Health Condition 1: K509- Crohns disease, unspecified Health Condition 2: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: PNB001 50 mg: One capsule three times daily with water after meals with the stable dose of oral Mesalamine of at least 2.4 gm/day for 4 weeks
Intervention2: PNB001 100mg: One capsule th
Sponsors
PNB Vesper Life Science Pvt Ltd
Biosphere Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Ulcerative Colitis Disease 1.Proportion of Subjects achieving clinical response at week 4 in test arm as compared to placebo arm. Cohort 2: Crohn’s Disease 1.Percentage of Participants with a Clinical Response (CDAI Decrease from Baseline of =100 Points) at Week 4.Timepoint: Baseline, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Ulcerative Colitis Disease 1. Change from baseline in the Ulcerative Colitis Disease Activity Index (UCDAI) score at 4 weeks. 2. Change from baseline in Rectal bleeding score at 4 weeks. 3.Time to resolution of rectal bleeding within 4 weeks. 4.Change from baseline in Stool Frequency score at 4 weeks. 5.Time to normalization of stool frequency within 4 weeks. 6.Change from baseline in mucosal appearance score (based on colonoscopy) at 4 weeks. 7.Change in ESR, CRP, CD4, CD8, TNFa, IL6 and FC levels at 4 weeks from baseline. 8.Short Inflammatory Bowel Disease Questionnaire (SIBDQ) assessmentTimepoint: 28 Days;Cohort 2: Crohn’s Disease 1.Change from baseline in the Crohns Disease Activity Index (CDAI) score at 4 weeks. 2.Change from baseline in Stool Frequency score at 4 weeks. 3.Change in ESR, CRP, CD4, CD8, TNF a, IL6 and FC levels at 4 weeks from baseline. 4.Change from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) (based on colonoscopy) at 4 weeks. 5.Short Inflammatory Bowel Disease Questionnaire (SIBDQ).Timepoint: 28 Days;The assessment of safety will be based on the frequency of Adverse Events and changes in laboratory values.Timepoint: 28 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt.Ltd
Outcome results
None listed