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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT03531892
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: EA Pharma Co., Ltd.
• Public title: A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
• Scientific title: Phase III Study of AJM300 in Patients With Active Ulcerative Colitis
• Date of first enrolment: June 6, 2018
• Target sample size: 198
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03531892
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Key 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.



Age minimum: 16 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: AJM300

Primary Outcome(s)

Clinical Response Rate Based on Mayo Score [Time Frame: At Week 8]

Secondary Outcome(s)

Change From Baseline in Partial Mayo Score [Time Frame: Baseline, Week 8]

Clinical Remission Rate Based on Partial Mayo Score [Time Frame: At Week 8]

Change From Baseline in Fecal Calprotectin [Time Frame: Baseline, Week 8]

Change From Baseline in Mayo score [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]

Percentage of Rectal Bleeding Subscore of 0 [Time Frame: At Week 8]

Complete Mucosal Healing Rate [Time Frame: At Week 8]

Modified Clinical Remission Rate 2 [Time Frame: At Week 8]

Modified Clinical Remission Rate 1 [Time Frame: At Week 8]

Clinical Response Rate Based on Partial Mayo Score [Time Frame: At Week 8]

Mucosal Healing Rate [Time Frame: At Week 8]

Clinical Remission Rate Based on Mayo Score [Time Frame: At Week 8]

Secondary ID(s)

JapicCTI-183924

AJM300/CT3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kissei Pharmaceutical Co., Ltd.