A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.

Phase 1

Active, not recruiting

• Conditions: Moderate to severe ulcerative colitis.; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-003420-16-IT
• Lead Sponsor: IRCCS ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Adult patients (age = 18 years and < 75 years)
- Established diagnosis of UC (confirmed clinically, endoscopically and histologically) since at least 3 months
- Disease duration no longer than 24 months before the screening visit
- Ongoing oral 5-ASA treatment =1.6g/day
- Having objective signs of moderate-to-severe UC activity, defined by a total Mayo score of 6 to 12
- Proctitis, left-sided or extensive UC
- Ability to perform study requirements
- Ability to give informed consent according to ICH/ GCP, and national/local
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Have received any kind of treatment approved for UC (thiopurine, biologics, tofacitinib) apart from 5-ASA compounds, sulphasalazine or EcN during their UC history
- Currently receiving local or systemic steroids (past steroids treatments are accepted)
- Have concomitant history of segmental colitis associated to diverticula
- Have active infections during the screening phase (patients can be rescreened after the infection is resolved
- Have concomitant anti-HBcAb+ and HBsAg- at screening
- Have a diagnosis of Crohn's disease
- Have any contra-indication to study drugs or procedures
- Are pregnant or in active breastfeeding at the time of inclusion.
- Have planned intestinal surgery at time of randomization
- Any contra-indication to anti-TNF therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified