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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	16 Years - 74 Years
Gender	All

More Inclusion & Exclusion Criteria

Major

Inclusion Criteria:

1. Participants diagnosed with ulcerative colitis. 2. Participants with moderate ulcerative colitis who satisfy all of the following criteria at Day of enrollment. 1. Mayo Clinic scores of 6-10 . 2. Endoscopic subscore greater than or equal to (>=) 2. 3. Rectal bleeding subscore >=1. 3. Participants with inadequate response or intolerant to oral 5-ASA. 4. Participants who are capable of providing written informed consent. Major

Exclusion Criteria:

1. Participants with extensive detachment of mucosa or deep ulcer. 2. Participants with oral corticosteroid dependency. 3. Participants with a complication of marked reduction of immune function. 4. Participants who were clinically suspected to have a complication of infectious enteritis. 5. Participants with a history or complication of serious infection within 1 year prior to the day of enrollment. 6. Participants with central nervous system (CNS) neurological symptoms. 7. Participants with the following criteria:

- Serious heart disease.

- Renal impairment.

- Hepatic impairment.

8. Participants with a history of serious drug induced allergy with unknown cause. 9. Participants with malignant tumor or those whose treatments were completed in less than 5 years. 10. Participants with apparent psychological signs. 11. Pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at Week 8, and women who do not consent to the use of appropriate birth control methods. 12. Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc. 13. Participants who are participants of another clinical study including follow-up observation at the time of informed consent. 14. Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol. 15. Participants who received investigational drugs in the study of AJM300. 16. Participants determined to be ineligible for participation in this study by the investigator or sub-investigator.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03531892
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	EA Pharma Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	IndustryIndustry
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Colitis, Ulcerative

Arms & Interventions

Arms

Experimental: AJM300 960mg/dose

Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.

Placebo Comparator: Placebo

Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.

Interventions

Drug: - AJM300

AJM300 film-coated tablets.

Drug: - Placebo

Placebo matched to AJM300 tablets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

AJM300/CT3 trial site 41, Nagoya, Aichi, Japan

Status

Recruiting

Address

AJM300/CT3 trial site 41

Nagoya, Aichi,

Site Contact

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