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

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    198
  • sponsor
    EA Pharma Co., Ltd.
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Updated on 20 May 2020
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Investigator
Public Relations Group
Primary Contact
AJM300/CT3 trial site 71 (0.0 mi away) Contact
+81 other location
mesalamine
hematochezia

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.

Details
Treatment Placebo, AJM300
Clinical Study IdentifierNCT03531892
SponsorEA Pharma Co., Ltd.
Last Modified on20 May 2020

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Eligibility

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Inclusion Criteria

Is your age between 16 yrs and 74 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
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
Serious heart disease
Renal impairment
Hepatic impairment
Participants with a history of serious drug induced allergy with unknown cause
Participants with malignant tumor or those whose treatments were completed in less than 5 years
Participants with apparent psychological signs
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
Participants who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc
Participants who are participants of another clinical study including follow-up observation at the time of informed consent
Participants who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol
Participants who received investigational drugs in the study of AJM300
Participants determined to be ineligible for participation in this study by the investigator or sub-investigator
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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