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The study on the efficacy and safety of budesonide enteric-coated extended-release tablets in cases with insufficient response to oral 5-ASA formulations or in cases of relapse (The study on the efficacy and safety of budesonide enteric-coated extended-release tablets in cases with insufficient response to oral 5-ASA formulations or in cases of relapse(BETA-UC-J))

BETA-UC-J

38

There were 35 subjects in the per-protocol set (PPS) who met the study protocol criteria , and their background information is as follows. Gender: Male (16 subjects) / Female (19 subjects) Median age (minimum-maximum): 46.0 years (19-78 years) Ulcerative colitis subtype: Pancolitis (19 cases: 54.3%), left-sided colitis (12 cases: 34.3%), proctitis (2 cases: 5.7%), right-sided/segmental colitis (1 case: 2.9%), unknown (1 case: 2.9%) Median duration since onset (minimum-maximum): 51.0 (7-338) months Median duration since the current active phase began (minimum-maximum): 28.0 (4-330) days

A total of 38 cases were enrolled in this study, and the largest analysis population (FAS: Full Analysis Set) also consisted of 38 cases. Six cases were discontinued. Within the FAS, there were three cases of protocol violations due to the use of prohibited concomitant medications; after excluding these, the population compliant with the study protocol (PPS: Per Protocol Set) consisted of 35 cases. The safety analysis population (SS: Safety Set) consisted of 38 cases.

Adverse events were reported in 7 of 38 subjects (18.4%), totaling 8 events. Adverse events reported in 5% or more of subjects were colitis in 3 subjects (7.9%) and limb edema in 2 subjects (5.3%). Adverse drug reactions (judged to have a "causal relationship" with the study drug) were reported in 2 of 38 subjects (5.3%), totaling 3 events. Limb edema occurred in 2 subjects (5.3%) and an acneiform rash in 1 subject; however, all cases were mild, and no unknown adverse drug reactions were observed.

The main results for the overall study were as follows. Primary endpoint: Rate of symptomatic remission at the final evaluation At the final evaluation, 19 of 33 patients achieved symptomatic remission, with a rate [95% CI] of 57.6% [39.2, 74.5]. This result met the projected sample size for the analysis and was close to the pre-specified expected rate of symptomatic remission of 50.0% [31.9, 68.1%]. Secondary Endpoints *Rate of symptomatic remission at weeks 4 and 8 The proportions [95% CI] of patients who achieved symptomatic remission at weeks 4 and 8 were 63.3% [43.9, 80.1] and 60.0% [40.6, 77.3], respectively. *Change in p-Mayo total score from Week 0 The mean changes in the p-Mayo total score from Week 0 at Weeks 4, 8, and at the final evaluation were -2.7, -2.9, and -2.6, respectively, with statistically significant decreases observed in all cases (p<0.001, Wilcoxon signed-rank test). *Changes from Week 0 in scores for bloody stools, bowel movement frequency, abdominal pain, and urgency All subscores-bloody stools, bowel movement frequency, abdominal pain, and urgency-showed statistically significant decreases at Weeks 4, 8, and the final evaluation compared to Week 0. Among subjects who had a score of 1 or higher at Week 0, the proportion that achieved a score of 0 at the final evaluation was 76.0% (19/25 cases) for the bloody stool subscore and 46.7% (14/30 cases) for the bowel movement frequency subscore. *Changes in the IBDQ from Week 0 The mean change in the IBDQ total score at Week 8 and the final evaluation were 30.2 and 28.6, respectively; both showed a statistically significant increase, indicating an improvement in quality of life (QOL). (p<0.001, Wilcoxon signed-rank test) Statistically significant increases were also observed in all subscores, indicating an improvement in QOL.

The rate of symptomatic remission at the final evaluation-the primary endpoint-was close to the pre-specified expected rate of symptomatic remission. Improvements in various clinical assessments, quality of life (QOL), and biomarkers were consistent, and patient adherence was good. No serious adverse events were observed, and no new adverse events or side effects requiring further investigation were identified in the safety assessment.

Aug. 21, 2026

Aug. 31, 2026

No

NA

https://jrct.mhlw.go.jp/latest-detail/jRCTs031250131

Suzuki Yasuo

Ginza Central Clinic

5th Floor, Ginza 1-chome Building, 1-15-4 Ginza, Chuo-ku, Tokyo, Japan

ys.celtic372@gmail.com

Suzuki Yasuo

Ginza Central Clinic

5th Floor, Ginza 1-chome Building, 1-15-4 Ginza, Chuo-ku, Tokyo, Japan

+81-3-5579-5995

ys.celtic372@gmail.com

Complete

May. 26, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1)Patients for whom written consent was obtained prior to the study by the patient himself or herself
2)Patients older than 18 years at the time of informed consent
3)Active ulcerative colitis patients with a p-Mayo total score between 2 and 7, inclusive, at baseline (Week 0), and a rectal bleeding subscore or a physician's global assessment (PGA) subscore of at least 1
4)Patients who have been treated with the same oral formulation of 5-ASA for at least 4 weeks at the beginning of the observation period (Week 0)
5)Patients who can continue treatment with the dosage and administration before the start of observation period, if they are using the restricted concomitant drugs specified in 5.5.1 at the start of the observation period (Week 0) for at least 4 weeks before the start of the observation period

1)Patients with contraindications to budesonide enteric-coated extended-release tablets (see package insert)
2)Patients using biological agents, JAK inhibitors, immunosuppressive agents (excluding azathioprine formulations), steroids (excluding budesonide enteric-coated extended-release tablets), budesonide rectal foam, and CAP therapy at the start of the observation period (Week 0)
3)Other patients who are judged by researchers and others as inappropriate for the present study

Both

mild to moderate ulcerative colitis

After eligibility is confirmed and written consent is obtained, the study participants will be administered budesonide enteric-coated extended-release tablets for 8 weeks. The dose of budesonide will be 9 mg orally once daily in the morning according to the dosage and administration instructions in the package insert.

D003093

The rates of symptomatic remission at Final Assessment

<Efficacy>
1) The rates of symptomatic remission at Week 4 and 8
2) The rates of clinical remission at Week 4 and 8/final assessment
3) The rates of clinical improvement at Week 4 and 8/final assessment
4) Change from Week 0 in p-Mayo total score at Week 4 and 8/final assessment
5) Change from Week 0 in rectal bleeding subscore at Week 4 and 8/Final Assessment
6) Change from Week 0 in stool frequency subscore at Week 4 and 8/final assessment
7) Change from Week 0 in abdominal pain score at Week 4 and 8/Final Assessment
8) Change from Week 0 in urgency score from Week 0 at Week 4 and 8/Final Assessment
9) Change from Week 0 in IBDQ at Week 8/Final Assessment
10) Adherence at Week 4 and Week 8/Final Assessment (number of tablets taken during the observation period divided by days taken)
11) Change from Week 0 in Biomarkers (CRPs, LRG, PGEMUM) at Weeks 4 and 8/Final Assessment
<Safety>
Incidence of adverse events and adverse drug reactions
<Others>
Multivariate and univariate analyses of background factors and evaluation of predictors of efficacy

+81-42-742-1130

April. 28, 2025

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