Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852574
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-05-02
Brief Title:
CP101 for the Treatment of Ulcerative Colitis
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
CP101 for the Treatment of Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a dose ranging exploratory phase 1 pilot study to assess engraftment safety and efficacy of CP101 an oral microbiome therapeutic in participants with active mild-to-moderate Ulcerative colitis A total of 30 patients who meet eligibility criteria will be randomized 11 to either a short or extended induction dosing with CP101 An assessment of the microbiome will occur at baseline Day 6 Week 4 Week 8 Week 12 Week 16 and Week 24
Detailed Description:
This dose ranging exploratory phase 1 pilot study will assess engraftment safety and efficacy of CP101 an oral microbiome therapeutic in participants with active mild-to-moderate UC
Participants with mild-moderate disease defined as a complete Mayo score of 4 to 9 will be eligible for enrollment Eligible participants must have an endoscopic and
histologically confirmed diagnosis of mild-to-moderate UC Participants must have active disease at endoscopy Mayo endoscopic score1 performed during screening
Participants who meet eligibility criteria will be randomized 11 to either initial induction only or initial and extended induction dosing with CP101 Both arms will receive an initial induction dose of CP101 comprising 10 capsules daily for 5 days Participants will then either receive extended induction with a daily dosing of five CP101 capsules through Week 8 or matching placebo Both participants and PI will be blinded to treatment arm allocation
Participants will be assessed through Week 8 for the primary outcome engraftment Safety outcomes all AEs and safety laboratory values will be assessed through the 8 week treatment period In addition secondary efficacy outcomes of disease remission and response will be evaluated at Week 8 Participants will also be followed through Week 24 for long-term safety engraftment and clinical outcomes including but not limited to remission and response AEs will be recorded from informed consent through Week 24 trial visit Blood samples for safety laboratory analysis as well as blood and stool samples for biomarker assessments will be collected at scheduled trial visits per the Schedule of Assessments
The primary outcome engraftment of CP101 associated microbes will be measured utilizing two baseline samples prior to CP101 administration and the participants Week 8 stool sample following Randomization Additional stool sample collections for microbiome assessment will occur at Day 6 Week 4 8 12 16 and 24
Participants that experience on-study worsening of their UC or a severe flare requiring the administration of rescue therapy will be withdrawn from the study but not replaced They will be considered treatment failures and last values collected will be carried forward
This study will prospectively enroll approximately 30 adult participants at a single center
Participants with mild-moderate disease defined as a complete Mayo score of 4 to 9 will be eligible for enrollment Eligible participants must have an endoscopic and
histologically confirmed diagnosis of mild-to-moderate UC Participants must have active disease at endoscopy Mayo endoscopic score1 performed during screening
Participants who meet eligibility criteria will be randomized 11 to either initial induction only or initial and extended induction dosing with CP101 Both arms will receive an initial induction dose of CP101 comprising 10 capsules daily for 5 days Participants will then either receive extended induction with a daily dosing of five CP101 capsules through Week 8 or matching placebo Both participants and PI will be blinded to treatment arm allocation
Participants will be assessed through Week 8 for the primary outcome engraftment Safety outcomes all AEs and safety laboratory values will be assessed through the 8 week treatment period In addition secondary efficacy outcomes of disease remission and response will be evaluated at Week 8 Participants will also be followed through Week 24 for long-term safety engraftment and clinical outcomes including but not limited to remission and response AEs will be recorded from informed consent through Week 24 trial visit Blood samples for safety laboratory analysis as well as blood and stool samples for biomarker assessments will be collected at scheduled trial visits per the Schedule of Assessments
The primary outcome engraftment of CP101 associated microbes will be measured utilizing two baseline samples prior to CP101 administration and the participants Week 8 stool sample following Randomization Additional stool sample collections for microbiome assessment will occur at Day 6 Week 4 8 12 16 and 24
Participants that experience on-study worsening of their UC or a severe flare requiring the administration of rescue therapy will be withdrawn from the study but not replaced They will be considered treatment failures and last values collected will be carried forward
This study will prospectively enroll approximately 30 adult participants at a single center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None