AzTrials
AzTrials

SchizophreniaPhase 3NCT05211947

A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study

A Phase 3 study testing Iclepertin in people with Schizophrenia, run by Boehringer Ingelheim at 303 sites in 40 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term. Read more about this study

Who is it for?
Ages 18 to 51 years
Conditions the study is for
Schizophrenia
What is being tested?
Iclepertin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,356 participants
Where
303 sitesin 40 countries
Study dates
21 Mar 2022to 18 Mar 2025
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 51 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed and dated written informed consent.
  • Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)).
  • Patients, who completed participation in the parent trial.
  • 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

  • Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase III trial.
  • Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.
  • Positive urine drug screen ≥ 3 times during the treatment period of parent trial.
  • Patients who are currently or wish to participate in another investigational drug trial.
  • Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
  • Further exclusion criteria apply.

Trial locations and contacts

303 sites in 40 countries.

303 sites in 40 countries

Japan55 sites

  • Hotei Hospital

    Aichi, Konan, 483-8248

  • 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

  • Japan Institute for Health Security National Kohnodai Medical Center

    Chiba, Ichikawa, 272-8516

  • Uematsu Mental Clinic

    Fukuoka, Chikugo, 833-0041

  • Mental Clinic Sakurazaka

    Fukuoka, Fukuoka, 810-0023

  • AK Clinic

    Fukuoka, Fukuoka, 810-0031

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037

  • Hirota Clinic

    Fukuoka, Kurume, 830-0033

  • Shiranui Hospital

    Fukuoka, Omuta, 836-0004

  • Kishi Hospital

    Gumma, Kiryu, 376-0011

  • Obihiro-Kosei General Hospital

    Hokkaido, Obihiro, 080-0024

  • Hokudai-dori Mental Health Clinic

    Hokkaido, Sapporo, 001-0010

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Tatsuta Clinic

    Hyogo, Kobe, 651-0097

  • Kanazawa Medical University Hospital

    Ishikwa, Kahoku-gun, 920-0293

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014

  • St. Marianna University Hospital

    Kanagawa, Kawasaki, 216-8511

  • Links Mental Clinic

    Kanagawa, Yokohama, 224-0001

  • Yokohama Onoecho Clinic

    Kanagawa, Yokohama, 231-0015

  • Hino Hospital

    Kanagawa, Yokohama, 234-0051

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • Yuge Neuropsychiatric Hospital

    Kumamoto, Kumamoto, 861-8002

  • Medical Corporation Yamadakai Yatsushiro Welfare Hospital

    Kumamoto, Yatsushiro, 866-0043

  • National Hospital Organization Maizuru Medical Center

    Kyoto, Maizuru, 625-8502

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Shounan Hospital

    Nagano, Matsumoto, 390-0847

  • Suwa Red Cross Hospital

    Nagano, Suwa, 392-8510

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • University of the Ryukyus Hospital

    Okinawa, Ginowan, 901-2725

  • Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • National Hospital Organization Hizen Psychiatric Medical Center

    Saga, Kanzaki-gun, 842-0192

  • Rainbow and Sea Hospital

    Saga, Karatsu, 847-0031

  • Inuo Hospital

    Saga, Tosu, 841-0081

  • 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

  • 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

  • National Center of Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851

  • Asuka Hospital

    Tokyo, Machida, 194-0005

  • 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

  • Ohwa Mental Clinic

    Tokyo, Toshima-ku, 170-0002

  • Hokuriku Hospital

    Toyama, Nanto, 939-1893

  • Yamaguchi University Hospital

    Yamaguchi, Ube, 755-8505

  • University of Yamanashi Hospital

    Yamanashi, Chuo, 409-3898

Other trials in Japan

United States49 sites

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Synexus Clinical Research-Atlanta-67262

    Atlanta, Georgia, 30328

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • 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

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • ProScience Research Group

    Culver City, California, 90230

  • Relaro Medical Trials, LLC

    Dallas, Texas, 75243

  • Midwest Clinical Research

    Dayton, Ohio, 45417

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • University of Oregon Prevention Science Institute

    Eugene, Oregon, 97403

  • JPS Center for Behavioral Health Recovery

    Fort Worth, Texas, 76104

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Center for Behavioral Health, LLC

    Gaithersburg, Maryland, 20877

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Institute of Living

    Hartford, Connecticut, 06106

  • Advanced Medical Research Group Inc

    Hollywood, Florida, 33021

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Insight Clinical Trials, LLC, Independence

    Independence, Ohio, 44131

  • Omega Clinical Trials,LLC

    La Habra, California, 90631

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

    Long Beach, California, 90807

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Accel Research Sites Network

    Maitland, Florida, 32751

  • Hassman Research Institute-Marlton-66897

    Marlton, New Jersey, 08053

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33014

  • CCM Clinical Research Group, LLC-Miami-68482

    Miami, Florida, 33133

  • Optimus U Corporation-Miami-69452

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • Connecticut Mental Health Center

    New Haven, Connecticut, 06519

  • New York State Psychiatric Institute

    New York, New York, 10032

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • Omaha Insomnia and Psychiatric Services

    Omaha, Nebraska, 68144

  • ATP Clinical Research, Inc.

    Orange, California, 92866

  • NRC Research Institute

    Orange, California, 92868

  • 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

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California, 92704

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Arch Clinical Trials, LLC

    St Louis, Missouri, 63141

  • Stanford University Medical Center

    Stanford, California, 94304

  • Oasis Life Care

    State College, Pennsylvania, 16801

  • Richmond Behavioral Associates-Staten Island-68636

    Staten Island, New York, 10314

  • Collaborative Neuroscience Research

    Torrance, California, 90504

Other trials in United States

China23 sites

  • The sixth People's Hospital of Hebei Province

    Baoding, 71000

  • Beijing Anding Hospital

    Beijing, 100088

  • 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 Second Xiangya Hospital Of Central South University

    Changsha, 410011

  • The Affiliated Brain Hospital of Guangzhou Medical University

    Guangzhou, 510370

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • Huzhou Third Municipal Hospital

    Huzhou, 313000

  • Shandong Daizhuang Hospital

    Jining, 272051

  • The First Affilliated Hospital Of Kunming of Medical College

    Kunming, 650032

  • Nanjing Brain Hospital

    Nanjing, 210029

  • The Affilicated Kangning Hospital of Ningbo University

    Ningbo, 315201

  • Shanghai Mental Health Center

    Shanghai, 200030

  • Tongji Hospital, Tongji University

    Shanghai, 200065

  • Shenzhen Kangning Hospital

    Shenzhen, 518003

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050030

  • Tianjin Anding Hospital

    Tianjin, 300222

  • Wuxi mental health center

    Wuxi, 214151

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • Xi'an Mental Health Center

    Xi'an, 710101

  • The Second Affiliated Hospital of Xinxiang Medical Univ.

    Xinxiang, 453002

  • Zhumadian Psychiatric Hospital

    Zhumadian, 463000

Other trials in China

Argentina14 sites

  • Clínica Privada Banfield

    Banfield, B1828CKR

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

    CABA, 1058AAJ

  • 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

  • Sanatorio Morra S.A.

    Córdoba, X5009

  • Instituto de Neurociencias San Agustín

    La Plata, 1900

  • Global Psy Asociación Civil

    La Plata, CP B1904AXQ

  • Resolution Psychopharmacology Research Institute

    Mendoza, 5502

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, 2000

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, S2000QJI

  • Centro Medico Luquez

    San Vicente, X5006CBI

Other trials in Argentina

Mexico12 sites

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

    Culiacán, 80230

  • Clinica Cemelli

    Guadalajara, 44660

  • Hospital Aranda de la Parra

    León, 37000

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Centro de Investigación Clinica Acelerada, S.C.

    Mexico City, 07369

  • GabiPros S.C.

    Mexico City, 07810

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, 14269

  • Iecsi S.C.

    Monterrey, 64310

  • CIT-Neuropsique S.C

    Monterrey, 64610

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

    Monterrey, 64710

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

  • BIND Investigaciones S.C.

    San Luis Potosí City, 78213

Other trials in Mexico

Brazil11 sites

  • CPN - Centro de Estudos em Neurociências

    Belo Horizonte, 30150-270

  • 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

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

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

    São José do Rio Preto, 15090-000

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000

  • BR Trials

    São Paulo, 01236-030

  • Clínica Viver - Centro de Desospitalização Humana

    São Paulo, 04020-060

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, 05403-903

Other trials in Brazil

Spain10 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

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Centro de Salud de San Juan

    Salamanca, 37005

  • 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

Germany9 sites

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

    Bad Homburg, 61348

  • Praxis Dr. Hahn, Berlin

    Berlin, 13187

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, 71034

  • LWL-Klinik Dortmund

    Dortmund, 44287

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159

  • Klinikum der Universität München AÖR

    München, 80336

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Studienzentrum Nord-West

    Westerstede, 26655

Other trials in Germany

Poland9 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

  • Central Clinical Hospital of the Medical University of Lodz

    Lodz, 92-216

  • Individual Specialist Medical Practice Filip Rybakowski

    Poznan, 60-744

  • EUROMEDIS Sp. z o.o., Szczecin

    Szczecin, 70-111

  • Institute of Psychiatry and Neurology in Warsaw

    Warsaw, 02-957

  • Clinhouse

    Zabrze, 41-807

Other trials in Poland

France8 sites

  • HOP Charles Perrens

    Bordeaux, 33076

  • HOP la Colombière

    Montpellier, 34295

  • HOP Hôtel-Dieu

    Nantes, 44093

  • Hôpital 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

South Korea8 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Yeungnam University Medical Center

    Daegu, 42415

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Chonnam National University Hospital

    Gwangju, 61453

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Pusan National University Yangsan Hospital

    Yangsan, 626-770

Other trials in South Korea

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, 330

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

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

Czechia6 sites

  • National Institute of Mental Health

    Klecany, 25067

  • MP Meditrine s.r.o.

    Ostrava, 70800

  • 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

Serbia6 sites

  • Clinical Hospital Center Dr. Dragisa Misovic

    Belgrade, 11000

  • General Hospital Euromedik

    Belgrade, 11000

  • Institute for Mental Health

    Belgrade, 11000

  • Special Hospital for Psychiatric Diseases Gornja Toponica

    Gornja Toponica, 18202

  • Special Hospital for Psychiatric Diseases Sveti Vračevi

    Novi Kneževac, 23330

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

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

Croatia5 sites

  • Clincal Hospital Centre Rijeka

    Rijeka, 51 000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10 000

  • Solmed Polyclinic

    Zagreb, 1000

  • Psychiatric Hospital 'Sveti Ivan'

    Zagreb, 10090

  • University Psychiatric Hospital Vrapce

    Zagreb, 10090

Other trials in Croatia

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

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)

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

Malaysia4 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Sentosa

    Kuching, 93250

  • Hospital Tuanku Ja'afar

    Seremban, 70300

Other trials in Malaysia

Denmark3 sites

  • Aalborg Universitetsshospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Psykiatrisk Center Glostrup

    Glostrup Municipality, 2600

Other trials in Denmark

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

Bulgaria2 sites

  • Medical Center "Spectar"

    Plovdiv, 4000

  • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry

    Plovdiv, 4002

Other trials in Bulgaria

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M5T 1R8

Other trials in Canada

Chile2 sites

  • Biomedica Research Group

    Santiago, 7500710

  • Psicomed Estudios Clínicos

    Segunda Región, 1270244

Other trials in Chile

Finland2 sites

  • Aurora hospital

    Helsinki, 00250

  • CRST - Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

Norway2 sites

  • Sykehuset Østfold HF, avd. Moss

    Moss, N-1535

  • Akershus universitetssykehus Oslo

    Oslo, 0963

Other trials in Norway

Romania2 sites

  • Mental Health Center Sector 4

    Bucharest, 040872

  • SC Carpe Diem SRL

    Sibiu, 557260

Other trials in Romania

Sweden2 sites

  • Psykiatriska Kliniken

    Helsingborg, 20153

  • Akademiska sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Australia1 site

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

Other trials in Australia

Austria1 site

  • AKH - Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Hungary1 site

  • Semmelweis University

    Budapest, 1082

Other trials in Hungary

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 AV

Other trials in Netherlands

New Zealand1 site

  • North Shore Hospital

    Takpuna Auckland, 0622

Other trials in New Zealand

Philippines1 site

  • Philippine General Hospital

    Manila, Philippines, 1000

Other trials in Philippines

Portugal1 site

  • ULS da Região de Leiria, E.P.E.

    Leiria, 2410-197

Other trials in Portugal

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About this study

Official title: An Open Label, Single Arm, Extension Trial to Examine Long-term Safety of Iclepertin Once Daily in Patients With Schizophrenia Who Have Completed Previous Iclepertin Phase III Trials (CONNEX-X)

This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.

Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.

Read more

Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.

The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.

Conditions
Schizophrenia
Being tested
Iclepertin
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 10 milligram (mg) tablet once daily.

Study groups in NCT05211947
Study groupRoleWhat they receive
Iclepertin 10 mgExperimentalParticipants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
Receives: Drug: Iclepertin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of Treatment Emergent Adverse Events (TEAEs)

    Number of participants with treatment emergent adverse events.

    Measured: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.

Secondary outcomes (2)

  1. Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)

    The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as [CGI-S EOT] - [CGI-S baseline] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.

    Measured: At baseline and at EOT. Up to a maximum of 60.1 weeks.

  2. Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)

    Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as [last Hb on treatment] - [Hb baseline], is reported.

    Measured: At baseline and at EOT. Up to a maximum of 60.1 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start21 Mar 2022
  3. Primary completion26 Feb 2025
  4. Study completion18 Mar 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211947
Sponsor's protocol ID
1346-0014
Other IDs
2020-003745-11
Status last verified
Mar 2026
First submitted
14 Jan 2022
Last updated
8 Apr 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.clinicalstudies.boehringer-ingelheim.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.

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 303 sites in 40 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 303 sites in Japan, United States, China, Argentina, Mexico and 35 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. 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 8 Apr 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?

Occurence of Treatment Emergent Adverse Events (TEAEs) (time frame: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.). 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 NCT05211947.

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 8 Apr 2026.

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