Back to Crohns Disease And Colitis
NCT03733314
NCT03733314
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with Crohn's disease (affecting the small intestine, large intestine, or both) for at least 12 weeks before agreeing to take part.
- Your Crohn's disease is currently moderate to severe, based on two specific scoring systems used by doctors (confirm with trial site for exact score details).
- A camera examination of your bowel (colonoscopy) during the screening period showed a certain level of disease activity, including the presence of at least one ulcer, as confirmed by a central review team.
- You have previously tried steroid or immune-suppressing medicines but they did not work well enough, you could not tolerate them, or you became dependent on steroids; or you have tried a biologic medicine that either never worked, stopped working over time, or caused side effects you could not tolerate.
- If you are currently taking certain anti-inflammatory medicines or antibiotics for Crohn's disease, your dose has not changed in at least the last 4 weeks.
- If you are currently taking a low dose of oral steroid medication (such as prednisolone or budesonide), your dose has not changed in at least the last 4 weeks.
- If you are currently taking certain immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), your dose has not changed in at least the last 8 weeks.
Who may not be able to join:
- You have been diagnosed with ulcerative colitis or a type of bowel disease that is unclear between Crohn's and ulcerative colitis (called indeterminate colitis).
- You have been diagnosed with abnormal or pre-cancerous changes in the lining of your digestive tract.
- You currently have, or are suspected to have, a pocket of infection (abscess) in your abdomen.
- You have a stoma bag (artificial opening for waste), an ileo-anal pouch, or a fistula (an abnormal channel between body parts).
- You have a significant or symptomatic narrowing in your bowel that requires a procedure to widen it, or has been rated as severely narrow during your colonoscopy assessment.
- You have had part of your small bowel surgically removed and as a result have difficulty absorbing enough nutrition (known as short bowel syndrome).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
EA Pharma Co., Ltd.
Registry
clinicaltrials_gov
Start date
25 April 2019
Est. completion
16 March 2022
Where this trial is recruiting
🇨🇿 Czechia
🇭🇺 Hungary
🇯🇵 Japan
🇵🇱 Poland
🇷🇺 Russia
Primary endpoints
Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.