A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis (NCT03531892) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
Japan198 participantsStarted 2018-06-06
Plain-language summary
The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative colitis.
Who can participate
Age range
16 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants diagnosed with ulcerative colitis.
. Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment.
. Mayo Clinic scores of 6-10 .
. Endoscopic subscore greater than or equal to (\>=) 2.
. Rectal bleeding subscore \>=1.
. Participants with inadequate response or intolerant to oral 5-ASA
. Participants who are capable of providing written informed consent
Exclusion criteria
. Participants with extensive detachment of mucosa or deep ulcer.
. Participants with oral corticosteroid dependency.
. Participants with a complication of marked reduction of immune function.
. Participants who were clinically suspected to have a complication of infectious enteritis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.