Clinical trial • Phase II • Gastroenterology
Obefazimod for Moderate to severe ulcerative colitis
Phase II trial of Obefazimod for Moderate to severe ulcerative colitis. open-label. 42 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Moderate to severe ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-05-2024
- First CTIS Authorization Date
- 11-06-2024
Trial design
open-label Phase II trial in Spain, Slovenia, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 42
Eligibility
Recruits 42 The record indicates a vulnerable population selection. Participants must "understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures". No specific assent procedures for minors are described in the available criteria; consent is to be provided by the participant. Additional requirements for women of childbearing potential (monthly urine pregnancy tests, contraception requirements) are specified..
- Pregnancy Exclusion
- Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test.
- Vulnerable Population
- The record indicates a vulnerable population selection. Participants must "understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures". No specific assent procedures for minors are described in the available criteria; consent is to be provided by the participant. Additional requirements for women of childbearing potential (monthly urine pregnancy tests, contraception requirements) are specified.
Inclusion criteria
- {"criterion_text":"- Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies"}
- {"criterion_text":"- Subjects should be in endoscopic improvement with a rectal bleeding sub-score = 0 point at the end of treatment period in the previous study (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of ≤1 with a rectal bleeding sub-score = 0 point"}
- {"criterion_text":"- Subjects able and willing to comply with study visits and procedures"}
- {"criterion_text":"- Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures"}
- {"criterion_text":"- Women of childbearing potential and men receiving the study treatment and their partners must agree to use highly effective contraceptive method during the study and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. The WOCBP must be willing to perform once a month a urine pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male subjects must not be planning pregnancy during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). In addition, male subjects should use condom during the trial and for at least 4-week follow-up (i.e. 4 weeks after last IMP intake). Male subjects must not donate sperm and female subjects must not donate oocytes as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy"}
- {"criterion_text":"- Subjects should be affiliated to a social security regimen (for French sites only)"}
Exclusion criteria
- {"criterion_text":"- Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study"}
- {"criterion_text":"- Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or nvestigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study"}
- {"criterion_text":"- Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of Adverse Events (AEs) in ABX464 treated subjects.","definition_or_measurement_approach":"Number of AEs recorded in ABX464-treated subjects as reported in-study (safety reporting of adverse events)."}
Recruitment
- Planned Sample Size
- 42
- Recruitment Window Months
- 75
- Consent Approach
- Participants must "understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures". Subject information and informed consent forms are available for adults (L1_SIS and ICF - adults) and there are pregnancy follow-up ICFs; local patient-facing documents are provided in multiple languages.
Methods
- Recruitment of subjects who previously completed the ABX464-102 or ABX464-104 clinical studies
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 161
Spain
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 24-02-2025
- Processing Time Days
- 269
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Centro Medico Teknon-Grupo Quironsalud
- Department Name
- Servicio de Aparato Digestivo
- Principal Investigator Name
- Miquel Sans Cuffi
- Principal Investigator Email
- sans@dr.teknon.es
- Contact Person Name
- Miquel Sans Cuffi
- Contact Person Email
- sans@dr.teknon.es
Slovenia
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 24-02-2025
- Processing Time Days
- 269
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- UNIVERZITETNI KLINICNI CENTER MARIBOR
- Department Name
- Klinika za interno medicino, Oddelek za gastroenterologijo
- Principal Investigator Name
- Andreja Ocepek
- Principal Investigator Email
- andreja.ocepek@ukc-mb.si
- Contact Person Name
- Andreja Ocepek
- Contact Person Email
- andreja.ocepek@ukc-mb.si
- Site Name
- Splosna Bolnisnica Murska Sobota
- Department Name
- Gastroenterološki Odsek
- Principal Investigator Name
- Miran Gerič
- Principal Investigator Email
- miran.geric@sb-ms.si
- Contact Person Name
- Miran Gerič
- Contact Person Email
- miran.geric@sb-ms.si
Italy
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 08-01-2026
- Processing Time Days
- 594
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- IBD center
- Principal Investigator Name
- Alessandro Armuzzi
- Principal Investigator Email
- alessandro.armuzzi@hunimed.eu
- Contact Person Name
- Alessandro Armuzzi
- Contact Person Email
- alessandro.armuzzi@hunimed.eu
- Site Name
- IRCCS Ospedale Sacro Cuore Don Calabria
- Department Name
- Gastroenterology
- Principal Investigator Name
- Angela Variola
- Principal Investigator Email
- angela.variola@sacrocuore.it
- Contact Person Name
- Angela Variola
- Contact Person Email
- angela.variola@sacrocuore.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Gastroenterology
- Principal Investigator Name
- Antonio Gasbarrini
- Principal Investigator Email
- antonio.gasbarrini@unicatt.it
- Contact Person Name
- Antonio Gasbarrini
- Contact Person Email
- antonio.gasbarrini@unicatt.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 640
- Number Of Sites
- 4
- Number Of Participants
- 19
Sites
- Site Name
- Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
- Department Name
- Debreceni Egészségügyi Központ
- Principal Investigator Name
- Gyula G. Kiss
- Principal Investigator Email
- gkissgyula@gmail.com
- Contact Person Name
- Gyula G. Kiss
- Contact Person Email
- gkissgyula@gmail.com
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- I. Belgyógyászat Gasztroenterológiai Osztály
- Principal Investigator Name
- István Rácz
- Principal Investigator Email
- raczi@petz.gyor.hu
- Contact Person Name
- István Rácz
- Contact Person Email
- raczi@petz.gyor.hu
- Site Name
- DRC Kft.
- Department Name
- Gastroenterology
- Principal Investigator Name
- József Pauer
- Principal Investigator Email
- jozsef.pauer@drc.hu
- Contact Person Name
- József Pauer
- Contact Person Email
- jozsef.pauer@drc.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Hematológiai Klinika
- Principal Investigator Name
- Zsolt Tulassay
- Principal Investigator Email
- tulassay.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Tulassay
- Contact Person Email
- tulassay.zsolt@med.semmelweis-univ.hu
France
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 622
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Service de Gastro-entérologie
- Principal Investigator Name
- Clémence Lombois
- Principal Investigator Email
- clombois@chu-grenoble.fr
- Contact Person Name
- Clémence Lombois
- Contact Person Email
- clombois@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service Hépato-Gastro-Entérologie
- Principal Investigator Name
- Arnaud Bourreille
- Principal Investigator Email
- arnaud.bourreille@chu-nantes.fr
- Contact Person Name
- Arnaud Bourreille
- Contact Person Email
- arnaud.bourreille@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service d’Hépato-Gastroentérologie et Transplantation
- Principal Investigator Name
- Romain Altwegg
- Principal Investigator Email
- r-altwegg@chu-montpellier.fr
- Contact Person Name
- Romain Altwegg
- Contact Person Email
- r-altwegg@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Service de Gastro-entérologie
- Principal Investigator Name
- Xavier Roblin
- Principal Investigator Email
- xavier.roblin@chu-st-etienne.fr
- Contact Person Name
- Xavier Roblin
- Contact Person Email
- xavier.roblin@chu-st-etienne.fr
- Site Name
- Centre Medico Chirurgical Ambroise Pare Hartmann
- Department Name
- Institut des MICI
- Principal Investigator Name
- Yoram Bouhnik
- Principal Investigator Email
- yoram.bouhnik@institutdesmici.fr
- Contact Person Name
- Yoram Bouhnik
- Contact Person Email
- yoram.bouhnik@institutdesmici.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 598
- Number Of Sites
- 13
- Number Of Participants
- 58
Sites
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Monika Augustyn
- Principal Investigator Email
- cmplejady@gmail.com
- Contact Person Name
- Monika Augustyn
- Contact Person Email
- cmplejady@gmail.com
- Site Name
- Metabolica Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Robert Witek
- Principal Investigator Email
- robertwitek1@gmail.com
- Contact Person Name
- Robert Witek
- Contact Person Email
- robertwitek1@gmail.com
- Site Name
- 1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zaklad opieki zdrowotnej W Lublinie
- Department Name
- Gastroenterology
- Principal Investigator Name
- Przemyslaw Zając
- Principal Investigator Email
- sekretariat@1wszk.pl
- Contact Person Name
- Przemyslaw Zając
- Contact Person Email
- sekretariat@1wszk.pl
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Department Name
- Internal medicine
- Principal Investigator Name
- Piotr Napora
- Principal Investigator Email
- szpital@cbk.wroc.pl
- Contact Person Name
- Piotr Napora
- Contact Person Email
- szpital@cbk.wroc.pl
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Tomasz Dworzanski
- Principal Investigator Email
- neuromed.lublin@gmail.com
- Contact Person Name
- Tomasz Dworzanski
- Contact Person Email
- neuromed.lublin@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
- Department Name
- Gastroenterology
- Principal Investigator Name
- Łukasz Wolański
- Principal Investigator Email
- lancius@poczta.onet.pl
- Contact Person Name
- Łukasz Wolański
- Contact Person Email
- lancius@poczta.onet.pl
- Site Name
- Appletreeclinics Network Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Grazyna Kulig
- Principal Investigator Email
- appletree@appletree.com.pl
- Contact Person Name
- Grazyna Kulig
- Contact Person Email
- appletree@appletree.com.pl
- Site Name
- Termedia Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jacek Paszkowski
- Principal Investigator Email
- badania@cbktermedica.pl
- Contact Person Name
- Jacek Paszkowski
- Contact Person Email
- badania@cbktermedica.pl
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Jaroslaw Kierkuś
- Principal Investigator Email
- j.kierkus@med-net.pl
- Contact Person Name
- Jaroslaw Kierkuś
- Contact Person Email
- j.kierkus@med-net.pl
- Site Name
- Santa Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Maria Wiśniewska-Jarosińska
- Principal Investigator Email
- badania.kliniczne@swietarodzina.com.pl
- Contact Person Name
- Maria Wiśniewska-Jarosińska
- Contact Person Email
- badania.kliniczne@swietarodzina.com.pl
- Site Name
- Centrum Medyczne Oporow
- Department Name
- Gastroenterology
- Principal Investigator Name
- Radoslaw Kempiński
- Principal Investigator Email
- badania@cmoporow.com
- Contact Person Name
- Radoslaw Kempiński
- Contact Person Email
- badania@cmoporow.com
- Site Name
- Trialmed Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Beata Neneman
- Principal Investigator Email
- biuro@trialmed.pl
- Contact Person Name
- Beata Neneman
- Contact Person Email
- biuro@trialmed.pl
- Site Name
- Medicome Sp. z o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Beata Mroziak
- Principal Investigator Email
- Medicome.badania@gmail.com
- Contact Person Name
- Beata Mroziak
- Contact Person Email
- Medicome.badania@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 598
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- Maag-, Darm-, Leverziekte
- Principal Investigator Name
- Bram Verstockt
- Principal Investigator Email
- bram.verstockt@uzleuven.be
- Contact Person Name
- Bram Verstockt
- Contact Person Email
- bram.verstockt@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Gastro-enterologie en hepatologie
- Principal Investigator Name
- Elisabeth Macken
- Principal Investigator Email
- elisabeth.macken@uza.be
- Contact Person Name
- Elisabeth Macken
- Contact Person Email
- elisabeth.macken@uza.be
Germany
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 600
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik 1 - Gastroenterologie und Hepatologie
- Principal Investigator Name
- Irina Blumenstein
- Principal Investigator Email
- blumenstein@em.uni-frankfurt.de
- Contact Person Name
- Irina Blumenstein
- Contact Person Email
- blumenstein@em.uni-frankfurt.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Gastroenterologie, Hepatologie und Endokrinologie
- Principal Investigator Name
- Ursula Seidler
- Principal Investigator Email
- seidler.ursula@mh-hannover.de
- Contact Person Name
- Ursula Seidler
- Contact Person Email
- seidler.ursula@mh-hannover.de
- Site Name
- Studiengesellschaft BSF UG (haftungsbeschraenkt)
- Department Name
- Gastroenterology/hepatology
- Principal Investigator Name
- Lars Fechner
- Principal Investigator Email
- dr.fechner@gastro-halle.de
- Contact Person Name
- Lars Fechner
- Contact Person Email
- dr.fechner@gastro-halle.de
Austria
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 598
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
- Principal Investigator Name
- Walter Reinisch
- Principal Investigator Email
- walter.reinisch@meduniwien.ac.at
- Contact Person Name
- Walter Reinisch
- Contact Person Email
- walter.reinisch@meduniwien.ac.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Universitätsklinik für Innere Medizin I, Gastroenterologie
- Principal Investigator Name
- Herbert Tilg
- Principal Investigator Email
- herbert.tilg@i-med.ac.at
- Contact Person Name
- Herbert Tilg
- Contact Person Email
- herbert.tilg@i-med.ac.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 599
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Nemocnice Slany
- Department Name
- Interní oddělení
- Principal Investigator Name
- Martin Peterka
- Principal Investigator Email
- martin.peterka@nemsl.cz
- Contact Person Name
- Martin Peterka
- Contact Person Email
- martin.peterka@nemsl.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Gastroenterologické a hepatologické oddělení
- Principal Investigator Name
- Jan Martínek
- Principal Investigator Email
- jan.martinek@fnusa.cz
- Contact Person Name
- Jan Martínek
- Contact Person Email
- jan.martinek@fnusa.cz
Slovakia
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 696
- Number Of Sites
- 3
- Number Of Participants
- 13
Sites
- Site Name
- Gastro I. s.r.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Bohuš Bunganič
- Principal Investigator Email
- gastrobunganic@gmail.com
- Contact Person Name
- Bohuš Bunganič
- Contact Person Email
- gastrobunganic@gmail.com
- Site Name
- Cliniq s.r.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Tibor Hlavatý
- Principal Investigator Email
- gastro@polibez.sk
- Contact Person Name
- Tibor Hlavatý
- Contact Person Email
- gastro@polibez.sk
- Site Name
- Endomed s.r.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Miroslav Fedurco
- Principal Investigator Email
- endomed@endomed.sk
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- endomed@endomed.sk
Sponsor
Primary sponsor
- Full Name
- Abivax
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 3, 8
- Name
- ORACLE Deutschland B.V. & Co. KG
- Responsibilities
- sponsorDuties codes: 7
- Name
- Scope International AG
- Responsibilities
- sponsorDuties codes: 1,10,11,12,5,6,7
Third parties
- {"country":"Germany","full_name":"ORACLE Deutschland B.V. & Co. KG","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Italy","full_name":"Latis S.r.l.","duties_or_roles":"sponsorDuties codes: 1, 15 (Site management; duties are applicable only for sites in Italy)","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Ilife Consulting","duties_or_roles":"sponsorDuties codes: 1, 15 (Site management; duties are applicable only for sites in France)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"GBA Central Lab Services GmbH","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 3, 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Scope International AG","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6,7","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ABX464
- Active Substance
- Obefazimod
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 25 mg
- Dose Levels
- 25 mg
- Frequency
- Once daily
- Maximum Dose
- 25 mg
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