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:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT03178669
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Established diagnosis of Ulcerative Colitis (UC)
* Moderately to severely active left sided UC assessed by central reading
* Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
* Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:
* Immunomodulators
* Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins
Exclusion Criteria:
* Suspicion of differential diagnosis
* Acute fulminant UC and/or signs of systemic toxicity
* UC limited to the rectum (disease which extend \<15 cm above the anal verge)
* History of malignancy
* History or presence of any clinically significant disorder
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus
* Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
* Serious active infection
* Gastrointestinal infections
* Currently receiving parenteral nutrition or blood transfusions
* Females who are lactating or have a positive serum pregnancy test
* Women of childbearing potential not using reliable contraceptive methods
* Concurrent participation in another clinical study
* Previous exposure to cobitolimod
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03178669
Study Brief:
Protocol Section:
NCT03178669