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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

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

Not Recruiting

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

No

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