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

March 30, 2026 updated by: Boehringer Ingelheim

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Banfield, Argentina, B1828CKR
        • Clinica Privada Banfield
      • CABA, Argentina, 1058AAJ
        • CENYDET-Centro Neurobiologico y de Estres Traumatico (Biopsychomedical Research Group S.R.L.)
      • CABA, Argentina, C1405BOA
        • Fundación FunDaMos para la asistencia e investigación en psiquiatría
      • CABA, Argentina, C1133AAH
        • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
      • Córdoba, Argentina, X5000FAL
        • Instituto Modelo de Neurología Lennox
      • Córdoba, Argentina, X5009
        • Sanatorio Morra S.A.
      • Córdoba, Argentina, 5004
        • CEN (Centro Especializado Neurociencias)
      • Córdoba, Argentina, X5003DCE
        • Instituto Medico DAMIC S.R.L.
      • La Plata, Argentina, 1900
        • Instituto de Neurociencias San Agustín
      • La Plata, Argentina, CP B1904AXQ
        • Global Psy Asociación Civil
      • Mendoza, Argentina, 5502
        • Resolution Psychopharmacology Research Institute
      • Rosario, Argentina, 2000
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario, Argentina, S2000QJI
        • Centro de Investigación y Asistencia en Psiquiatría (CIAP)
      • San Vicente, Argentina, X5006CBI
        • Centro Médico Luquez
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Monash Alfred Psychiatry Research Centre
  • Austria
      • Vienna, Austria, 1090
        • AKH - Medical University of Vienna
  • Belgium
      • Bertix, Belgium, 6880
        • CUP Vivalia -La Clairière
      • Bierbeek, Belgium, 3360
        • Sint-Kamillus
      • Duffel, Belgium, 2570
        • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
      • Mechelen, Belgium, 2800
        • Meclinas
  • Brazil
      • Belo Horizonte, Brazil, 30150-270
        • CPN - Centro de Estudos em Neurociências
      • Criciúma, Brazil, 88811-000
        • Hospital São José
      • Curitiba, Brazil, 80.240-280
        • Trial Tech- Tecnologia em pesquisa com medicamentos
      • Goiânia, Brazil, 74093-040
        • J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria
      • Rio de Janeiro, Brazil, 22270-060
        • Ruschel Medicina e Pesquisa Clínica
      • São Bernardo do Campo, Brazil, 09780-000
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São José do Rio Preto, Brazil, 15090-000
        • Hospital de Base - Fac Med de Sao Jose do Rio Preto
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clinica Ltda
      • São Paulo, Brazil, 05403-903
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
      • São Paulo, Brazil, 01236-030
        • BR Trials
      • São Paulo, Brazil, 04020-060
        • Clinica Viver - Centro de Desospitalizacao Humana
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Medical Center "Spectar"
      • Plovdiv, Bulgaria, 4002
        • Filipopolis Ambulatory for Group Practice for Specialized Care in Psychiatry
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health (CAMH)
  • Chile
      • Santiago, Chile, 7500710
        • BioMedica Research Group
      • Segunda Región, Chile, 1270244
        • Psicomed Estudios Clínicos
  • China
      • Baoding, China, 71000
        • The sixth People's Hospital of Hebei Province
      • Beijing, China, 100096
        • Beijing Huilongguan Hospital
      • Beijing, China, 100088
        • Beijing Anding Hospital
      • Beijing, China, 100089
        • Peking University Sixth Hospital
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Changsha, China, 410007
        • The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province)
      • Guangzhou, China, 510630
        • The third affiliated hospital of Sun Yat-Sen University
      • Guangzhou, China, 510370
        • The Affiliated Brain Hospital of Guangzhou Medical University
      • Huzhou, China, 313000
        • Huzhou Third Municipal Hospital
      • Jining, China, 272051
        • Shandong Daizhuang Hospital
      • Kunming, China, 650032
        • The First Affilliated Hospital Of Kunming of Medical College
      • Nanjing, China, 210029
        • Nanjing Brain Hospital
      • Ningbo, China, 315201
        • The Affilicated Kangning Hospital of Ningbo University
      • Shanghai, China, 200065
        • Tongji Hospital, Tongji University
      • Shanghai, China, 200030
        • Shanghai Mental Health Center
      • Shenzhen, China, 518003
        • Shenzhen Kangning Hospital
      • Shijiazhuang, China, 050030
        • The First Hospital of Hebei Medical University
      • Tianjin, China, 300222
        • Tianjin Anding Hospital
      • Wuxi, China, 214151
        • Wuxi Mental Health Center
      • Xi'an, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
      • Xi'an, China, 710101
        • Xi'an Mental Health Center
      • Xinxiang, China, 453002
        • The Second Affiliated Hospital of Xinxiang Medical Univ.
      • Zhumadian, China, 463000
        • Zhumadian Psychiatric Hospital
  • Colombia
      • Barranquilla, Colombia, 80020
        • Centro de Investigación y Proyectos en neurociencia CIPNA
      • Bello, Colombia, 51053
        • E.S.E Hospital Mental de Antioquia
      • Bogotá, Colombia, 111166
        • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS
      • Bogotá, Colombia, 110121
        • Instituto Colombiano del Sistema Nervioso- Clínica Montserrat
      • Pereira, Colombia, 660003
        • Psynapsis Salud Mental S.A.
  • Croatia
      • Rijeka, Croatia, 51 000
        • Clincal Hospital Centre Rijeka
      • Zagreb, Croatia, 10 000
        • Clinical Hospital Centre Zagreb
      • Zagreb, Croatia, 10090
        • University Psychiatric Hospital Vrapce
      • Zagreb, Croatia, 10090
        • Psychiatric Hospital 'Sveti Ivan'
      • Zagreb, Croatia, 1000
        • Solmed Polyclinic
  • Czechia
      • Klecany, Czechia, 25067
        • National Institute of Mental Health
      • Ostrava, Czechia, 70800
        • MP Meditrine s.r.o.
      • Pilsen, Czechia, 30100
        • A-SHINE s.r.o
      • Prague, Czechia, 18600
        • INEP medical s.r.o.
      • Prague, Czechia, 120 00
        • PRAGTIS s.r.o.
      • Říčany, Czechia, 251 01
        • Psychiatrie Ricany s.r.o.
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetsshospital
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Glostrup Municipality, Denmark, 2600
        • Psykiatrisk Center Glostrup
  • Finland
      • Helsinki, Finland, 00250
        • Aurora hospital
      • Turku, Finland, 20520
        • CRST - Clinical Research Services Turku
  • France
      • Bordeaux, France, 33076
        • HOP Charles Perrens
      • Montpellier, France, 34295
        • HOP la Colombière
      • Nantes, France, 44093
        • HOP Hôtel-Dieu
      • Nice, France, 06000
        • Hôpital Pasteur
      • Nîmes, France, 30029
        • HOP Carémeau
      • Rennes, France, 35703
        • HOP Guillaume Régnier
      • Rouffach, France, 68250
        • HOP Rouffach
      • Saint-Priest-en-Jarez, France, 42270
        • HOP Nord-Saint-Priest-en-Jarez-53664
  • Germany
      • Bad Homburg, Germany, 61348
        • Zentrum für klinische Forschung Dr. med. I. Schöll GmbH
      • Berlin, Germany, 13187
        • Praxis Dr. Hahn, Berlin
      • Böblingen, Germany, 71034
        • Studienzentrum für Neurologie und Psychiatrie
      • Dortmund, Germany, 44287
        • LWL-Klinik Dortmund
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68159
        • Zentralinstitut für Seelische Gesundheit
      • München, Germany, 80336
        • Klinikum der Universität München AÖR
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
      • Westerstede, Germany, 26655
        • Studienzentrum Nord-West
  • Greece
      • Athens, Greece, 11528
        • Eginition Hospital
      • Chaïdári, Greece, 12462
        • "Attikon" University General Hospital of Attica
      • Haidari, Greece, 12462
        • Psychiatric Hospital of Attica
      • Heraklion, Greece, 71305
        • AX Mental Health Clinic
      • Nea Kifissia, Greece, 14564
        • General Oncology Hospital "Agioi Anargyri"
      • Thessaloniki, Greece, 54636
        • University General Hospital of Thessaloniki AHEPA
      • Thessaloniki, Greece, 57 010
        • General Hospital of Thessaloniki "G. Papanikolaou"
  • Hungary
      • Budapest, Hungary, 1082
        • Semmelweis University
  • Italy
      • Brescia, Italy, 25123
        • ASST degli Spedali Civili di Brescia
      • Milan, Italy, 20121
        • A.O. Fatebenefratelli
      • Milan, Italy, 20127
        • Ist. San Raffaele Turro
      • Orbassano (TO), Italy, 10043
        • Azienda Sanitaria Ospedale S. Luigi Gonzaga
      • Siena, Italy, 53100
        • A.O.U. Senese
  • Japan
      • Aichi, Konan, Japan, 483-8248
        • Hotei Hospital
      • Aichi, Toyoake, Japan, 470-1168
        • Okehazama Hospital Fujita Kokoro Care Center
      • Aichi, Toyota, Japan, 471-8513
        • Toyota Memorial Hospital
      • Chiba, Chiba, Japan, 266-0007
        • National Hospital Organization Shimofusa Psychiatric Medical Center
      • Chiba, Ichikawa, Japan, 272-8516
        • Japan Institute for Health Security National Kohnodai Medical Center
      • Fukuoka, Chikugo, Japan, 833-0041
        • Uematsu Mental Clinic
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Fukuoka, Japan, 819-0037
        • Kuramitsu Hospital
      • Fukuoka, Fukuoka, Japan, 810-0023
        • Mental Clinic Sakurazaka
      • Fukuoka, Fukuoka, Japan, 810-0031
        • AK Clinic
      • Fukuoka, Kurume, Japan, 830-0033
        • Hirota Clinic
      • Fukuoka, Omuta, Japan, 836-0004
        • Shiranui Hospital
      • Gumma, Kiryu, Japan, 376-0011
        • Kishi Hospital
      • Hokkaido, Obihiro, Japan, 080-0024
        • Obihiro-Kosei General Hospital
      • Hokkaido, Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Hokkaido, Sapporo, Japan, 001-0010
        • Hokudai-dori Mental Health Clinic
      • Hyogo, Kobe, Japan, 651-0097
        • Tatsuta Clinic
      • Ishikwa, Kahoku-gun, Japan, 920-0293
        • Kanazawa Medical University Hospital
      • Kanagawa, Kawasaki, Japan, 214-0014
        • Kishiro Mental Clinic
      • Kanagawa, Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
      • Kanagawa, Yokohama, Japan, 236-0004
        • Yokohama City University Hospital
      • Kanagawa, Yokohama, Japan, 231-0015
        • Yokohama Onoecho Clinic
      • Kanagawa, Yokohama, Japan, 234-0051
        • Hino Hospital
      • Kanagawa, Yokohama, Japan, 224-0001
        • Links Mental Clinic
      • Kochi, Kochi, Japan, 781-8555
        • Kochi Health Sciences Center
      • Kumamoto, Kumamoto, Japan, 861-8002
        • Yuge Neuropsychiatric Hospital
      • Kumamoto, Yatsushiro, Japan, 866-0043
        • Medical Corporation Yamadakai Yatsushiro Welfare Hospital
      • Kyoto, Maizuru, Japan, 625-8502
        • National Hospital Organization Maizuru Medical Center
      • Miyagi, Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Nagano, Matsumoto, Japan, 390-0847
        • Shounan Hospital
      • Nagano, Suwa, Japan, 392-8510
        • Suwa Red Cross Hospital
      • Nara, Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
      • Okinawa, Ginowan, Japan, 901-2725
        • University of the Ryukyus hospital
      • Osaka, Osaka, Japan, 534-0021
        • Osaka City Hospital Organization Osaka City General Hospital
      • Saga, Kanzaki-gun, Japan, 842-0192
        • National Hospital Organization Hizen Psychiatric Medical Center
      • Saga, Karatsu, Japan, 847-0031
        • Rainbow and Sea Hospital
      • Saga, Tosu, Japan, 841-0081
        • Inuo Hospital
      • Saitama, Kumagaya, Japan, 360-0816
        • Nishi Kumagaya Hospital
      • Saitama, Saitama, Japan, 336-0022
        • Sho Midori Hospital
      • Tochigi, Shimotsuga-gun, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Adachi-ku, Japan, 121-8515
        • Medical Corporation Seijin Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Institute of Science Tokyo Hospital
      • Tokyo, Kita-ku, Japan, 114-0024
        • Nishigahara Hospital
      • Tokyo, Kodaira, Japan, 187-8851
        • National Center of Neurology and Psychiatry
      • Tokyo, Machida, Japan, 194-0005
        • Asuka Hospital
      • Tokyo, Minato-ku, Japan, 107-0062
        • Minami-Aoyama Antique Street Clinic
      • Tokyo, Ota-ku, Japan, 143-8541
        • Toho University Omori Medical Center
      • Tokyo, Shibuya-ku, Japan, 151-0053
        • Maynds Tower Mental Clinic
      • Tokyo, Shinjuku-ku, Japan, 160-0021
        • Shinjuku East Mental Clinic
      • Tokyo, Toshima-ku, Japan, 170-0002
        • Ohwa Mental Clinic
      • Toyama, Nanto, Japan, 939-1893
        • Hokuriku Hospital
      • Yamaguchi, Ube, Japan, 755-8505
        • Yamaguchi University Hospital
      • Yamanashi, Chuo, Japan, 409-3898
        • University of Yamanashi Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-44279
        • JSC Romuvos Clinic
      • Kaunas, Lithuania, LT-53137
        • LUHS KH Psichiatric Clinic Mariu Division
      • Vilnius, Lithuania, LT-10309
        • Vilnius City Mental Health Center
      • Šilutė, Lithuania, LT-99142
        • JSC Medical center "Puriena"
  • Malaysia
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuching, Malaysia, 93250
        • Hospital Sentosa
      • Seremban, Malaysia, 70300
        • Hospital Tuanku Ja'afar
  • Mexico
      • Culiacán, Mexico, 80230
        • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
      • Guadalajara, Mexico, 44660
        • Clinica Cemelli
      • León, Mexico, 37000
        • Hospital Aranda de La Parra
      • Mexico City, Mexico, 14269
        • Instituto Nacional de Neurologia y Neurocirugia
      • Mexico City, Mexico, 07369
        • Centro de Investigación Clinica Acelerada, S.C.
      • Mexico City, Mexico, 07810
        • GabiPros S.C.
      • Monterrey, Mexico, 64610
        • CIT-Neuropsique S.C
      • Monterrey, Mexico, 64310
        • Iecsi S.C.
      • Monterrey, Mexico, 64710
        • Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).
      • Mérida, Mexico, 97070
        • Medical Care & Research SA de CV
      • Nuevo León, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • San Luis Potosí City, Mexico, 78213
        • BIND Investigaciones S.C.
  • Netherlands
      • Groningen, Netherlands, 9713 AV
        • Universitair Medisch Centrum Groningen
  • New Zealand
      • Takpuna Auckland, New Zealand, 0622
        • North Shore Hospital
  • Norway
      • Moss, Norway, N-1535
        • Sykehuset Østfold HF, avd. Moss
      • Oslo, Norway, 0963
        • Akershus universitetssykehus Oslo
  • Philippines
      • Manila, Philippines, Philippines, 1000
        • Philippine General Hospital
  • Poland
      • Bełchatów, Poland, 97-400
        • Psychiatric Doctor's Office Ireneusz Kaczorowski
      • Bialystok, Poland, 15-756
        • Podlassian Center of Psychogeriatry, Bialystok
      • Gdansk, Poland, 80-283
        • Health Center Alcea
      • Gliwice, Poland, 44100
        • MentalMEDIC
      • Lodz, Poland, 92-216
        • Central Clinical Hospital of the Medical University of Lodz
      • Poznan, Poland, 60-744
        • Individual Specialist Medical Practice Filip Rybakowski
      • Szczecin, Poland, 70-111
        • EUROMEDIS Sp. z o.o., Szczecin
      • Warsaw, Poland, 02-957
        • Institute of Psychiatry and Neurology in Warsaw
      • Zabrze, Poland, 41-807
        • Clinhouse
  • Portugal
      • Leiria, Portugal, 2410-197
        • ULS da Região de Leiria, E.P.E.
  • Romania
      • Bucharest, Romania, 040872
        • Mental Health Center Sector 4
      • Sibiu, Romania, 557260
        • SC Carpe Diem SRL
  • Serbia
      • Belgrade, Serbia, 11000
        • General Hospital Euromedik
      • Belgrade, Serbia, 11000
        • Institute for Mental Health
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Dr. Dragisa Misovic
      • Gornja Toponica, Serbia, 18202
        • Special Hospital for Psychiatric Diseases Gornja Toponica
      • Novi Kneževac, Serbia, 23330
        • Special Hospital for Psychiatric Diseases Sveti Vracevi
      • Novi Sad, Serbia, 21000
        • Clinical Center of Vojvodina
  • Slovakia
      • Bojnice, Slovakia, 97201
        • Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
      • Košice, Slovakia, 040 01
        • EPAMED s.r.o.
      • Rimavská Sobota, Slovakia, 97901
        • Psychiatricka Ambulancia Psycholine S.R.O.
  • South Korea
      • Busan, South Korea, 47392
        • Inje University Busan Paik Hospital
      • Daegu, South Korea, 42472
        • Daegu Catholic University Medical Center
      • Daegu, South Korea, 42415
        • Yeungnam University Medical Center
      • Gwangju, South Korea, 61453
        • Chonnam National University Hospital
      • Incheon, South Korea, 22332
        • Inha University Hospital
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Yangsan, South Korea, 626-770
        • Pusan National University Yangsan Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08025
        • Hestia Palau
      • Collado de Villalba, Spain, 28400
        • Hospital Universitario General de Villalba
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Majadahonda, Spain, 28222
        • Hospital Puerta de Hierro
      • Salamanca, Spain, 37005
        • Centro de Salud de San Juan
      • Seville, Spain, 41013
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spain, 36211
        • Hospital Nicolás Peña
      • Zamora, Spain, 49021
        • Hospital Provincial. Complejo Asistencial de Zamora
  • Sweden
      • Helsingborg, Sweden, 20153
        • Psykiatriska Kliniken
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset
  • Taiwan
      • Kaohsiung City, Taiwan, 802
        • Kai-Syuan Psychiatric Hospital
      • Keelung, Taiwan, 204
        • Chang Gung Memorial Hospital-Keelung
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • NCKUH
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 330
        • Chang Gung Memorial Hospital, Linkou
      • Taoyuan District, Taiwan, 33058
        • Taoyuan Psychiatric Center
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Turkey (Türkiye), 06590
        • Ankara University Medical School
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul University
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylul Universitesi Psikiyatri A.B.D.
      • Manisa, Turkey (Türkiye), 45030
        • Celal Bayar Universitesi Tip Fakultesi
  • Ukraine
      • Nove, Ukraine, 25491
        • Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council
  • United Kingdom
      • Bodmin, United Kingdom, PL31 2QT
        • Bodmin Community Hospital
      • Cheltenham, United Kingdom, GL53 9DZ
        • The Fritchie Centre
      • Chester, United Kingdom, CH2 1BQ
        • Redesmere
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • London, United Kingdom, SE5 8AZ
        • Maudsley Hospital
      • Oxford, United Kingdom, OX3 7JX
        • Warneford Hospital
      • Southampton, United Kingdom, SO30 3JB
        • Moorgreen Hospital
  • United States
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • Clinical Innovations, Inc
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, LLC (CNS)
      • La Habra, California, United States, 90631
        • Omega Clinical Trials,LLC
      • Long Beach, California, United States, 90807
        • Asclepes Research Centers, P.C. Dba Alliance Research
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Orange, California, United States, 92866
        • ATP Clinical Research, Inc.
      • Pico Rivera, California, United States, 90660
        • CNRI - Los Angeles
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research, LLC
      • Santa Ana, California, United States, 92704
        • Velocity Clinical Research, Santa Ana
      • Stanford, California, United States, 94304
        • Stanford University Medical Center
      • Torrance, California, United States, 90504
        • Collaborative Neuroscience Research
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Institute of Living
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Advanced Medical Research Group Inc
      • Maitland, Florida, United States, 32751
        • Accel Research Sites Network
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33014
        • San Marcus Research Clinic, Inc.
      • Miami, Florida, United States, 33135
        • Optimus U Corporation-Miami-69452
      • Miami, Florida, United States, 33133
        • CCM Clinical Research Group, LLC-Miami-68482
      • Orlando, Florida, United States, 32803
        • Nova Psychiatry Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research-Atlanta-67262
    • Illinois
      • Chicago, Illinois, United States, 60612
        • American Medical Research
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Sheppard Pratt Physicians's Practice Association, Inc.
      • Gaithersburg, Maryland, United States, 20877
        • Center for Behavioral Health, LLC
    • Missouri
      • St Louis, Missouri, United States, 63128
        • PsychCare Consultants Research
      • St Louis, Missouri, United States, 63141
        • Arch Clinical Trials, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Omaha Insomnia and Psychiatric Services
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute-Marlton-66897
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
      • Staten Island, New York, United States, 10314
        • Richmond Behavioral Associates-Staten Island-68636
    • North Carolina
      • Raleigh, North Carolina, United States, 27608
        • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research
      • Independence, Ohio, United States, 44131
        • Insight Clinical Trials, LLC, Independence
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research, PLLC
    • Oregon
      • Eugene, Oregon, United States, 97403
        • University of Oregon Prevention Science Institute
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Oasis Life Care
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials, LLC
      • DeSoto, Texas, United States, 75115
        • Insite clinical research
      • Fort Worth, Texas, United States, 76104
        • North Texas Clinical Trials
      • Fort Worth, Texas, United States, 76104
        • JPS Center for Behavioral Health Recovery
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Richmond, Texas, United States, 77407
        • LinQ Research, LLC-Richmond-70076
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iclepertin 10 mg
Participants 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.
Drug: Iclepertin
One 10 milligram (mg) tablet once daily.
Other Names:
  • BI 425809

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Number of participants with treatment emergent adverse events.
From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
Time Frame: At baseline and at EOT. Up to a maximum of 60.1 weeks.
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.
At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
Time Frame: At baseline and at EOT. Up to a maximum of 60.1 weeks.
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as [last Hb on treatment] - [Hb baseline], is reported.
At baseline and at EOT. Up to a maximum of 60.1 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

February 26, 2025

Study Completion (Actual)

March 18, 2025

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1346-0014
  • 2020-003745-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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