A Study to see effect and safety of PNB-001 capsules in Inflammatory bowel disease
- Conditions
- Health Condition 1: K509- Crohns disease, unspecifiedHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2022/10/046658
- Lead Sponsor
- PNB Vesper Life Science Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female Subjects aged between 18 and 65 years (both Inclusive).
2.Subjects who are able to understand and willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
3.Subjects on stable dose of oral Mesalamine of at least 2.4 gm/day for 2 weeks prior to screening.
Inclusion Criteria specific for Ulcerative Colitis Participants (Cohort 1)
1.Subjects have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole/part of left side of the colon [approximately 60 cm up from the anus (anal verge) to splenic flexure of colon], with mild to moderate active disease].
2.Subjects with Ulcerative Colitis Disease Activity Index (UCDAI) score of 4-10.
3.Rectal bleeding score of 1 or more at baseline
4.Mucosal appearance score (based on endoscopy) of 1 point or more at baseline
5.Stool Frequency subscore of 1 or more at baseline.
Inclusion Criteria specific for Crohn’s Disease Participants(Cohort 2)
1.Subjects have a documented history of Crohns Disease(CD) established at least 3 months prior to randomization by clinical and endoscopic evidence and corraborated by a histopathology report
2.Has mild to moderately active CD as determined by Crohns Disease Activity Index (CDAI) score of CDAI =200 and =400
3.Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1
1. Documented history of proximal or universal ulcerative colitis (pan colitis).
2. Subjects who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
3. Bowel resection within the previous 6 months.
4. Subjects with hemoglobin of = 10 g/dl at screening.
5. Subjects with ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
6. Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
7. Subjects with the following clinically significant laboratory abnormalities: SGOT, SGPT,
Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
8. Subjectswith abnormal Sr.Creatinine value of = 2 mg/dl at screening visit.
9. Subjects with current or recurrent Clostridium difficile infection.
10. History of biological therapy with agents like infliximab, adalimumab, etanercept, etc. within the previous 8 weeks of screening and Subjects in need of such therapy during the study period.
11. Subjects who received systemic steroids or immunosuppressant’s within the previous 4 weeks
of screening.
12. Subjects not able to withdraw and in need of continuing other immunosuppressant’s like sirolimus or cyclosporine during the study period.
13. Subjects with alcohol or drug abuse
14. Subjects with history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-
HCV) positive, or other clinically active liver disease at screening.
15. Subjects with Type 1 Diabetes or Type 2 Diabetes Mellitus whose diabetes has not been stable
and uncontrolled for the previous three months and with HbA1c value greater than 8% at
screening.
16. Subjects with cerebrovascular disease in the previous 3 months
17. Subjects diagnosed or suffering from any Oncological Conditions since last 2 years will be
excluded from the study.
18. Subjects with pre-existent renal function disorders, liver function disorders, cardiac disease,
uncontrolled hypertension, clinically important hematological, metabolic, psychiatric, central
nervous system (CNS) or pulmonary disease.
19. Female subjects who are pregnant or lactating or planning to become pregnant during the study
period. Females who are not ready to use acceptable contraceptive methods during the course
of study
20. Subjects who participated in any other clinical or post-marketing study (not only for study
drugs but also for medical devices) 30 days before signing the informed consent
21. Any condition which the study physician judges to preclude safe participation in the study or to
confound the evaluation of the study outcome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort 1: Ulcerative Colitis Disease <br/ ><br>1.Proportion of Subjects achieving clinical response at week 4 in test arm as compared to placebo arm. <br/ ><br> <br/ ><br>Cohort 2: Crohn’s Disease <br/ ><br>1.Percentage of Participants with a Clinical Response (CDAI <br/ ><br>Decrease from Baseline of =100 Points) at Week 4.Timepoint: Baseline, Day 14 and Day 28
- Secondary Outcome Measures
Name Time Method