Clinical trial • Phase III • Gastroenterology

Ustekinumab for Ulcerative colitis

Phase III trial of Ustekinumab for Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
07-01-2026
First CTIS Authorization Date
08-04-2026

Trial design

Randomised, open-label, four active comparator strategies (randomised arms): infliximab first — arm title 'time to efficay : infliximab' (dose/schedule not specified in provided documents); ustekinumab first — initial iv infusion: 260 mg if <55 kg, 390 mg if 55–85 kg, or 520 mg if >85 kg at w0; first two sc injections (two injections of 45 mg each) at w8 and then every 8 weeks to maintain remission; intensify to 90 mg every 4 weeks if targets not achieved; vedolizumab first — arm title 'french current use : vedolizumab' (dose/schedule not specified in provided documents); filgotinib first — oral filgotinib 200 mg, one tablet once daily as long as treatment is effective.-controlled Phase III trial in France.

Randomised
Yes
Open Label
Yes
Comparator
Four active comparator strategies (randomised arms): Infliximab first — arm title 'Time to Efficay : Infliximab' (dose/schedule not specified in provided documents); Ustekinumab first — initial IV infusion: 260 mg if <55 kg, 390 mg if 55–85 kg, or 520 mg if >85 kg at W0; first two SC injections (two injections of 45 mg each) at W8 and then every 8 weeks to maintain remission; intensify to 90 mg every 4 weeks if targets not achieved; Vedolizumab first — arm title 'French Current Use : Vedolizumab' (dose/schedule not specified in provided documents); Filgotinib first — oral filgotinib 200 mg, one tablet once daily as long as treatment is effective.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
240
Trial Duration For Participant
730

Eligibility

Recruits 240 Patients must be capable of giving consent ("Patient capable of giving consent" required). Minors are explicitly excluded. Patients under guardianship, curatorship or safeguard of justice are excluded. Consent materials are provided (document L1_SIS AND ICF PATIENT is included in trial documents). There is an explicit language requirement (patients who do not master the French language are excluded), so consent is expected to be obtained in French; no separate assent process for minors is provided because minors are excluded..

Pregnancy Exclusion
- Pregnant or lactating women : a pregnancy test will be performed for women of childbearing age
Vulnerable Population
Patients must be capable of giving consent ("Patient capable of giving consent" required). Minors are explicitly excluded. Patients under guardianship, curatorship or safeguard of justice are excluded. Consent materials are provided (document L1_SIS AND ICF PATIENT is included in trial documents). There is an explicit language requirement (patients who do not master the French language are excluded), so consent is expected to be obtained in French; no separate assent process for minors is provided because minors are excluded.

Inclusion criteria

  • {"criterion_text":"-\tMale or female patients (using effective contraception and a negative pregnancy test for women of childbearing age) diagnosed with UC for at least 3 months"}
  • {"criterion_text":"-\tAge ≥ 18 years and ≤ 65 years"}
  • {"criterion_text":"-\tModerate to severe UC according to modified Mayo score (from 5 to 9)"}
  • {"criterion_text":"-\tWith endoscopic Mayo score ≥ 2"}
  • {"criterion_text":"-\tWith an inadequate response, failure, loss of response, or intolerance to 5-ASA, steroids, or immunosuppressants."}
  • {"criterion_text":"-\tPatient capable of giving consent"}
  • {"criterion_text":"-\tPatient covered by the French healthcare system"}

Exclusion criteria

  • {"criterion_text":"-\tUsual contra-indication to infliximab, filgotinib, vedolizumab or ustekinumab"}
  • {"criterion_text":"-\tSteroids > 20 mg/day within two weeks before inclusion"}
  • {"criterion_text":"-\tLow proctitis (disease limited to the rectum with an extent < 5 cm)"}
  • {"criterion_text":"-\tPrior history of thromboembolism events"}
  • {"criterion_text":"-\tPrior history of major cardiovascular problems (such as heart attack or stroke)"}
  • {"criterion_text":"-\tLong-standing smokers (> 40 pack years)"}
  • {"criterion_text":"-\tCrohn's disease"}
  • {"criterion_text":"-\tStoma or colectomy"}
  • {"criterion_text":"-\tPrior exposure to anti-TNF agents, anti-integrins, anti-interleukines 12 and 23 or JAK inhibitor"}
  • {"criterion_text":"-\tPrior exposure to other biologics or experimental drug"}
  • {"criterion_text":"-\tNo health insurance"}
  • {"criterion_text":"-\tPregnant or lactating women : a pregnancy test will be performed for women of childbearing age"}
  • {"criterion_text":"-\tPatients already included in biomedical research other than an observational study (e.g: registry, cohort)"}
  • {"criterion_text":"-\tConcomitant Clostridioides difficile infection"}
  • {"criterion_text":"-\tHIV infection"}
  • {"criterion_text":"-\tPatient who does not master the French language"}
  • {"criterion_text":"-\tPatient under guardianship, curatorship or safeguard of justice"}
  • {"criterion_text":"-\tMinors"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-\tRemission (composite criteria) = no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) AND faecal calprotectin < 150 µg/g AND no steroids. Remission will be assessed as a binary criterion (yes/no) each month (i.e. 4 weeks-period) between week 4 and week 52, the month being considered as the statistical unit and not the patient.","definition_or_measurement_approach":"Composite remission defined as: no rectal bleeding, stool frequency Mayo sub-score = 0, fecal calprotectin < 150 µg/g, and no steroids. Assessed monthly (4-week periods) between Week 4 and Week 52; binary outcome (yes/no); statistical unit = month."}

Secondary endpoints

  • {"endpoint_text":"-\t1)\tRemission within the first 24 months","definition_or_measurement_approach":"Remission assessed over the first 24 months (binary remission as per trial's composite definition)."}
  • {"endpoint_text":"-\t2)\tAbsence of symptoms within the first 12 or within the first 24 months (= no rectal bleeding, normalization of bowel habits (Mayo sub-score of stool frequency = 0) and no steroids.","definition_or_measurement_approach":"Absence of symptoms defined as no rectal bleeding, stool frequency sub-score = 0, and no steroids assessed at 12 and 24 months."}
  • {"endpoint_text":"-\t3)\tBiological remission (defined using levels of faecal calprotectin < 50 μg/g, < 150 μg/g, < 250 μg/g)","definition_or_measurement_approach":"Faecal calprotectin thresholds used to define biological remission: <50 µg/g, <150 µg/g, <250 µg/g at scheduled visits."}
  • {"endpoint_text":"-\t4)\tEndoscopic improvement (mayo endoscopic score (MES) ≤ 1) at W16, W52 and W104","definition_or_measurement_approach":"Endoscopic improvement defined as MES ≤ 1 assessed at Week 16, Week 52 and Week 104."}
  • {"endpoint_text":"-\t5)\tEndoscopic remission (MES = 0) at W16, W52 and W104","definition_or_measurement_approach":"Endoscopic remission defined as MES = 0 assessed at Week 16, Week 52 and Week 104."}
  • {"endpoint_text":"-\t6)\tHistological healing (Nancy index ≤ 1) at W16, W52 and W104","definition_or_measurement_approach":"Histological healing defined as Nancy index ≤ 1 assessed at Week 16, Week 52 and Week 104."}
  • {"endpoint_text":"-\t7)\tClinical remission (total Mayo score ≤ 2 without any subscore >1) at W16, W52 and W104","definition_or_measurement_approach":"Clinical remission defined as total Mayo score ≤ 2 with no subscore >1, assessed at Weeks 16, 52 and 104."}
  • {"endpoint_text":"-\t8)\tClinical remission (per Modified Mayo Score) is defined as stool frequency subscore (SFS) ≤1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1at W16, W52 and W104","definition_or_measurement_approach":"Modified Mayo Score criteria: SFS ≤1, RBS = 0, endoscopic subscore ≤1 assessed at Weeks 16, 52 and 104."}
  • {"endpoint_text":"-\t9)\tHisto-endoscopical mucosal improvement (HEMI) (endoscopic improvement and histologic remission) at W16, W52 and W104","definition_or_measurement_approach":"Combined endoscopic improvement and histologic remission (HEMI) assessed at Weeks 16, 52 and 104."}
  • {"endpoint_text":"-\t10)\tHisto-endoscopical mucosal healing (HEMH) (endoscopic and histologic remission) at W16, W52 and W104","definition_or_measurement_approach":"Combined endoscopic and histologic remission (HEMH) assessed at Weeks 16, 52 and 104."}
  • {"endpoint_text":"-\t11)\tSymptomatic remission (no rectal bleeding and normalization of bowel habits (SF Mayo sub-score ≤ 1) at each visit","definition_or_measurement_approach":"Symptomatic remission defined as no rectal bleeding and SFS Mayo sub-score ≤1 at each visit."}
  • {"endpoint_text":"-\t12)\tLevel of faecal calprotectin at each visit","definition_or_measurement_approach":"Quantitative faecal calprotectin measured at each visit."}
  • {"endpoint_text":"-\t13)\tRate and number of days spent in clinical remission","definition_or_measurement_approach":"Proportion of time and cumulative days in clinical remission recorded for each participant during follow-up."}
  • {"endpoint_text":"-\t14)\tAcceptability of drug regimen (numerical scale from 0 to 10) at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"Patient-reported acceptability via numerical scale 0–10 at specified weeks."}
  • {"endpoint_text":"-\t15)\tTime to drug failure","definition_or_measurement_approach":"Time from randomisation to drug failure (as defined in protocol) recorded."}
  • {"endpoint_text":"-\t16)\tTime to clinical response including each individual symptoms (rectal bleeding, bowel habits and urgency)","definition_or_measurement_approach":"Time from randomisation to first clinical response for overall and individual symptoms (rectal bleeding, bowel habits, urgency)."}
  • {"endpoint_text":"-\t17)\tPartial Mayo score and simple clinical colitis activity index (SCCAI) at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"Partial Mayo and SCCAI scores measured at listed visits."}
  • {"endpoint_text":"-\t18)\tRate and type of adverse events at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"Adverse event incidence and classification collected at specified visits."}
  • {"endpoint_text":"-\t19)\tColectomy rate at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"Number and proportion of participants undergoing colectomy recorded at specified visits/timepoints."}
  • {"endpoint_text":"-\t20)\tQuality of life assessed by the IBD questionnaire at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"IBDQ administered at specified visits to assess quality of life."}
  • {"endpoint_text":"-\t21)\tDisability assessed by IBD disability index at W8, W16, W24, W32, W42, W52, W76 and W104","definition_or_measurement_approach":"IBD-DI administered at specified visits to assess disability."}
  • {"endpoint_text":"-\t22)\tDisappearance of rectal bleeding, faecal urgency and normalization of bowel habits at W8, W16, W24, W32, W42, W52, W76 and W104.","definition_or_measurement_approach":"Assessment of specific symptom resolution (rectal bleeding, urgency, stool frequency) at listed visits."}

Recruitment

Planned Sample Size
240
Recruitment Window Months
48
Consent Approach
Informed consent must be provided by the participant ("Patient capable of giving consent"). Minors excluded. A subject information and informed consent form document is included (L1_SIS AND ICF PATIENT). Participants must master the French language (patients who do not master French are excluded), implying consent is obtained in French. No remote/digital consent methods or assent processes for minors are described in the provided materials.

Geography

Total Number Of Sites
29
Total Number Of Participants
240

France

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
15
Number Of Sites
29
Number Of Participants
240

Sites

Site Name
CHRU De Nancy
Department Name
gastroenterology
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
gastroenterology
Contact Person Name
Guillaume Bouguen
Site Name
Assistance Publique Hopitaux De Paris
Department Name
gastroenterology
Contact Person Name
Anne Wampach
Contact Person Email
anne.wampach@aphp.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
gastroenterology
Contact Person Name
Mathias Vidon
Contact Person Email
mathias.vidon@chicreteil.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
gastro enterology
Contact Person Name
Anthony Buisson
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
gastroenterology
Contact Person Name
Ludovic Caillo
Contact Person Email
ludovic.caillo@chu-nimes.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
gastroenterology
Contact Person Name
Sophie Geyl
Contact Person Email
sophie.geyl@chu-limoges.fr
Site Name
Centre Hospitalier D Avignon
Department Name
gastroenterology
Contact Person Name
Alban Benezech
Contact Person Email
benezech.alban@ch-avignon.fr
Site Name
Centre Hospitalier De Colmar
Department Name
gastroenterology
Contact Person Name
Laurianne Plastaras
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
gastroenterology
Contact Person Name
Philippe Ah-Soune
Contact Person Email
philippe.ah-soune@ch-toulon.fr
Site Name
Centre Hospitalier Valence
Department Name
gastroenterology
Contact Person Name
Céline Montuclard
Contact Person Email
cmontuclard@ch-valence.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
gastroenterology
Contact Person Name
Michael Collins
Contact Person Email
michael.collins@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
gastroenterology
Contact Person Name
Mathurin Fumery
Contact Person Email
fumery.mathurin@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
gastroenterology
Contact Person Name
Maria Nachury
Contact Person Email
maria.nachury@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
gastroenterology
Contact Person Name
Mathilde Barrau
Site Name
CHU Besancon
Department Name
gastroenterology
Contact Person Name
Lucine Vuitton
Contact Person Email
lvuitton-ec@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
gastro enterology
Contact Person Name
David Laharie
Contact Person Email
david.laharie@chu-bordeaux.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
gastroenterology
Contact Person Name
Astrid De Maissin
Contact Person Email
astrid.demaissin@ght85.fr
Site Name
Hospital La Croix Rousse Hcl
Department Name
gastroenterology
Contact Person Name
Stéphane Nancey
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Institut Mutualiste Montsouris
Department Name
gastroenterology
Contact Person Name
Marion Simon
Contact Person Email
marion.simon@imm.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
gastroenterology
Contact Person Name
Mélanie Serrero
Contact Person Email
melanie.serrero@ap-hm.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
gastroenterology
Contact Person Name
Driffa Moussata
Contact Person Email
d.moussata@chu-tours.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil Cedex)
Department Name
gastroenterology
Contact Person Name
Mathieu Uzzan
Contact Person Email
mathieu.uzzan@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
gastroenterology
Contact Person Name
Lucile Boivineau
Contact Person Email
l-boivineau@chu-montpellier.fr
Site Name
Hopital Saint Antoine
Department Name
gastroenterology
Contact Person Name
Philippe SEKSIK
Contact Person Email
philippe.seksik@aphp.fr
Site Name
Hopital Beaujon
Department Name
gastro enterology
Contact Person Name
Alexandre Nuzzo
Contact Person Email
alexandre.nuzzo@ap-hp.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
gastroenterology
Contact Person Name
Clémence Lombois
Contact Person Email
clombois@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
gastroenterology
Contact Person Name
Cyrielle Gilletta
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
gastroenterology
Contact Person Name
Adrien Nicolau
Contact Person Email
nicolau.a@chu-nice.fr

Sponsor

Primary sponsor

Full Name
University Hospital Of Clermont-Ferrand
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
STEQEYMA 130 mg concentrate for solution for infusion
Active Substance
Ustekinumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion; subcutaneous (described in product change)
Route
Intravenous infusion (initial), subcutaneous (maintenance injections described)
Authorisation Status
Authorised (marketing authorisation present)
Starting Dose
Initial IV infusion: 260 mg if < 55 kg, 390 mg if 55–85 kg, or 520 mg if > 85 kg at W0; thereafter first two SC injections (two injections of 45 mg each) at W8 and then every 8 weeks
Dose Levels
Initial IV 260 / 390 / 520 mg (weight-based); SC 2×45 mg (90 mg) q8w; intensification to 90 mg q4w if needed
Frequency
Initial single IV at W0; SC injections at W8 and every 8 weeks; intensification option 90 mg every 4 weeks
Maximum Dose
Intensification to 90 mg every 4 weeks described
Dose Escalation Increase
Initial IV (260/390/520 mg depending on weight) → SC 2×45 mg (90 mg) q8w → intensify to 90 mg q4w
Investigational Product Name
Remsima 100 mg powder for concentrate for solution for infusion
Active Substance
Infliximab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)
Investigational Product Name
Jyseleca 200 mg film-coated tablets
Active Substance
Filgotinib
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (marketing authorisation present)
Starting Dose
200 mg once daily (one tablet of 200 mg once daily)
Dose Levels
200 mg daily (maintenance); no escalation described except maintenance if target not achieved per protocol
Frequency
Once daily
Dose Escalation Increase
Initial 200 mg once daily; maintained at 200 mg once daily if targets not achieved
Investigational Product Name
Entyvio 300 mg powder for concentrate for solution for infusion
Active Substance
Vedolizumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present)

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