CP101 for the Treatment of Ulcerative Colitis

NCT05852574 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2023P001470
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm

  Quantification of CP101-associated taxa following administration of CP101 that were absent at baseline (pre-CP101 administration)

  8 weeks

• To evaluate the safety and tolerability of CP101

  Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)

  8 weeks

Secondary Outcomes (3)

• To evaluate the effect of CP101 on induction of clinical remission

  8 weeks

• To evaluate the effect of CP101 on induction of clinical response

  8 weeks

• To evaluate the effect of CP101 on induction of endoscopic remission

  8 weeks

Study Arms (2)

CP101

EXPERIMENTAL

Extended Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive an extended induction daily dose of five CP101 capsules through Week 8.

Drug: CP-101

CP101 + Placebo

PLACEBO COMPARATOR

Short Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive 5 capsules of placebo through Week 8.

Drug: CP-101 + Placebo

Interventions

CP-101 DRUG

CP101 is an investigational oral microbiome drug designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent CDI. CP101 contains live microbial communities, derived from rigorously screened human donor stool that is tested, stabilized, characterized, and formulated into capsules designed specifically for delivery into the small bowel for release, to avoid potential degradation by gastric acid.

CP101

CP-101 + Placebo DRUG

The placebo in this trial will be presented in capsules that are identical in size, smell, texture, and appearance to those of the CP101 capsules. These will be produced by the BWH investigational drug service

CP101 + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Male or female ≥18 years of age
• Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic criteria
• Active mild-moderate UC as determined by colonoscopy approximately 10-21 days prior to randomization into the study. (flexible sigmoidoscopy permitted if subject has had a full colonoscopy within 12 months of baseline)
• Mild-moderate UC, defined by a complete Mayo score to include: the sum of rectal bleeding, stool frequency, endoscopic findings and physician global assessment sub-scores totaling ≥4 and ≤9, with each individual sub-group score ≥1.)
• Disease at least 15 cm from anal verge
• Stable dosing of concomitant medication

You may not qualify if:

• Severe or refractory UC defined as Mayo score ≥10
• Disease limited to distal proctitis
• Fever \> 38.3°C
• Known history of Crohn's disease or indeterminate colitis
• Inability to ingest capsules (e.g., severe nausea, vomiting, gastroparesis, gastric outlet obstruction, dysphagia and/or history of chronic aspiration).
• Known or suspected toxic megacolon and/or known small bowel ileus
• Patients with active intestinal obstruction
• Antibiotic use within the prior 1 month before randomization
• Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
• Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment
• Clostridioides difficile positive stool testing via GDH/EIA toxin testing at Screening Visit
• Received an investigational drug or vaccine within 3 months before study entry
• Received an FMT within the last 6 months
• Patients with anatomic or medical contraindications to colonoscopy, including but not necessarily limited to toxic megacolon, gastrointestinal (GI) fistulas, immediate postoperative status from abdominal surgery, severe coagulopathy, large or symptomatic abdominal aortic aneurysm, or any patient where study physician deems patient at significant risk of complications of colonoscopy
• Patients with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Crohn's and Colitis Center

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: September 1, 2023
• Primary Completion: November 21, 2024
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)