Shiranui Hospital

    Fukuoka, Omuta, 836-0004

  • Obihiro-Kosei General Hospital

    Hokkaido, Obihiro, 080-0024

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375

  • Yokohama Onoecho Clinic

    Kanagawa, Yokohama, 231-0015

  • Hino Hospital

    Kanagawa, Yokohama, 234-0051

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • National Hospital Organization Maizuru Medical Center

    Kyoto, Maizuru, 625-8502

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Shounan Hospital

    Nagano, Matsumoto, 390-0847

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • National Hospital Organization Hizen Psychiatric Medical Center

    Saga, Kanzaki-gun, 842-0192

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495

  • Nishi Kumagaya Hospital

    Saitama, Kumagaya, 360-0816

  • Sho Midori Hospital

    Saitama, Saitama, 336-0022

  • Dokkyo Medical University Hospital

    Tochigi, Shimotsuga-gun, 321-0293

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • National Center of Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851

  • Asuka Hospital

    Tokyo, Machida, 194-0005

  • Showa University Karasuyama Hospital

    Tokyo, Setagaya, 157-8577

  • Shinjuku East Mental Clinic

    Tokyo, Shinjuku-ku, 160-0021

  • Ohwa Mental Clinic

    Tokyo, Toshima-ku, 170-0002

  • Yamaguchi University Hospital

    Yamaguchi, Ube, 755-8505

  • University of Yamanashi Hospital

    Yamanashi, Chuo, 409-3898

Other trials in Japan

United States18 sites

  • Atlanta Center

    Atlanta, Georgia, 30331

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • University at Buffalo, The State University of New York

    Buffalo, New York, 14215

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • PeaceHealth Medical Group

    Eugene, Oregon, 97401

  • Core Clinical Research

    Everett, Washington, 98201

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Institute of Living

    Hartford, Connecticut, 06106

  • Houston Mind and Brain

    Houston, Texas, 77055

  • Omega Clinical Trials,LLC

    La Habra, California, 90631

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33014

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida, 33133

  • Neuro-Behavioral Clinical Research

    North Canton, Ohio, 44720

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • Velocity Clinical Research-Santa Ana-68902

    Santa Ana, California, 92704

  • Richmond Behavioral Associates-Staten Island-68636

    Staten Island, New York, 10314

Other trials in United States

China13 sites

  • The sixth People's Hospital of Hebei Province

    Baoding, 71000

  • Peking University Sixth Hospital

    Beijing, 100089

  • Beijing HuiLongGuan Hospital

    Beijing, 100096

  • The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province)

    Changsha, 410007

  • The Affiliated Brain Hospital of Guangzhou Medical University

    Guangzhou, 510370

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550004

  • Shandong Daizhuang Hospital

    Jining, 272051

  • The First Affilliated Hospital Of Kunming of Medical College

    Kunming, 650032

  • The Affilicated Kangning Hospital of Ningbo University

    Ningbo, 315201

  • Shanghai Mental Health Center

    Shanghai, 200030

  • Tongji Hospital, Tongji University

    Shanghai, 200065

  • Wuxi mental health center

    Wuxi, 214151

  • The Second Affiliated Hospital of Xinxiang Medical Univ.

    Xinxiang, 453002

Other trials in China

Brazil7 sites

  • CPN - Centro de Estudos em Neurociências

    Belo Horizonte, 30150-270

  • Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)

    Belo Horizonte,Minas Gerais, 31270901

  • Hospital Sao Jose

    Criciúma, 88811-000

  • Trial Tech- Tecnologia em pesquisa com medicamentos

    Curitiba, 80.240-280

  • J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria

    Goiânia, 74093-040

  • Hospital de Base - Fac Med de Sao Jose do Rio Preto

    São José do Rio Preto, 15090-000

  • BR Trials

    São Paulo, 01236-030

Other trials in Brazil

Greece7 sites

  • Eginition Hospital

    Athens, 11528

  • "Attikon" University General Hospital of Attica

    Chaïdári, 12462

  • Psychiatric Hospital of Attica

    Haidari, 12462

  • AX Mental Health Clinic

    Heraklion, 71305

  • General Oncology Hospital "Agioi Anargyri"

    Nea Kifissia, 14564

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57 010

Other trials in Greece

Mexico6 sites

  • Clinica Cemelli

    Guadalajara, 44660

  • Medical Care & Research SA de CV

    Mérida, 97070

  • GabiPros S.C.

    Mexico City, 07000

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, 14269

  • CIT-Neuropsique S.C

    Monterrey, 64610

  • Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).

    Monterrey, 64710

Other trials in Mexico

Colombia5 sites

  • Centro de Investigación y Proyectos en neurociencia CIPNA

    Barranquilla, 80020

  • E.S.E Hospital Mental de Antioquia

    Bello, 51053

  • Instituto Colombiano del Sistema Nervioso- Clínica Montserrat

    Bogotá, 110121

  • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS

    Bogotá, 111166

  • Psynapsis Salud Mental S.A.

    Pereira, 660003

Other trials in Colombia

Italy5 sites

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • A.O. Fatebenefratelli

    Milan, 20121

  • Ist. San Raffaele Turro

    Milan, 20127

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano (TO), 10043

  • A.O.U. Senese

    Siena, 53100

Other trials in Italy

Poland5 sites

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756

  • Central Teaching Hospital of the Medical University of Lodz

    Lodz, 92-216

  • Individual Specialist Medical Practice Filip Rybakowski

    Poznan, 60-744

  • Institute of Psychiatry and Neurology in Warsaw

    Warsaw, 02-957

  • Clinhouse

    Zabrze, 41-807

Other trials in Poland

Turkey (Türkiye)5 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Ankara University Medical School

    Ankara, 06590

  • Istanbul University

    Istanbul, 34093

  • Dokuz Eylul Universitesi Psikiyatri A.B.D.

    Izmir, 35340

  • Celal Bayar Universitesi Tip Fakultesi

    Manisa, 45030

Other trials in Turkey (Türkiye)

Germany4 sites

  • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH

    Bad Homburg, 61348

  • Praxis Dr. Hahn, Berlin

    Berlin, 13187

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159

  • Neurologie und Psychiatrie / Psychotherapie

    Westerstede, 26655

Other trials in Germany

Canada3 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M6J 1H3

Other trials in Canada

Norway2 sites

  • Sykehuset Østfold HF, avd. Moss

    Moss, N-1535

  • Akershus Universitetssykehus HF

    Oslo, N-0963

Other trials in Norway

Philippines2 sites

  • St. Paul's Hospital-Iloilo City-40765

    Iloilo City, 5000

  • Philippine General Hospital

    Manila, Philippines, 1000

Other trials in Philippines

Sweden2 sites

  • Psykiatriska Kliniken

    Helsingborg, 201 53

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Australia1 site

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

Other trials in Australia

New Zealand1 site

  • North Shore Hospital

    Takpuna Auckland, 0622

Other trials in New Zealand

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-1)

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

    One 10 milligram (mg) tablet once a day.

  • PlaceboDrug

    One tablet once a day.

Study groups in NCT04846868
Study groupRoleWhat they receive
Iclepertin 10 mgExperimentalPatients with schizophrenia took orally once a day one 10 milligram (mg) tablet of iclepertin.
Receives: Drug: Iclepertin
Placebo-matching Iclepertin 10 mgPlacebo comparatorPatients with schizophrenia took orally once a day one tablet of placebo-matching iclepertin.
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

    MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The larger the MCCB overall composite T-score, the better patient cognition. A mean T-score of 50 and a standard deviation of 10 reflects the general population.

    The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on on-treatment periods. On-treatment is defined as the period of first drug administration/first resumed dose after interruption until last drug administration + REP (residual effect period).

    The change from baseline was analyzed with a MMRM (mixed-effects model for repeated measures) with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was the repeated measure.

    Measured: MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported.

Secondary outcomes (6)

  1. Key Secondary Endpoint: Change From Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Score After 26 Weeks of Treatment

    The SCoRS is an interview based- assessment tool to evaluate the cognitive function of individuals with schizophrenia that incorporates the input of the patient, the caregiver and the interviewer. It is composed of 20 items on a 7-point Likert scale, ranging from 20 to 140 points, where a higher score indicates a greater cognitive impairment.

    The estimated treatment effect included the effect of any concomitant therapies and partner change in SCoR assessment for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.

    The change from baseline was analyzed with mixed-effects model for repeated measures (MMRM) with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.

    Measured: MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported.

  2. Key Secondary Endpoint: Change From Baseline to Week 26 in the Adjusted Total Time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

    The VRFCAT is a computerized assessment measuring the functional capacity of an individual to perform everyday tasks. It generates a composite score based on the amount of time taken to complete the tasks. The lower the VRFCAT T-score, the better patient's functional capacity. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in a general population.

    The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.

    The change from baseline was analyzed with MMRM with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.

    Measured: MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported.

  3. Change From Screening Visit 1a in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score at Week 24

    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 mean a worse patient experience.

    The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.

    The change from baseline was analyzed with MMRM with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.

    Measured: MMRM included measurements at Visit 1a (Week -2/Week -1), Week 15, and Week 24. Change from Visit 1a values at Week 24 is reported.

  4. Change From Baseline in the T-score of the Number of Correct Responses on Tower of London at Week 26

    The Tower of London (ToL) evaluates executive functioning, reasoning, problem-solving, and goal-directed behavior. It measures the number of correct responses in solving an exercise that consists on moving colored balls to match a target configuration. The higher the ToL T-score, the better patient's cognitive function. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in a general population.

    The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.

    The change from baseline comparing the groups was analyzed using analysis of covariance (ANCOVA) model including treatment, stratification factor of screening MCCB overall composite T-score, and baseline number of correct responses on Tower of London T-score.

    Measured: At baseline and at Week 26.

  5. Ocular Safety Sub-study: Humphrey Visual Field 24-2 Swedish Interactive Thresholding Algorithm (SITA) Standard

    The Humphrey Visual Field 24-2 SITA Standard 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. The tests ranks from 0 to 100%, where 0 means no vision and 100 means perfect vision.

    Measured: At baseline and at Week 24.

  6. Ocular Safety Sub-study: Central Retinal Thickness as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT)

    The central retinal thickness for both eyes was measured by high-definition optical coherence tomography (spectral domain OCT), which evaluates the retinal and sub-retinal structures of both eyes.

    Measured: At baseline 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 posted15 Apr 2021
  2. Study start8 Sep 2021
  3. Primary completion17 Sep 2024
  4. Study completion1 Oct 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
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846868
Sponsor's protocol ID
1346-0011
Other IDs
2020-003760-11
Status last verified
Oct 2025
First submitted
13 Apr 2021
Last updated
5 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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 116 sites in 17 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 19 inclusion and 16 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 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in Japan, United States, China, Brazil, Greece and 12 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 5 Nov 2025). 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: MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported.). 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 NCT04846868, 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 5 Nov 2025.

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