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NCT05852574 · ClinicalTrials.gov registry record · Phase 1
CP101 for the Treatment of Ulcerative Colitis
A Phase 1 study of Ulcerative Colitis, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05852574: Active Phase 1 study of Ulcerative Colitis, sponsored by Brigham and Women's Hospital.
NCT05852574 is a Phase 1 study of Ulcerative Colitis that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05852574, a Phase 1 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 1:1 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.
Primary Outcome
Quantification of CP101-associated taxa following administration of CP101 that were absent at baseline (pre-CP101 administration)
Conditions Studied
Interventions
- DRUG CP-101
- DRUG CP-101 + Placebo
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What the registry record for NCT05852574 still lists
NCT05852574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which CP-101 is the first listed.
NCT05852574 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05852574 about?
NCT05852574 is a clinical study titled "CP101 for the Treatment of Ulcerative Colitis". 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 1:1 to either a short ...
What is the current status of trial NCT05852574?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-09-01. Estimated completion is 2025-12-01.
What conditions does trial NCT05852574 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT05852574?
The interventions under investigation include: CP-101 (DRUG), CP-101 + Placebo (DRUG).
Who is sponsoring clinical trial NCT05852574?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05852574 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05852574's enrollment target sits among peer trials
30 103rd of 122 higher than 18 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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