Clinical trial • Phase II • Gastroenterology
SAR444336 for Microscopic colitis
Phase II trial of SAR444336 for Microscopic colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Microscopic colitis
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 06-06-2025
- First CTIS Authorization Date
- 29-09-2025
Trial design
Randomised, matched placebo for test product (matched placebo) — dose and schedule not specified in the record-controlled Phase II trial across 24 sites in Denmark, France, Hungary and others.
- Randomised
- Yes
- Comparator
- Matched placebo for test product (matched placebo) — dose and schedule not specified in the record
- Target Sample Size
- 78
Eligibility
Recruits 78 No vulnerable populations selected (isVulnerablePopulationSelected:false). The record does not describe specific assent or parental consent procedures; standard informed consent from adult participants is indicated via available ICF documents..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected:false). The record does not describe specific assent or parental consent procedures; standard informed consent from adult participants is indicated via available ICF documents.
Inclusion criteria
- {"criterion_text":"- Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types)."}
- {"criterion_text":"- Receiving budesonide therapy."}
- {"criterion_text":"- Documented clinical remission from 2 weeks before screening."}
- {"criterion_text":"- At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide."}
- {"criterion_text":"- Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit."}
- {"criterion_text":"- All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception."}
Exclusion criteria
- {"criterion_text":"- Significant neutrophilic/eosinophilic infiltration, crypt abscesses, granulomata, or any evidence of IBD other than microscopic colitis."}
- {"criterion_text":"- Evidence of infectious diarrhea in the 3 months prior to randomization."}
- {"criterion_text":"- Other active diarrheal conditions or suspicion of drug-induced microscopic colitis at screening, or diarrhea predominant irritable bowel syndrome."}
- {"criterion_text":"- Any current active viral, bacterial, or fungal infection or any medically relevant infection having occurred within 3 weeks before randomization."}
- {"criterion_text":"- Previous bowel surgeries."}
- {"criterion_text":"- Planned surgery while receiving study treatment. Dental surgeries or other types of minor surgery requiring only local anesthetic are allowed."}
- {"criterion_text":"- Other immunologic disorder, except controlled diabetes or thyroid disorder receiving appropriate treatment."}
- {"criterion_text":"- Presence or history of drug hypersensitivity associated with eosinophilia in the past 6 months."}
- {"criterion_text":"- History or presence of alcohol or illicit drug abuse within the past 2 years."}
- {"criterion_text":"- Excessive consumption of beverages containing xanthine bases."}
- {"criterion_text":"- History of solid organ transplant."}
- {"criterion_text":"- Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 2 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin."}
- {"criterion_text":"- Have experienced any of the following within 12 months before screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage III or IV heart failure."}
- {"criterion_text":"- Participants with a history or presence of another significant illness such as renal, neurological, ophthalmological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic disease, metabolic, pulmonary or lymphatic."}
- {"criterion_text":"- Live attenuated vaccines within 6 weeks of randomization and during the study."}
- {"criterion_text":"- Currently receiving or had treatment within 12 months prior to screening with B or T cell depleting agents."}
- {"criterion_text":"- At screening, have abnormal laboratory values or ECG abnormalities."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants with sustained steroid-free clinical remission.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of study investigational medicinal product (IMP) permanent discontinuations and study withdrawals due to treatment-emergent adverse events (TEAEs).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Plasma concentrations of SAR444336","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of treatment-emergent anti-drug antibody (ADA) against SAR444336","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 78
- Recruitment Window Months
- 18
- Consent Approach
- Informed consent obtained from adult participants. Subject information and ICF documents (L1/L2) are available in multiple country/language versions (documents present for EN, FR, HU, IT, PL, SV, NL, DE, DA). Partner/pregnancy information forms are present (L1-sis-icf-partner-pregnancy files listed). No specific assent/parental consent procedures are described in the record.
Methods
- Country-specific recruitment materials (posters, flyers, brochures) — multiple language versions listed (EN, FR, HU, IT, PL, SV, NL, DE, DA).
- Advertisements and patient-facing materials (documents labelled advertisement, flyer, patient brochure).
- Doctor-to-doctor letters and headquarter emails (documents labelled dr-to-dr, material-headquarter-email).
- Visit planners and patient visit scheduling materials (documents labelled visit planner).
- Subject recruitment and retention / Advertising (responsibility assigned to Greenphire LLC in sponsor duties).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 78
Denmark
- Earliest CTIS Part Ii Submission Date
- 03-09-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Gastroenheden dep. 331
- Principal Investigator Name
- Signe Wildt
- Principal Investigator Email
- signe.wildt@regionh.dk
- Contact Person Name
- Signe Wildt
- Contact Person Email
- signe.wildt@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Mave- Tarmsygdomme Klinik C217
- Principal Investigator Name
- Anders Kirch Dige
- Principal Investigator Email
- andedige@rm.dk
- Contact Person Name
- Anders Kirch Dige
- Contact Person Email
- andedige@rm.dk
France
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service Hépato-gastro-entérologie
- Principal Investigator Name
- Pauline Riviere
- Principal Investigator Email
- pauline.riviere@chu-bordeaux.fr
- Contact Person Name
- Pauline Riviere
- Contact Person Email
- pauline.riviere@chu-bordeaux.fr
- Site Name
- Groupe Hospitalier Intercommunal Le Raincy Montfermeil
- Department Name
- Service Hépato-gastro-entérologie
- Principal Investigator Name
- Gilles Macaigne
- Principal Investigator Email
- gilles.macaigne@ght-gpne.fr
- Contact Person Name
- Gilles Macaigne
- Contact Person Email
- gilles.macaigne@ght-gpne.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Gastro -enterologie
- Principal Investigator Name
- Mathieu Uzzan
- Principal Investigator Email
- mathieu.uzzan@aphp.fr
- Contact Person Name
- Mathieu Uzzan
- Contact Person Email
- mathieu.uzzan@aphp.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 02-10-2025
- Processing Time Days
- 65
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- Belgyógyászat I.
- Principal Investigator Name
- Roland Fejes
- Principal Investigator Email
- rfejes@mail.fmkorhaz.hu
- Contact Person Name
- Roland Fejes
- Contact Person Email
- rfejes@mail.fmkorhaz.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Hematológiai Klinika
- Principal Investigator Name
- Emese Mihaly
- Principal Investigator Email
- emesemihaly@hotmail.com
- Contact Person Name
- Emese Mihaly
- Contact Person Email
- emesemihaly@hotmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 71
- Number Of Sites
- 4
- Number Of Participants
- 9
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Gastroenterologia ed enterologia
- Principal Investigator Name
- Davide Giuseppe Ribaldone
- Principal Investigator Email
- gianeugeniotontini@gmail.com
- Contact Person Name
- Davide Giuseppe Ribaldone
- Contact Person Email
- gianeugeniotontini@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Antonio Gasbarrini
- Principal Investigator Email
- antonio.gasbarrini@Unicatt.it
- Contact Person Name
- Antonio Gasbarrini
- Contact Person Email
- antonio.gasbarrini@Unicatt.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Gastroenterologia ed enterologia
- Principal Investigator Name
- Gian Eugenio Tontini
- Principal Investigator Email
- gianeugeniotontini@gmail.com
- Contact Person Name
- Gian Eugenio Tontini
- Contact Person Email
- gianeugeniotontini@gmail.com
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Gastroenterologia ed enterologia
- Principal Investigator Name
- Edoardo Vincenzo Savarino
- Principal Investigator Email
- edoardosavarino@gmail.com
- Contact Person Name
- Edoardo Vincenzo Savarino
- Contact Person Email
- edoardosavarino@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 18-06-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 104
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Region Oestergoetland
- Department Name
- Magtarmmedicinska kliniken, IBD mottagnignen
- Principal Investigator Name
- Andreas Munch
- Principal Investigator Email
- andreas.munch@regionostergotland.se
- Contact Person Name
- Andreas Munch
- Contact Person Email
- andreas.munch@regionostergotland.se
- Site Name
- Ersta Sjukhus-Ersta Hospital
- Department Name
- Medicinkliniken, Gastromedicin FoU-enhet
- Principal Investigator Name
- Per-Johan Lindfors
- Principal Investigator Email
- per-johan.lindfors@erstadiakoni.se
- Contact Person Name
- Per-Johan Lindfors
- Contact Person Email
- per-johan.lindfors@erstadiakoni.se
- Site Name
- Region Stockholm – SLSO
- Department Name
- Studieenheten Academic Specialist Center
- Principal Investigator Name
- Charlotte Hedin
- Principal Investigator Email
- charlotte.hedin@ki.se
- Contact Person Name
- Charlotte Hedin
- Contact Person Email
- charlotte.hedin@ki.se
Poland
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 39
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Medical Network Sp. z o.o.
- Principal Investigator Name
- Jaroslaw Kierkus
- Principal Investigator Email
- j.kierkus@wip.waw.pl
- Contact Person Name
- Jaroslaw Kierkus
- Contact Person Email
- j.kierkus@wip.waw.pl
- Site Name
- Manermed Sp. z o.o.
- Principal Investigator Name
- Maria Klopocka
- Principal Investigator Email
- mariaklopocka@cm-medis.pl
- Contact Person Name
- Maria Klopocka
- Contact Person Email
- mariaklopocka@cm-medis.pl
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Gastroenterologii i Chorób Wewnętrznych
- Principal Investigator Name
- Grazyna Rydzewska-Wyszkowska
- Principal Investigator Email
- grazyna.rydzewska@cskmswia.gov.pl
- Contact Person Name
- Grazyna Rydzewska-Wyszkowska
- Contact Person Email
- grazyna.rydzewska@cskmswia.gov.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 63
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- UZ Leuven
- Department Name
- Maag-, Darm-, Leverziekten
- 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
- Universitair Ziekenhuis Gent
- Department Name
- Maag-, Darm-, Leverziekten
- Principal Investigator Name
- Jeroen Geldof
- Principal Investigator Email
- jeroen.geldof@uzgent.be
- Contact Person Name
- Jeroen Geldof
- Contact Person Email
- jeroen.geldof@uzgent.be
Germany
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 70
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Innere Medizin I - Gastroenterologie
- Principal Investigator Name
- Karsten Bueringer
- Principal Investigator Email
- karsten.bueringer@med.uni-tuebingen.de
- Contact Person Name
- Karsten Bueringer
- Contact Person Email
- karsten.bueringer@med.uni-tuebingen.de
- Site Name
- Klinikum Ernst von Bergmann gGmbH
- Department Name
- Klinik für Gastroenterologie, Hepatologie, Infektiologie und Rheumatologie
- Principal Investigator Name
- Daniel C. Baumgart
- Principal Investigator Email
- daniel.baumgart@uni-potsdam.de
- Contact Person Name
- Daniel C. Baumgart
- Contact Person Email
- daniel.baumgart@uni-potsdam.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- jochen.klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- jochen.klaus@uniklinik-ulm.de
- Site Name
- CGBS GbR
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mate Knabe
- Principal Investigator Email
- knabe@gastroenterlogie-frankfurt.de
- Contact Person Name
- Mate Knabe
- Contact Person Email
- knabe@gastroenterlogie-frankfurt.de
- Site Name
- St. Marien Und St. Annastiftskrankenhaus
- Department Name
- Klinik für Innere Medizin, Gastroenterologie
- Principal Investigator Name
- Tanja Kuehbacher
- Principal Investigator Email
- tanja.kuehbacher@st-marienkrankenhaus.de
- Contact Person Name
- Tanja Kuehbacher
- Contact Person Email
- tanja.kuehbacher@st-marienkrankenhaus.de
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- Clinical Pharmacology & Bioanalysis
- Name
- Medidata Solutions Inc.
- Responsibilities
- Clinical Outcomes Assessment Instrument (eCOA)
- Name
- Suvoda LLC
- Name
- Greenphire LLC
- Responsibilities
- Subject recruitment and retention / Advertising
- Name
- Fisher Clinical Services UK Limited
Third parties
- {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"Auxiliary Medicinal Product (AxMP) Management","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Bioanalytical Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Clinical Outcomes Assessment Instrument (eCOA)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"Bioanalytical Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"Bioanalytical Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject recruitment and retention / Advertising","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"Ancillary Supply Management - Technics","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Clinical Pharmacology & Bioanalysis","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Pharmalink Sp. z o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SAR444336
- Active Substance
- SAR444336
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Investigational Product Name
- Matched placebo for test product
- Modality
- Other
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