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

Colitis, Ulcerative Clinical Trial

Official title:

Phase III Study of AJM300 in Patients With Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531892
• Other study ID #: AJM300/CT3
• Secondary ID: JapicCTI-183924
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2018
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: March 28, 2023
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• AJM300
AJM300 film-coated tablets.
• Placebo
Placebo matched to AJM300 tablets.

Locations

Country	Name	City	State
Japan	AJM300/CT3 trial site 40	Ageo	Saitama
Japan	AJM300/CT3 trial site 5	Ageo	Saitama
Japan	AJM300/CT3 trial site 79	Akashi	Hyogo
Japan	AJM300/CT3 trial site 18	Asahikawa	Hokkaido
Japan	AJM300/CT3 trial site 26	Asahikawa	Hokkaido
Japan	AJM300/CT3 trial site 60	Ashikaga	Tochigi
Japan	AJM300/CT3 trial site 61	Bunkyo	Tokyo
Japan	AJM300/CT3 trial site 68	Bunkyo	Tokyo
Japan	AJM300/CT3 trial site 44	Chiba
Japan	AJM300/CT3 trial site 59	Chiyoda	Tokyo
Japan	AJM300/CT3 trial site 30	Chuo	Tokyo
Japan	AJM300/CT3 trial site 43	Fukuoka
Japan	AJM300/CT3 trial site 58	Fukuoka
Japan	AJM300/CT3 trial site 69	Fukuoka
Japan	AJM300/CT3 trial site 35	Fukuyama	Hiroshima
Japan	AJM300/CT3 trial site 67	Gifu
Japan	AJM300/CT3 trial site 31	Hachioji	Tokyo
Japan	AJM300/CT3 trial site 17	Hamamatsu	Shizuoka
Japan	AJM300/CT3 trial site 77	Higashiosaka	Osaka
Japan	AJM300/CT3 trial site 39	Hirosaki	Aomori
Japan	AJM300/CT3 trial site 49	Hirosaki	Aomori
Japan	AJM300/CT3 trial site 28	Hiroshima
Japan	AJM300/CT3 trial site 36	Hiroshima
Japan	AJM300/CT3 trial site 74	Hiroshima
Japan	AJM300/CT3 trial site 55	Isesaki	Gunma
Japan	AJM300/CT3 trial site 12	Kamakura	Kanagawa
Japan	AJM300/CT3 trial site 82	Kasama	Ibaraki
Japan	AJM300/CT3 trial site 11	Kashiwa	Chiba
Japan	AJM300/CT3 trial site 51	Kashiwa	Chiba
Japan	AJM300/CT3 trial site 34	Kobe	Hyogo
Japan	AJM300/CT3 trial site 23	Kofu	Yamanashi
Japan	AJM300/CT3 trial site 15	Kurashiki	Okayama
Japan	AJM300/CT3 trial site 70	Kurashiki	Okayama
Japan	AJM300/CT3 trial site 53	Kurume	Fukuoka
Japan	AJM300/CT3 trial site 62	Kyoto
Japan	AJM300/CT3 trial site 7	Kyoto
Japan	AJM300/CT3 trial site 81	Matsuyama	Ehime
Japan	AJM300/CT3 trial site 56	Minato	Tokyo
Japan	AJM300/CT3 trial site 66	Minato	Tokyo
Japan	AJM300/CT3 trial site 80	Mitaka	Tokyo
Japan	AJM300/CT3 trial site 19	Morioka	Iwate
Japan	AJM300/CT3 trial site 22	Nagaoka	Nigata
Japan	AJM300/CT3 trial site 48	Nagasaki
Japan	AJM300/CT3 trial site 41	Nagoya	Aichi
Japan	AJM300/CT3 trial site 57	Nagoya	Aichi
Japan	AJM300/CT3 trial site 63	Nagoya	Aichi
Japan	AJM300/CT3 trial site 64	Nishinomiya	Hyogo
Japan	AJM300/CT3 trial site 37	Oita
Japan	AJM300/CT3 trial site 65	Okayama
Japan	AJM300/CT3 trial site 1	Osaka
Japan	AJM300/CT3 trial site 76	Osakasayama	Osaka
Japan	AJM300/CT3 trial site 20	Saga
Japan	AJM300/CT3 trial site 25	Saga
Japan	AJM300/CT3 trial site 14	Sagamihara	Kanagawa
Japan	AJM300/CT3 trial site 32	Sagamihara	Kanagawa
Japan	AJM300/CT3 trial site 73	Sakura	Chiba
Japan	AJM300/CT3 trial site 2	Sapporo	Hokkaido
Japan	AJM300/CT3 trial site 3	Sapporo	Hokkaido
Japan	AJM300/CT3 trial site 4	Sapporo	Hokkaido
Japan	AJM300/CT3 trial site 45	Sendai	Miyagi
Japan	AJM300/CT3 trial site 50	Sendai	Miyagi
Japan	AJM300/CT3 trial site 78	Sendai	Miyagi
Japan	AJM300/CT3 trial site 29	Shimotsuga	Tochigi
Japan	AJM300/CT3 trial site 38	Shinagawa	Tokyo
Japan	AJM300/CT3 trial site 21	Shinjuku	Tokyo
Japan	AJM300/CT3 trial site 52	Shinjuku	Tokyo
Japan	AJM300/CT3 trial site 8	Shunan	Yamaguchi
Japan	AJM300/CT3 trial site 16	Takamatsu	Kagawa
Japan	AJM300/CT3 trial site 10	Takatsuki	Osaka
Japan	AJM300/CT3 trial site 24	Tikushino	Fukuoka
Japan	AJM300/CT3 trial site 72	Tokorozawa	Saitama
Japan	AJM300/CT3 trial site 27	Toyama
Japan	AJM300/CT3 trial site 9	Toyoake	Aichi
Japan	AJM300/CT3 trial site 33	Toyohashi	Aichi
Japan	AJM300/CT3 trial site 42	Toyota	Aichi
Japan	AJM300/CT3 trial site 47	Tsu	Mie
Japan	AJM300/CT3 trial site 75	Tsukuba	Ibaraki
Japan	AJM300/CT3 trial site 54	Urayasu	Chiba
Japan	AJM300/CT3 trial site 71	Utsunomiya	Tochigi
Japan	AJM300/CT3 trial site 46	Yokkaichi	Mie
Japan	AJM300/CT3 trial site 13	Yokohama	Kanagawa
Japan	AJM300/CT3 trial site 6	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.	Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Rate Based on Mayo Score	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.	At Week 8
Secondary	Clinical Remission Rate Based on Mayo Score	Clinical remission rate is defined by the percentage of participants with Mayo score <=2 and no subscore greater than (>) 1.	At Week 8
Secondary	Mucosal Healing Rate	Mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore <=1.	At Week 8
Secondary	Complete Mucosal Healing Rate	Complete mucosal healing rate is defined by the percentage of participants with Mayo endoscopic subscore =0.	At Week 8
Secondary	Clinical Response Rate Based on Partial Mayo Score	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.	At Week 8
Secondary	Clinical Remission Rate Based on Partial Mayo Score	Clinical remission rate is defined by the percentage of participants with partial Mayo score <=2 and no subscore >1.	At Week 8
Secondary	Modified Clinical Remission Rate 1	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.	At Week 8
Secondary	Modified Clinical Remission Rate 2	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.	At Week 8
Secondary	Percentage of Rectal Bleeding Subscore of 0	Percentage of rectal bleeding subscore of 0 means the percentage of participants with rectal bleeding score =0.	At Week 8
Secondary	Change From Baseline in Mayo score	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.	Baseline, Week 8
Secondary	Change From Baseline in Partial Mayo Score	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.	Baseline, Week 8
Secondary	Change From Baseline in Fecal Calprotectin		Baseline, Week 8
Secondary	Change From Baseline in Peripheral Blood White Blood Cell (WBC) Differentiation (Neutrophil, Eosinophil, Basophil, Lymphocyte, and Monocyte Counts)		Baseline, Week 8