MedTrace Logo

A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

NCT03531892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2023-07-21

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

AJM300

AJM300 film-coated tablets.

DRUG

Placebo

Placebo matched to AJM300 tablets.

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • EA Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2020-11-09
Completion
2023-03-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531892 on ClinicalTrials.gov