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SchizophreniaPhase 3NCT04846881

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

A Phase 3 study testing Iclepertin in people with Schizophrenia, run by Boehringer Ingelheim at 127 sites in 18 countries.

Completed

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

Official record
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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
611 participants
Where
127 sitesin 18 countries
Study dates
24 Aug 2021to 17 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

  • 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.
  • 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 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.
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  • 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.
  • 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 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Cognitive impairment due to developmental, neurological (e.g. stroke) or other disorders including head trauma, or patients with dementia or epilepsy.
  • 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).
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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 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.
  • 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

127 sites in 18 countries.

127 sites in 18 countries

Japan29 sites

  • Okehazama Hospital Fujita Kokoro Care Center

    Aichi, Toyoake, 470-1168

  • Toyota Memorial Hospital

    Aichi, Toyota, 471-8513

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    Chiba, Chiba, 266-0007

  • Uematsu Mental Clinic

    Fukuoka, Chikugo, 833-0041

  • AK Clinic

    Fukuoka, Fukuoka, 810-0031

  • Hirota Clinic

    Fukuoka, Kurume, 830-0033

  • Kishi Hospital

    Gumma, Kiryu, 376-0011

  • Hokudai-dori Mental Health Clinic

    Hokkaido, Sapporo, 001-0010

  • Tatsuta Clinic

    Hyogo, Kobe, 651-0097

  • Kanazawa Medical University Hospital

    Ishikwa, Kahoku-gun, 920-0293

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014

  • Links Mental Clinic

    Kanagawa, Yokohama, 224-0001

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004

  • Yuge Neuropsychiatric Hospital

    Kumamoto, Kumamoto, 861-8002

  • Medical Corporation Yamadakai Yatsushiro Welfare Hospital

    Kumamoto, Yatsushiro, 866-0043

  • Suwa Red Cross Hospital

    Nagano, Suwa, 392-8510

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • University of the Ryukyus Hospital

    Okinawa, Ginowan, 901-2725

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Rainbow and Sea Hospital

    Saga, Karatsu, 847-0031

  • Inuo Hospital

    Saga, Tosu, 841-0081

  • Medical Corporation Seijin Hospital

    Tokyo, Adachi-ku, 121-8515

  • Institute of Science Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8519

  • Nishigahara Hospital

    Tokyo, Kita-ku, 114-0024

  • Minami-Aoyama Antique Street Clinic

    Tokyo, Minato-ku, 107-0062

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541

  • Maynds Tower Mental Clinic

    Tokyo, Shibuya-ku, 151-0053

  • Shinjuku East Mental Clinic

    Tokyo, Shinjuku-ku, 160-0021

  • Hokuriku Hospital

    Toyama, Nanto, 939-1893

Other trials in Japan

United States20 sites

  • Sheppard Pratt Physicians's Practice Association, Inc.

    Baltimore, Maryland, 21204

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Clinical Innovations, Inc

    Bellflower, California, 90706

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • American Medical Research

    Chicago, Illinois, 60612

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Relaro Medical Trials, LLC

    Dallas, Texas, 75243

  • John Peter Smith Health Network

    Fort Worth, Texas, 76104

  • Research in Miami Inc

    Hialeah, Florida, 33013

  • Insight Clinical Trials, LLC, Independence

    Independence, Ohio, 44131

  • ASCLEPES Research Centers, P.C. dba Alliance Research

    Long Beach, California, 90807

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Optimus U Corporation-Miami-69452

    Miami, Florida, 33135

  • Connecticut Mental Health Center

    New Haven, Connecticut, 06519

  • New York State Psychiatric Institute

    New York, New York, 10032

  • NRC Research Institute

    Orange, California, 92868

  • Salem VA Medical Center

    Salem, Virginia, 24153

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Collaborative Neuroscience Research, LLC-Torrance-69527

    Torrance, California, 90504

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407

Other trials in United States

Spain13 sites

  • Hestia Palau

    Barcelona, 08025

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario General de Villalba

    Collado de Villalba, 28400

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Centro de Salud mental de Getafe

    Getafe, 28903

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital de Son Llàtzer

    Palma, 07198

  • Centro de Salud de San Juan

    Salamanca, 37005

  • Benito Menni Complejo Asistencial en Salud Mental

    Sant Boi de Llobregat, 08830

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010

  • Hospital Nicolás Peña

    Vigo, 36211

  • Hospital Provincial. Complejo Asistencial de Zamora

    Zamora, 49021

Other trials in Spain

France12 sites

  • HOP Charles Perrens

    Bordeaux, 33076

  • HOP Gabriel-Montpied

    Clermont-Ferrand, 63003

  • HOP Albert Chenevier

    Créteil, 94000

  • HOP André Mignot

    Le Chesnay-Rocquencourt, 78150

  • HOP Fontan

    Lille, 59037

  • HOP la Colombière

    Montpellier, 34295

  • HOP Hôtel-Dieu

    Nantes, 44093

  • HOP Pasteur

    Nice, 06000

  • HOP Carémeau

    Nîmes, 30029

  • HOP Guillaume Régnier

    Rennes, 35703

  • HOP Rouffach

    Rouffach, 68250

  • HOP Nord-Saint-Priest-en-Jarez-53664

    Saint-Priest-en-Jarez, 42270

Other trials in France

Argentina8 sites

  • CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)

    CABA, 1058AAJ

  • SERES Neurociencia Cognitiva Aplicada

    CABA, 1111

  • Fundación FunDaMos para la asistencia e investigación en psiquiatría

    CABA, C1405BOA

  • CEN (Centro Especializado Neurociencias)

    Córdoba, 5004

  • Sanatorio Morra S.A.

    Córdoba, X5009

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata, 1900

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, S2000QJI

Other trials in Argentina

Poland7 sites

  • Psychiatric Doctor's Office Ireneusz Kaczorowski

    Bełchatów, 97-400

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756

  • Health Center Alcea

    Gdansk, 80-283

  • MentalMEDIC

    Gliwice, 44100

  • Provincial Hospital for Nervous and Mentally Ill in Swiecie

    Gmina Świecie, 86-100

  • EUROMEDIS Sp. z o.o., Szczecin

    Szczecin, 70-111

  • Clinhouse

    Zabrze, 41-807

Other trials in Poland

Brazil5 sites

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09715-090

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000

  • Clínica Viver - Centro de Desospitalização Humana

    São Paulo, 04020-060

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-010

Other trials in Brazil

Croatia5 sites

  • Clincal Hospital Centre Rijeka

    Rijeka, 51 000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10 000

  • Solmed Polyclinic

    Zagreb, 10000

  • Psychiatric Hospital 'Sveti Ivan'

    Zagreb, 10090

  • University Psychiatric Hospital Vrapce

    Zagreb, 10090

Other trials in Croatia

South Korea5 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Inha University Hospital

    Incheon, 400 711

  • Chonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

Hungary4 sites

  • Obudai Egeszegugyi Centrum Kft.

    Budapest, 1036

  • Semmelweis University

    Budapest, 1082

  • University of Debrecen, Gyula Kenezi University Hospital

    Debrecen, 4031

  • PsychoTech Ltd.

    Pécs, 7633

Other trials in Hungary

Malaysia4 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Sentosa

    Kuching, 93250

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Serbia3 sites

  • Institute for Mental Health

    Belgrade, 11000

  • Special Hospital for Psychiatric Diseases Sveti Vračevi

    Novi Kneževac, 23330

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Slovakia3 sites

  • Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201

  • EPAMED s.r.o.

    Košice, 040 01

  • Psychiatricka Ambulancia Psycholine s.r.o.

    Rimavská Sobota, 97901

Other trials in Slovakia

Chile2 sites

  • Biomedica Research Group

    Santiago, 7500710

  • Psicomed Estudios Clínicos

    Segunda Región, 1270244

Other trials in Chile

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 AV

  • Maastricht University

    Maastricht, 6229 HX

Other trials in Netherlands

Romania2 sites

  • Mental Health Center Sector 4

    Bucharest, 040872

  • SC Carpe Diem SRL

    Sibiu, 557260

Other trials in Romania

Singapore2 sites

  • Changi General Hospital

    Singapore, 529889

  • Institute of Mental Health

    Singapore, 539747

Other trials in Singapore

Ukraine1 site

  • Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

    Nove, 25491

Other trials in Ukraine

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-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.

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. 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.

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 iclepertin taken once daily for 26 weeks

  • PlaceboDrug

    One tablet of matching placebo taken once daily for 26 weeks

Study groups in NCT04846881
Study groupRoleWhat they receive
Iclepertin 10 mgExperimentalThis 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.
Receives: Drug: Iclepertin
PlaceboPlacebo comparatorThis 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.
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 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.

    Measured: 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 outcomes (4)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: Baseline and at Week 26

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 start24 Aug 2021
  3. Primary completion18 Oct 2024
  4. Study completion17 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
611 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846881
Sponsor's protocol ID
1346-0012
Other IDs
2020-003744-84
Status last verified
Nov 2025
First submitted
13 Apr 2021
Last updated
12 Dec 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 127 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 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Japan, United States, Spain, France, Argentina 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 12 Dec 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 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 (time frame: 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.). 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 NCT04846881, 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 12 Dec 2025.

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