Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05456893
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients ≥ 18 years of age (at the time of signing the ICF)
* Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
* Moderate to severe active UC defined by Mayo Score ≥ 6
* Moderate to severe active UC defined by endoscopy score of ≥2
* Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
* In case of treatment with corticosteroid: stable dose for at least 3 weeks prior to baseline, dosage ≤ 20 mg prednisone
* Indication for an endoscopy for the assessment of disease activity as for standards of care and current guidelines
* Able to comply with the study procedures
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and able to sign informed consent form
Exclusion Criteria:
* Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
* Absolute contraindications to endoscopy procedures or complication during previous endoscopy
* Bleeding disorders
* Indication for surgery for UC
* Rectal topical therapy (enemas or suppositories) ≤ 2 weeks prior to baseline
* Treatment with \> 20 mg prednisone within 3 weeks prior to baseline
* Anaemia (haemoglobin \< 10 g/dl) at baseline
* Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:
* Pregnant, parturient or breastfeeding woman
* Minor person (non-emancipated)
* Adult person under legal protection (any form of public guardianship)
* Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05456893
Study Brief:
Protocol Section:
NCT05456893