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 range16 Years – 74 Years

SexALL

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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.
✕. Participants with a history or complication of serious infection within 1 year prior to the day of enrollment.
✕. Participants with central nervous system (CNS) neurological symptoms.
✕. Participants with the following criteria:
✕. Participants with a history of serious drug induced allergy with unknown cause.

What they're measuring

Clinical Response Rate Based on Mayo Score

Timeframe: At Week 8

Trial details

NCT IDNCT03531892

SponsorEA Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-09

View on ClinicalTrials.gov More Colitis, Ulcerative trials