Ulcerative Colitis
Conditions
Interventions
investigational material(s)
Generic name etc : E6007
INN of investigational material : -
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investiga
Sponsors
EA Pharma Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria 1. Japanese patients aged from 20 to 74 years at the time of informed consent. 2. The patients with a diagnosis of ulcerative colitis[UC] based on the Revised Diagnostic Criteria for ulcerative colitis issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan [2013] at least 4 weeks before the start of administration of study drug. 3. Active UC patients who had complete Mayo score between 6 and 10 points with an endoscopic subscore >= 2, and rectal bleeding subscore >= 1 at Baseline. 4. Patients who are currently being treated with oral 5-ASA or immunomodulator or corticosteroid with inadequate response or intolerance, or corticosteroid dependent. 5. Patients being seen an outpatient basis. 6. Has voluntarily consented, in writing, to participate in this study and is able and willing to comply with the requirements of this study protocol.
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria 1. Reduction in partial Mayo score of >= 3 points at Baseline from Screening. 2. Diagnosed with right-sided or segmental colitis, and proctitis from a Baseline endoscopy. 3. Received any anti-TNF agents for over 2 years, or within 12 weeks prior to Baseline. 4. History of colectomy, or planning to have surgery for treatment of UC until the end of treatment period at Screening or Baseline. 5. White blood cell count below 3,000/micro L at Screening. 6. History or suspected complication of central nervous system disorder found at Screening or Baseline. 7. Current complication or suspected of malignancy or toxic megacolon at Screening or Baseline. 8. History or complication of colonic dysplasia at Screening or Baseline. 9. History of any severe drug allergy at Screening or Baseline. 10. Received a live vaccine within 4 weeks prior to Baseline. 11. QTc repeatedly above 450 ms on the ECG testing at Screening. 12. Female patients who are breast feeding or pregnant at Screening or Baseline. 13. Refusal to use medically suitable contraception [both the patient and the patient's partner] throughout the entire study period, if the patient is male capable of reproduction or female of childbearing potential. 14. Female patients who want to become pregnant or male patients whom partners want to become pregnant from the date of informed consent to the last date of post-observation period. 15. Evidence of clinically significant disease that in the opinion of the investigator[s] could affect the patient's safety or interfere with the study assessments at Screening or Baseline. 16. History of any medical conditions or concomitant medical conditions that in the opinion of the investigator[s] would compromise the patient's ability to safely complete the study at Screening or Baseline. 17. A positive finding in human immunodeficiency virus antigen and antibody test at Screening. 18. In tests conducted at Screening, a positive finding for any of the following: hepatitis B virus surface antigen, hepatitis B virus surface antibody, hepatitis B virus core antibody, or hepatitis C virus antibody. 19. Any result other than negative in tuberculosis test at Screening. 20. Findings indicating a history of tuberculosis on chest X-ray at Screening. 21. History of drug or alcohol dependency or abuse within approximately the last 2 years prior to Screening or Baseline. 22. Use of psychotropic medicine except the treatment at Screening or Baseline. 23. Currently enrolled in another clinical trial or used any investigational drug or device within 16 weeks prior to informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficasy Mayo score | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Safety Laboratory test, vital signs, chest X-ray test, standard 12-lead ECG, adverse events | — |
Countries
Japan
Outcome results
None listed