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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531892
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : November 29, 2021
Sponsor:
Collaborator:
Kissei Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( EA Pharma Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE May 9, 2018
First Posted Date  ICMJE May 22, 2018
Last Update Posted Date November 29, 2021
Actual Study Start Date  ICMJE June 6, 2018
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
Clinical Response Rate Based on Mayo Score [ Time Frame: At Week 8 ]
Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of Mayo score and the change or the actual value of individual subscales. Mayo score is used in clinical trials to assess ulcerative colitis (UC) disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • Clinical Remission Rate Based on Mayo Score [ Time Frame: At Week 8 ]
    Clinical remission rate is defined by the percentage of participants with Mayo score <=2 and no subscore greater than (>) 1.
  • Mucosal Healing Rate [ Time Frame: At Week 8 ]
    Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore <=1.
  • Complete Mucosal Healing Rate [ Time Frame: At Week 8 ]
    Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.
  • Clinical Response Rate Based on Partial Mayo Score [ Time Frame: At Week 8 ]
    Clinical response rate is defined by the percentage of participants who satisfy the combined definition of the change of the total value of partial Mayo score and the change or the actual value of individual subscales. Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total partial Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
  • Clinical Remission Rate Based on Partial Mayo Score [ Time Frame: At Week 8 ]
    Clinical remission rate is defined by the percentage of participants with partial Mayo score <=2 and no subscore >1.
  • Modified Clinical Remission Rate 1 [ Time Frame: At Week 8 ]
    Modified Clinical remission rate 1 is defined by percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, Stool frequency subscore =0 and Endoscopic subscore <=1.
  • Modified Clinical Remission Rate 2 [ Time Frame: At Week 8 ]
    Modified Clinical remission rate 2 is defined by the percentage of participants who satisfies the three conditions such as: rectal bleeding subscore =0, a decrease in the stool frequency subscore of at least 1 point or an absolute stool frequency subscore of 0 or 1 and Endoscopic subscore <=1.
  • Percentage of Rectal Bleeding Subscore of 0 [ Time Frame: At Week 8 ]
    Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.
  • Change From Baseline in Mayo score [ Time Frame: Baseline, Week 8 ]
    Mayo score is used in clinical trials to assess UC disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
  • Change From Baseline in Partial Mayo Score [ Time Frame: Baseline, Week 8 ]
    Partial Mayo score is used in clinical trials to assess UC disease activity. It consists of 3 subscales: stool frequency, rectal bleeding and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3= severe disease condition. The total Mayo score ranges from 0 to 9, with higher scores indicating more severe disease.
  • Change From Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 8 ]
  • Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts) [ Time Frame: Baseline, Week 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
Official Title  ICMJE Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: AJM300
    AJM300 film-coated tablets.
    Other Name: Carotegrast methyl
  • Drug: Placebo
    Placebo matched to AJM300 tablets.
Study Arms  ICMJE
  • Experimental: AJM300 960mg/dose
    Participants will orally receive AJM300 960 mg tablets, three times daily after meals for 8 weeks.
    Intervention: Drug: AJM300
  • Placebo Comparator: Placebo
    Participants will orally receive AJM300 placebo-matching tablets, three times daily after meals for 8 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
198
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 74 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531892
Other Study ID Numbers  ICMJE AJM300/CT3
JapicCTI-183924 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( EA Pharma Co., Ltd. )
Study Sponsor  ICMJE EA Pharma Co., Ltd.
Collaborators  ICMJE Kissei Pharmaceutical Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Eisai Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP