Trial Outcomes & Findings for A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M (NCT NCT02493712)

Last Updated: 2021-10-26

Results Overview

Percentage of patients in remission over a 6-week treatment period. Remission is defined as a modified UCDAI (Ulcerative Colitis Disease Activity Index) score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1). Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition. Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day\> normal), score 2 (3-4/day \>normal), score 3 (\>4/day\> normal) Mucosal appearance: score 1 (Erythema, decreased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-10-26

Participant Flow

Started recruitment on 2016/01/01 Completed recruitment on 2018/07/01

No patient was excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	High Dose High dose, twice a day for 6 weeks. High dose: 6 capsules of IBD98-M, twice a day	Placebo: C Placebo, twice a day Placebo: Placebo	Low Dose Low dose, twice a day for 6 weeks Low dose: 4 capsules of IBD98-M
Overall Study STARTED	16	18	17
Overall Study COMPLETED	14	12	11
Overall Study NOT COMPLETED	2	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose High dose, twice a day for 6 weeks. High dose: 6 capsules of IBD98-M, twice a day	Placebo: C Placebo, twice a day Placebo: Placebo	Low Dose Low dose, twice a day for 6 weeks Low dose: 4 capsules of IBD98-M
Overall Study Withdrawal by Subject	1	0	2
Overall Study Protocol Violation	0	0	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Physician Decision	0	1	0
Overall Study Lack of Efficacy	0	5	3

Baseline Characteristics

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose n=16 Participants High dose, twice a day for 6 weeks. High dose: 6 capsules of IBD98-M, twice a day	Placebo: C n=18 Participants Placebo, twice a day Placebo: Placebo	Low Dose n=17 Participants Low dose, twice a day for 6 weeks Low dose: 4 capsules of IBD98-M	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	49 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	43.1 years STANDARD_DEVIATION 12.23 • n=5 Participants	45.8 years STANDARD_DEVIATION 12.21 • n=7 Participants	36.6 years STANDARD_DEVIATION 10.68 • n=5 Participants	41.9 years STANDARD_DEVIATION 12.14 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	28 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized	16 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	51 participants n=4 Participants
Region of Enrollment Italy	16 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	51 participants n=4 Participants
UC remission	16 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The percentage of patients in remission at Week 6 is summarized for the ITT population.

Outcome measures

Outcome measures
Measure	High Dose Group n=16 Participants IBD98-M 1.2 g/day group	Low Dose Group n=17 Participants IBD98-M 0.8 g/day group	Placebo n=18 Participants Placebo capsule, 6 capsules/day
Remission Rate	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 weeks

Clinical improvement over a 6-weeks treatment period was defined as a ≥ 3 point reduction from Baseline in the modified UCDAI (Ulcerative Colitis Disease Activity Index ) score. Modified UCDAI scoring system is sum of following 4 subscores (parameters). Higher score means worst disease condition. Rectal bleeding: score 1 (Streaks of blood), score 2 (obvious blood), score 3 (Mostly Blood) Stool frequency: score 1 (1-2/day\> normal), score 2 (3-4/day \>normal), score 3 (\>4/day\> normal) Mucosal appearance: score 1 (Erythema, decrased vascular pattern, Minimal granularity), score 2 (Marked erythema, Friability, Granularity, Absent vascular pattern, Bleeding minimal trauma, No ulcerations), score 3 (Ulceration Spontaneous bleeding) Physician's Global Assessment: score 1 (mild), score 2 (Moderate), score 3 (Severe)

Outcome measures

Outcome measures
Measure	High Dose Group n=16 Participants IBD98-M 1.2 g/day group	Low Dose Group n=17 Participants IBD98-M 0.8 g/day group	Placebo n=18 Participants Placebo capsule, 6 capsules/day
Improvement Rate	5 Participants	3 Participants	3 Participants

Adverse Events

High Dose Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Low Dose Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Dose Group n=16 participants at risk IBD98-M 1.2 g/day group	Low Dose Group n=17 participants at risk IBD98-M 0.8 g/day group	Placebo n=18 participants at risk Placebo capsule, 6 capsules/day
Gastrointestinal disorders WORSENING OF ULCERATIVE COLITIS	0.00% 0/16 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	0.00% 0/17 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.6% 1/18 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality

Other adverse events

Other adverse events
Measure	High Dose Group n=16 participants at risk IBD98-M 1.2 g/day group	Low Dose Group n=17 participants at risk IBD98-M 0.8 g/day group	Placebo n=18 participants at risk Placebo capsule, 6 capsules/day
Gastrointestinal disorders Colitis ulcerative	0.00% 0/16 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	29.4% 5/17 • Number of events 5 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	16.7% 3/18 • Number of events 3 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality
Gastrointestinal disorders Abdominal pain	18.8% 3/16 • Number of events 3 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.9% 1/17 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	16.7% 3/18 • Number of events 3 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.9% 1/17 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	16.7% 3/18 • Number of events 3 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality
Gastrointestinal disorders Dyspesia	12.5% 2/16 • Number of events 2 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	0.00% 0/17 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.6% 1/18 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality
Gastrointestinal disorders Vomiting	0.00% 0/16 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.9% 1/17 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality	5.6% 1/18 • Number of events 1 • up to 8 weeks - 6 weeks treatment and 2 weeks follow-up The gastro disorder is not the high risk for mortality

Additional Information

YUCHIH, Chen

Holy Stone Healthcare Co., Ltd

Phone: 886287975966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place