Clinical trial • Phase IV • Gastroenterology
Guselkumab for Crohn's disease
Phase IV trial of Guselkumab for Crohn's disease. 210 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Crohn's disease
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-01-2026
- First CTIS Authorization Date
- 16-04-2026
Trial design
Phase IV trial in France.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 210
- Trial Duration For Participant
- 336
Eligibility
Recruits 210 Vulnerable population not selected. Only adults (18 years or older) may consent; patients under legal protection are explicitly excluded. Subject information and informed consent form for adults are provided (ICF adults FR)..
- Pregnancy Exclusion
- Pregnant or breastfeeding woman
- Vulnerable Population
- Vulnerable population not selected. Only adults (18 years or older) may consent; patients under legal protection are explicitly excluded. Subject information and informed consent form for adults are provided (ICF adults FR).
Inclusion criteria
- {"criterion_text":"- Patients with a diagnosis of Crohn's disease according to ECCO guidelines\n- Absence of contraindication to guselkumab\n- Active disease according to PRO2 (abdominal pain > 1 or stool frequency > 3), and faecal calprotectin > 250 ug/g\n- Objective active disease (as defined by endoscopy, MRI or IUS) within ≤ 2 month\n- 18 years of age or older at the time of informed consent\n- Not currently participating in any interventional research\n- Naïve or exposed to one or more advanced therapy"}
Exclusion criteria
- {"criterion_text":"- Previous exposure to an anti-IL23\n- Combination of an advanced therapy with guselkumab\n- Patient with ostomy\n- Pregnant or breastfeeding woman\n- Patient with perianal Crohn's disease predominant disease\n- Patients under legal protection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48","definition_or_measurement_approach":"Measured as steroid-free clinical remission at week 48 associated with fecal calprotectin < 250 ug/g."}
Secondary endpoints
- {"endpoint_text":"- Morphological remission at W48 assessed using the same tool that was used for the patient’s inclusion: endoscopy, MRI or IUS (major secondary endpoint)","definition_or_measurement_approach":"Morphological remission at week 48 assessed using the same imaging/endoscopic tool used at inclusion (endoscopy, MRI or intestinal ultrasound)."}
- {"endpoint_text":"- SFCR associated with fecal calprotectin < 250 ug/g at W12, W24 and W48","definition_or_measurement_approach":"Steroid-free clinical remission with fecal calprotectin < 250 ug/g measured at weeks 12, 24 and 48."}
- {"endpoint_text":"- Clinical remission at W12, W24, and W48","definition_or_measurement_approach":"Clinical remission assessed at weeks 12, 24 and 48 (as specified in the protocol)."}
- {"endpoint_text":"- Clinical response at W12","definition_or_measurement_approach":"Clinical response assessed at week 12 (protocol-specified criteria)."}
- {"endpoint_text":"- Biomarker remission at W12, W24, and W48","definition_or_measurement_approach":"Biomarker remission assessed at weeks 12, 24 and 48 (e.g., fecal calprotectin and other biomarkers as per protocol)."}
- {"endpoint_text":"- Need for guselkumab dose intensification (W12, W24, W48)","definition_or_measurement_approach":"Recorded need for dose intensification of guselkumab assessed at weeks 12, 24 and 48 (intensification defined in protocol, e.g., from 100 mg q8w to 200 mg q4w)."}
- {"endpoint_text":"- Change in Short IBD-Q (quality of life index) from baseline (W12, W24, and W48)","definition_or_measurement_approach":"Change in Short IBD-Q quality-of-life score from baseline measured at weeks 12, 24 and 48."}
Recruitment
- Planned Sample Size
- 210
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent is obtained from adult participants (18 years or older). A subject information sheet and informed consent form for adults in French is provided (L1_SIS and ICF adults FR). No paediatric assent procedures are applicable since minors are excluded.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 210
France
- Earliest CTIS Part Ii Submission Date
- 23-02-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 52
- Number Of Sites
- 31
- Number Of Participants
- 210
Sites
- Site Name
- CHRU De Nancy
- Department Name
- Gastroenterology
- Principal Investigator Name
- Bénédicte CARON
- Principal Investigator Email
- b.caron@chru-nancy.fr
- Contact Person Name
- Bénédicte CARON
- Contact Person Email
- b.caron@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Gastroenterology
- 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 Intercommunal Toulon / La Seine-Sur-Mer
- Department Name
- Gastroenterology
- Principal Investigator Name
- Camille SIBERTIN-BLANC
- Principal Investigator Email
- camille.sibertin-blanc@ch-toulon.fr
- Contact Person Name
- Camille SIBERTIN-BLANC
- Contact Person Email
- camille.sibertin-blanc@ch-toulon.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mathurin FUMERY
- Principal Investigator Email
- fumery.mathurin@chu-amiens.fr
- Contact Person Name
- Mathurin FUMERY
- Contact Person Email
- fumery.mathurin@chu-amiens.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Gastroenterology
- Principal Investigator Name
- David LAHARIE
- Principal Investigator Email
- david.lahaire@chu-bordeaux.fr
- Contact Person Name
- David LAHARIE
- Contact Person Email
- david.lahaire@chu-bordeaux.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Gastroenterology
- Principal Investigator Name
- Anne BOURRIER
- Principal Investigator Email
- anne.bourrier@aphp.fr
- Contact Person Name
- Anne BOURRIER
- Contact Person Email
- anne.bourrier@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Gastroenterology
- Principal Investigator Name
- Stéphane NANCEY
- Principal Investigator Email
- stephane.nancey@chu-lyon.fr
- Contact Person Name
- Stéphane NANCEY
- Contact Person Email
- stephane.nancey@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Gastroenterology
- Principal Investigator Name
- Cyrielle GILLETTA DE SAINT JOSEPH
- Principal Investigator Email
- gilletta.c@chu-toulouse.fr
- Contact Person Name
- Cyrielle GILLETTA DE SAINT JOSEPH
- Contact Person Email
- gilletta.c@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Gastroenterology
- Principal Investigator Name
- Julie FENDER
- Principal Investigator Email
- julie.fender@chu-dijon.fr
- Contact Person Name
- Julie FENDER
- Contact Person Email
- julie.fender@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Gastroenterology
- Principal Investigator Name
- Adrien NICOLAU
- Principal Investigator Email
- nicolau.a@chu-nice.fr
- Contact Person Name
- Adrien NICOLAU
- Contact Person Email
- nicolau.a@chu-nice.fr
- Site Name
- Centre Hospitalier De Roubaix
- Department Name
- Gastroenterology
- Principal Investigator Name
- Elodie MESSMER
- Principal Investigator Email
- elodie.messmer@ch-roubaix.fr
- Contact Person Name
- Elodie MESSMER
- Contact Person Email
- elodie.messmer@ch-roubaix.fr
- Site Name
- CHU Besancon
- Department Name
- Gastroenterology
- Principal Investigator Name
- Lucine VUITTON
- Principal Investigator Email
- lucine.vuitton@gmail.com
- Contact Person Name
- Lucine VUITTON
- Contact Person Email
- lucine.vuitton@gmail.com
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Gastroenterology
- Principal Investigator Name
- Astrid DE MAISSIN
- Principal Investigator Email
- astrid.demaissin@chd-vendee.fr
- Contact Person Name
- Astrid DE MAISSIN
- Contact Person Email
- astrid.demaissin@chd-vendee.fr
- Site Name
- Centre Hospitalier De Colmar
- Department Name
- Gastroenterology
- Principal Investigator Name
- Laurianne PLASTARAS
- Principal Investigator Email
- laurianne.plastaras@ch-colmar.fr
- Contact Person Name
- Laurianne PLASTARAS
- Contact Person Email
- laurianne.plastaras@ch-colmar.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mathias VIDON
- Principal Investigator Email
- mathias.vidon@chicreteil.fr
- Contact Person Name
- Mathias VIDON
- Contact Person Email
- mathias.vidon@chicreteil.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Gastroenterology
- Principal Investigator Name
- Maria NACHURY
- Principal Investigator Email
- maria.nachury@chu-lille.fr
- Contact Person Name
- Maria NACHURY
- Contact Person Email
- maria.nachury@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Gastroenterology
- Principal Investigator Name
- Guillaume BOUGUEN
- Principal Investigator Email
- guillaume.bouguen@chu-rennes.fr
- Contact Person Name
- Guillaume BOUGUEN
- Contact Person Email
- guillaume.bouguen@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Gastroenterology
- 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
- Assistance Publique Hopitaux De Paris
- Department Name
- Gastroenterology
- Principal Investigator Name
- Heithem SOLIMAN
- Principal Investigator Email
- heithem.soliman@aphp.fr
- Contact Person Name
- Heithem SOLIMAN
- Contact Person Email
- heithem.soliman@aphp.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Gastroenterology
- Principal Investigator Name
- Marion SIMON
- Principal Investigator Email
- marion.simon@imm.fr
- Contact Person Name
- Marion SIMON
- Contact Person Email
- marion.simon@imm.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Gastroenterology
- Principal Investigator Name
- Quentin LAURENT BADR
- Principal Investigator Email
- qlaurent@chu-reims.fr
- Contact Person Name
- Quentin LAURENT BADR
- Contact Person Email
- qlaurent@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Gastroenterology
- Principal Investigator Name
- Anne BOZON
- Principal Investigator Email
- aan-bozon@chu-montpellier.fr
- Contact Person Name
- Anne BOZON
- Contact Person Email
- aan-bozon@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gastroenterology
- Principal Investigator Name
- Anne-Laure PELLETIER
- Principal Investigator Email
- anne-Laure.pelletier@aphp.fr
- Contact Person Name
- Anne-Laure PELLETIER
- Contact Person Email
- anne-Laure.pelletier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Gastroenterology
- 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 De La Cote Basque
- Department Name
- Gastroenterology
- Principal Investigator Name
- Félix GOUTORBE
- Principal Investigator Email
- fgoutorbe@ch-cotebasque.fr
- Contact Person Name
- Félix GOUTORBE
- Contact Person Email
- fgoutorbe@ch-cotebasque.fr
- Site Name
- Bicetre Hospital
- Department Name
- Gastroenterology
- Principal Investigator Name
- Aurélien AMIOT
- Principal Investigator Email
- aurelienamiot@gmail.com
- Contact Person Name
- Aurélien AMIOT
- Contact Person Email
- aurelienamiot@gmail.com
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Gastroenterology
- Principal Investigator Name
- Anthony BUISSON
- Principal Investigator Email
- a_buisson@chu-clermont-ferrand.fr
- Contact Person Name
- Anthony BUISSON
- Contact Person Email
- a_buisson@chu-clermont-ferrand.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mélanie SERRERO
- Principal Investigator Email
- melanie.serrero@ap-hm.fr
- Contact Person Name
- Mélanie SERRERO
- Contact Person Email
- melanie.serrero@ap-hm.fr
- Site Name
- Hopital Beaujon
- Department Name
- Gastroenterology
- Principal Investigator Name
- Alexandre NUZZO
- Principal Investigator Email
- alexandre.nuzzo@aphp.fr
- Contact Person Name
- Alexandre NUZZO
- Contact Person Email
- alexandre.nuzzo@aphp.fr
- Site Name
- Clinique Pasteur
- Department Name
- Gastroenterology
- Principal Investigator Name
- Patrick FAURE
- Principal Investigator Email
- pfaure@clinique-pasteur.fr
- Contact Person Name
- Patrick FAURE
- Contact Person Email
- pfaure@clinique-pasteur.fr
- Site Name
- Centre Medico Chirurgical Ambroise Pare Hartmann
- Department Name
- Gastroenterology
- Principal Investigator Name
- Carmen STEFANESCU
- Principal Investigator Email
- carmen.stefanescu@institutdesmici.fr
- Contact Person Name
- Carmen STEFANESCU
- Contact Person Email
- carmen.stefanescu@institutdesmici.fr
Sponsor
Primary sponsor
- Full Name
- i-GETAID
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"Janssen","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
- Active Substance
- Guselkumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg every 8 weeks
- Dose Levels
- 100 mg q8w; 200 mg q4w (intensification)
- Frequency
- 100 mg q8w (standard); 200 mg q4w (intensified)
- Maximum Dose
- 1600 mg
- Dose Escalation Increase
- 100 mg q8w -> 200 mg q4w
- Investigational Product Name
- Guselkumab
- Active Substance
- Guselkumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg every 8 weeks
- Dose Levels
- 100 mg q8w; 200 mg q4w (intensification)
- Frequency
- 100 mg q8w (standard); 200 mg q4w (intensified)
- Maximum Dose
- 3400 mg
- Dose Escalation Increase
- 100 mg q8w -> 200 mg q4w
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