Clinical trial • Not applicable • Gastroenterology

MESALAZINE for Ulcerative colitis

Not applicable trial of MESALAZINE for Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-01-2026
First CTIS Authorization Date
30-04-2026

Trial design

Randomised, two strategies: 1) switch to mesalazine monotherapy (oral mesalazine formulations as used in the study; mesalazine products listed in part i, typical dosing up to 4 g/day per smpc). 2) continue thiopurines (azathioprine 1–2.5 mg/kg/day or mercaptopurine 0.75–1.5 mg/kg/day) at stable doses.-controlled Not applicable trial across 15 sites in Spain.

Randomised
Yes
Comparator
Two strategies: 1) Switch to mesalazine monotherapy (oral mesalazine formulations as used in the study; mesalazine products listed in Part I, typical dosing up to 4 g/day per SmPC). 2) Continue thiopurines (azathioprine 1–2.5 mg/kg/day or mercaptopurine 0.75–1.5 mg/kg/day) at stable doses.
Target Sample Size
304
Trial Duration For Participant
730

Eligibility

Recruits 304 No vulnerable populations selected. Written informed consent is required from participants (see inclusion criterion: "9. Written informed consent."). Subject information and informed consent forms for adults are provided (Spanish)..

Vulnerable Population
No vulnerable populations selected. Written informed consent is required from participants (see inclusion criterion: "9. Written informed consent."). Subject information and informed consent forms for adults are provided (Spanish).

Inclusion criteria

  • {"criterion_text":"- 1. Age 60 years or older.\n- 2. Established diagnosis of ulcerative colitis according to ECCO criteria.\n- 3. Treatment with azathioprine (AZA; 1–2.5 mg/kg/day) or mercaptopurine (MP; 0.75–1.5 mg/kg/day) for ≥5 consecutive years, at stable doses (minimum effective dose without adverse effects) during the last 12 months.\n- 4. In the case of concomitant treatment with oral mesalazine, stable doses for the last 12 months.\n- 5. Clinical remission maintained for ≥3 years, in the investigator's opinion, defined as: i. Absence of flare-ups requiring systemic corticosteroids (oral or IV) or biological agents. ii. The use of stable oral mesalazine and/or topical rectal treatments is permitted if the dose has remained stable over the last 12 months.\n- 6. Objective clinical remission at the inclusion visit: (1) Partial Mayo index ≤2 (with rectal bleeding subindex equal to 0).\n- 7. Endoscopic remission confirmed by colonoscopy performed within 12 months prior to study inclusion with endoscopic Mayo subindex=0 according to clinical practice.\n- 8. Subclinical inflammatory remission: Baseline faecal calprotectin ≤150 mg/kg, measured approximately 1 month (+/- 1 week) prior to randomisation.\n- 9. Written informed consent."}

Exclusion criteria

  • {"criterion_text":"- 1. Ulcerative proctitis (maximum extent observed <25 cm during the course of the disease).\n- 10. Neutrophil count <1500x10⁶ cells/mm³, lymphocytes <500x10⁶ cells/mm³, platelets <120,000x10⁶ cells/mm³, haemoglobin <12 g/dL (women) or 13 g/dL (men) at the time of inclusion.\n- 2. Total or segmental colectomy\n- 3. Ileoanal reservoir\n- 4. History of complex perianal disease\n- 5. Intolerance to oral 5-ASA\n- 6. Current or previous treatment with any selective immunomodulator or advanced therapy approved for the treatment of ulcerative colitis for any indication.\n- 7. Cessation of topical treatment (mesalazine or steroids) in the 3 months prior to inclusion\n- 8. CRF with creatinine ≥2mg/dl (glomerular filtration rate ≤ 30mL/min/1.73m2)\n- 9. Abnormal liver function tests (AST, ALT, alkaline phosphatase or GGT elevated >2 times the upper limit of normal) at the time of inclusion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Biological recurrence: faecal calprotectin >250 µg/g confirmed in two consecutive samples OR clinical recurrence requiring intensification of treatment within 24 months.","definition_or_measurement_approach":"Biological recurrence defined as faecal calprotectin >250 µg/g confirmed in two consecutive samples OR clinical recurrence requiring intensification of treatment within 24 months."}

Secondary endpoints

  • {"endpoint_text":"- Time to relapse","definition_or_measurement_approach":"Time from randomisation to clinical relapse (as defined in protocol)."}
  • {"endpoint_text":"- Clinical recurrence rate","definition_or_measurement_approach":"Proportion of participants experiencing clinical recurrence within follow-up period."}
  • {"endpoint_text":"- Colectomy rate","definition_or_measurement_approach":"Proportion of participants undergoing colectomy during follow-up."}
  • {"endpoint_text":"- Safety and adverse events","definition_or_measurement_approach":"Adverse events and safety outcomes as collected per protocol (including hospitalisations, events related to treatment)."}
  • {"endpoint_text":"- Mortality","definition_or_measurement_approach":"All-cause mortality and disease-related mortality during follow-up."}
  • {"endpoint_text":"- Hospitalisation rate (due to activity or adverse events)","definition_or_measurement_approach":"Rate of hospitalisations due to disease activity or adverse events during follow-up."}
  • {"endpoint_text":"- Treatment adherence (Morisky-Green scale)","definition_or_measurement_approach":"Adherence measured using the Morisky-Green scale."}

Recruitment

Planned Sample Size
304
Recruitment Window Months
36
Consent Approach
Written informed consent required from participants. Subject information and informed consent forms provided for adults (Spanish). No assent/minor-specific documents were provided (trial enrols adults ≥60 years).

Geography

Total Number Of Sites
15
Total Number Of Participants
304

Spain

Earliest CTIS Part Ii Submission Date
21-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
9
Number Of Sites
15
Number Of Participants
304

Sites

Site Name
Hospital Santa Ana
Department Name
Gastroenterology
Principal Investigator Name
Antonio Caballero
Principal Investigator Email
ogy1492@hotmail.com
Contact Person Name
Antonio Caballero
Contact Person Email
ogy1492@hotmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Gastroenterology
Principal Investigator Name
Raquel Vicente
Principal Investigator Email
raquelvicentelidon@gmail.com
Contact Person Name
Raquel Vicente
Contact Person Email
raquelvicentelidon@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Gastroenterology
Principal Investigator Name
María José García
Principal Investigator Email
garcia_maria86@hotmail.com
Contact Person Name
María José García
Contact Person Email
garcia_maria86@hotmail.com
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Gastroenterology
Principal Investigator Name
David Busquets
Principal Investigator Email
dbusquets.girona.ics@gencat.cat
Contact Person Name
David Busquets
Site Name
Consorci Sanitari Del Maresme
Department Name
Gastroenterology
Principal Investigator Name
Manuela Sampedro
Principal Investigator Email
msampedro@csdm.cat
Contact Person Name
Manuela Sampedro
Contact Person Email
msampedro@csdm.cat
Site Name
Hospital Alvaro Cunqueiro
Department Name
Gastroenterology
Principal Investigator Name
María Luisa De Castro
Principal Investigator Email
maria.luisa.decastro.parga@sergas.es
Contact Person Name
María Luisa De Castro
Site Name
Hospital Universitario De Burgos
Department Name
Gastroenterology
Principal Investigator Name
Beatriz Sicilia
Principal Investigator Email
cpablod@saludcastillayleon.es
Contact Person Name
Beatriz Sicilia
Contact Person Email
cpablod@saludcastillayleon.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Gastroenterology
Principal Investigator Name
Míriam Mañosa
Principal Investigator Email
mmanosa.germanstrias@gencat.cat
Contact Person Name
Míriam Mañosa
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Gastroenterology
Principal Investigator Name
Monstserrat Aceituno
Principal Investigator Email
maceituno@mutuaterrassa.es
Contact Person Name
Monstserrat Aceituno
Contact Person Email
maceituno@mutuaterrassa.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Gastroenterology
Principal Investigator Name
Rocío Ferreiro
Principal Investigator Email
rocioferstg@hotmail.com
Contact Person Name
Rocío Ferreiro
Contact Person Email
rocioferstg@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology
Principal Investigator Name
Eduardo Leo
Principal Investigator Email
eduardoleo70@gmail.com
Contact Person Name
Eduardo Leo
Contact Person Email
eduardoleo70@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Gastroenterology
Principal Investigator Name
Cristina Suárez
Principal Investigator Email
cristinajsuarezferrer@gmail.com
Contact Person Name
Cristina Suárez
Site Name
Hospital Clinic De Barcelona
Department Name
Gastroenterology
Principal Investigator Name
Ingrid Ordás
Principal Investigator Email
iordas@clinic.cat
Contact Person Name
Ingrid Ordás
Contact Person Email
iordas@clinic.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Gastroenterology
Principal Investigator Name
Eduard Brunet
Principal Investigator Email
eduardbrunet91@gmail.com
Contact Person Name
Eduard Brunet
Contact Person Email
eduardbrunet91@gmail.com
Site Name
Complejo Hospitalario Universitario De Ourense
Department Name
Gastroenterology
Principal Investigator Name
Coral Tejido
Principal Investigator Email
marta.llobet@iisgaliciasur.es
Contact Person Name
Coral Tejido
Contact Person Email
marta.llobet@iisgaliciasur.es

Sponsor

Primary sponsor

Full Name
Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
Organisation Type
Patient organisation/association
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Asacol 1600 mg comprimidos gastrorresistentes
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Asacol 800 mg comprimidos gastrorresistentes
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
PENTASA 500 mg comprimidos de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
PENTASA1 g comprimidos de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Pentasa 1g granulado de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Pentasa 2g granulado de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Pentasa 4 g granulado de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Salofalk 1000 mg granulado de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Salofalk 3 g granulado de liberación prolongada
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Claversal 500 mg comprimidos gastrorresistentes
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day
Investigational Product Name
Claversal 1 g comprimidos gastrorresistentes
Active Substance
MESALAZINE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised
Maximum Dose
4 g/day

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