A Study to see effect and safety of PNB-001 capsules in Inflammatory bowel disease
- Conditions
- Crohns disease, unspecified, (2) ICD-10 Condition: K519||Ulcerative colitis, unspecified,
- Registration Number
- CTRI/2022/10/046658
- Lead Sponsor
- PNB Vesper Life Science Pvt Ltd
- Brief Summary
This study is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled Clinical study to evaluate the efficacy and safety of PNB-001 as an adjunct to Mesalamine compared to Mesalamine alone in Subjects with Inflammatory bowel disease.
Primary objective:
- To evaluate the efficacy of PNB-001 as an adjunct to Mesalamine compared to Mesalamine alone in Subjects with Inflammatory bowel disease.
Secondary objectives:
- To evaluate the safety of PNB-001 as an adjunct to Mesalamine compared to Mesalamine alone in Subjects with Inflammatory bowel disease
Cohort 1: Ulcerative Colitis Disease
Primary Endpoints
- Proportion of Subjects achieving clinical response at week 4 in test arm as compared to placebo arm.
Secondary Endpoints
- Change from baseline in the Ulcerative Colitis Disease Activity Index (UCDAI) score at 4 weeks.
- Change from baseline in Rectal bleeding score at 4 weeks.
- Time to resolution of rectal bleeding within 4 weeks.
- Change from baseline in Stool Frequency score at 4 weeks.
- Time to normalization of stool frequency within 4 weeks.
- Change from baseline in mucosal appearance score (based on colonoscopy) at 4 weeks.
- Change in ESR, CRP, CD4, CD8, TNFα, IL6 and FC levels at 4 weeks from baseline.
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) assessment.
Cohort 2: Crohn’s Disease
Primary Endpoints
- Percentage of Participants with a Clinical Response (CDAI Decrease from Baseline of ≥100 Points) at Week 4.
Secondary Endpoints
- Change from baseline in the Crohn’s Disease Activity Index CDAI) score at 4 weeks.
- Change from baseline in Stool Frequency score at 4 weeks.
- Change in ESR, CRP, CD4, CD8, TNFα, IL6 and FC levels at 4 weeks from baseline.
- Change from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) (based on colonoscopy) at 4 weeks.
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 45
- 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.
- Documented history of proximal or universal ulcerative colitis (pan colitis).
- 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.
- Bowel resection within the previous 6 months.
- Subjects with hemoglobin of ≤ 10 g/dl at screening.
- Subjects with ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
- Subjects with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
- Subjectswith abnormal Sr.Creatinine value of ≥ 2 mg/dl at screening visit.
- Subjects with current or recurrent Clostridium difficile infection.
- 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.
- Subjects who received systemic steroids or immunosuppressant’s within the previous 4 weeks of screening.
- Subjects not able to withdraw and in need of continuing other immunosuppressant’s like sirolimus or cyclosporine during the study period.
- 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.
- 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.
- 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.
- 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.
- 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 1.Percentage of Participants with a Clinical Response (CDAI Baseline, Day 14 and Day 28 Cohort 1: Ulcerative Colitis Disease Baseline, Day 14 and Day 28 Cohort 2: Crohn’s Disease Baseline, Day 14 and Day 28 Decrease from Baseline of ≥100 Points) at Week 4. Baseline, Day 14 and Day 28 1.Proportion of Subjects achieving clinical response at week 4 in test arm as compared to placebo arm. Baseline, Day 14 and Day 28
- Secondary Outcome Measures
Name Time Method Cohort 1: Ulcerative Colitis Disease 1. Change from baseline in the Ulcerative Colitis Disease Activity Index (UCDAI) score at 4 The assessment of safety will be based on the frequency of Adverse Events and changes in laboratory values. Cohort 2: Crohn’s Disease 1.Change from baseline in the Crohns Disease Activity Index (CDAI) score at 4 weeks.
Trial Locations
- Locations (8)
CIMETs Inamdar Mutispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
GI One Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Great Eastern Medical School and Hospital, Srikakulam
🇮🇳Srikakulam, ANDHRA PRADESH, India
Maulana Azad Medical College,(GIPMER)
🇮🇳Delhi, DELHI, India
Max Super Specialty Hospital, Vaishali
🇮🇳Ghaziabad, UTTAR PRADESH, India
Mysore Medical College & Research Institute and Associated Hospitals
🇮🇳Mysore, KARNATAKA, India
Navneet Memorial Hospital
🇮🇳Ahmadabad, GUJARAT, India
Rahate Surgical Hospital
🇮🇳Nagpur, MAHARASHTRA, India
CIMETs Inamdar Mutispeciality Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Sanjay SalunkhePrincipal investigator9823133390sanjaysalunkhe@gmail.com