Evaluation of biomarkers in BF treatment

JRCT ID: jRCTs031210326

Registered date:21/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 28/02/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Budesonide foam was administered as a study drug

Outcome(s)

Primary Outcome

Response rate of the study drug (ratio of patients with response*1 among the enrolled patients) and before-and-after comparison of LRG values at 0 and 6 weeks in patients with response (paired median test will be performed)
*1 Response is defined by MES of 0 or 1, the rectal bleeding sub-score of 0, and stool frequency sub-score of 1 or less at week 6.
*2: MES is evaluated by the Endoscopic Score Evaluation Committee.

Secondary Outcome

1. Percentage changes in biomarkers (serum LRG and serum CRP) values between baseline and Week 6 in patients stratified by achievement of remission (CMH/MH/CR). The Weilcoxon signed-rank test will be implemented.
2. The cut off value were calculated by ROC analysis of each biomarker (serum LRG and serum CRP) in patients stratified by achievement of remission (CMH / MH / CR)
3. Correlation between the efficacy of the study drug and inflammation type
4. Correlation between each sub-score of the Mayo score * 1 and biomarker (serum LRG and serum CRP) values
5. Correlation between serum LRG and serum CRP with inflammation type evaluated by cytokine expr
ession level (mRNA levels)
6. Histological evaluation of colonic mucosa by the Histological Evaluation Committee (evaluated by the Geboes Index, the Nancy Index, the Robert Histological Index)
* 1 MES is evaluated by the Endoscopic Score Evaluation Committee.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Include patients with mild to moderate UC who meet all the following 1 to 6.
1. Patients diagnosed with UC according to the ulcerative colitis/Crohn's disease diagnostic criteria and treatment guidelines (revised in 2019)
2. Patients whose total Mayo score evaluated on the eligibility confirmation date was 10 points or less and each sub-score met the following.
(1) Patients with MES >_ 2 at the most active site from the rectum to the sigmoid colon and <_ 1 at the proximal site beyond the sigmoid colon on colonoscopy performed on the eligibility confirmation date.
(2) Patients with a physician's general assessment score of 1-2 on the eligibility confirmation date.
3. Gender: Not specified.
4. Age: 16 years or older (at the time of acquisition of Consent)
5. Visit classification: Outpatient
6. Patients who can obtain written consent (however, if the patient is under 20 years old, obtain written consent from the substitute)

Exclude criteria

1.Patients who received the following pharmacotherapy or treatment within the period of time as shown below:
[Two weeks before the start date of study drug administration]
New addition of mesalazine preparation (enema / suppository) and salazosulfapyridine preparation (suppository)
Antidiarrheal drug
Bowel cleaning composition (Except used for pre-preparation of colonoscopy in this clinical study)
Laxatives (Except used for pre-preparation of colonoscopy in this clinical study)
Enema (Except used for pre-preparation of colonoscopy in this clinical study)
[Four weeks before the start date of study drug administration]
If the dose of Mesalazine formulations is over then 4.0 g/day (excluding Asacol tablets and Rialda tablets)
If the dose of Asacol tablets is over then 3.6 g/day
If the dose of Rialda tablets is over then 4.8 g/day.
If the dose of Salazosulfapyridine formulation is over then 8.0 g/day
Leukocytapheresis
Antibiotics or antibacterial drugs for the treatment of UC.
Live vaccines
[Eight weeks before the start date of study drug administration]
Corticosteroid formulations (oral, enema, suppositories, hemorrhoid treatment, inhalants, injections)
[Twelve weeks before the start date of study drug administration]
Immunomodulators(cyclosporine, tacrolimus, methotrexate, azathioprine,6-mercaptopurine)
Antibody preparation (anti-TNFa antibody agents, vedolizumab, ustekinumab)
JFK inhibitors (tofacitinib)
2. Patients who have changed the dosage or administration of the following drug therapies within the following period:
[One weeks before the start date of study drug administration]
Probiotics
[Two weeks before the start date of study drug administration]
Mesalazine preparation (enema / suppository), salazosulfapyridine preparation (suppository)
[Four weeks before the start date of study drug administration]
Mesalazine formulations (oral), salazosulfapyridine formulation preparation (oral)
3. Patients with a history of resection of the sigmoid colon or rectum (excluding polypectomy), or patients scheduled for surgical treatment of the gastrointestinal tract during the study period.
4. Patients who are suspected clinically to have infectious enteritis.
5. Patients with infectious diseases and deep mycoses for which there is no effective antibacterial agent.
6. Patients with serious heart disease, nephropathy, or hepatic disorder
7. Patients with (or suspected to diagnosed with) malignant tumor
8. Female patients who are pregnant, lactating, or who may be pregnant
9. Patients who wish to become pregnant during the administration period of this study drug, or female patients who do not agree with using any appropriate medical methods for contraception (concomitant use of intrauterine devices, pessaries, or partner condoms, etc. However, the use of oral contraceptives is excluded).
10. Patients with a history of allergic reaction to budesonide
11. Patients who are receiving desmopressin acetate hydrate
12. Patients who participated in other clinical trials within 12 weeks prior to any examination or observation specified in this study protocol
13. Other patients who are judged to be inappropriate for this study by the principal investigator, etc.

Related Information

• Primary Sponsor: Matsuoka Katsuyoshi
• Secondary Sponsor: EA Pharma Co., Ltd.