CP101 for the Treatment of Ulcerative Colitis

Last updated: December 4, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Not Recruiting

Phase

1

Condition

Ulcerative Colitis

Ulcers

Inflammatory Bowel Disease

Treatment

CP-101 + Placebo

CP-101

Clinical Study ID

NCT05852574
2023P001470
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent

  2. Male or female ≥18 years of age

  3. Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic criteria

  4. Active mild-moderate UC as determined by colonoscopy approximately 10-21 days priorto randomization into the study. (flexible sigmoidoscopy permitted if subject hashad a full colonoscopy within 12 months of baseline)

  5. Mild-moderate UC, defined by a complete Mayo score to include: the sum of rectalbleeding, stool frequency, endoscopic findings and physician global assessmentsub-scores totaling ≥4 and ≤9, with each individual sub-group score ≥1.)

  6. Disease at least 15 cm from anal verge

  7. Stable dosing of concomitant medication

Exclusion

Exclusion Criteria:

  1. Severe or refractory UC defined as Mayo score ≥10

  2. Disease limited to distal proctitis

  3. Fever > 38.3°C

  4. Known history of Crohn's disease or indeterminate colitis

  5. Inability to ingest capsules (e.g., severe nausea, vomiting, gastroparesis, gastricoutlet obstruction, dysphagia and/or history of chronic aspiration).

  6. Known or suspected toxic megacolon and/or known small bowel ileus

  7. Patients with active intestinal obstruction

  8. Antibiotic use within the prior 1 month before randomization

  9. Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)

  10. Known stool studies positive for ova and/or parasites or stool culture within the 30days before enrollment

  11. Clostridioides difficile positive stool testing via GDH/EIA toxin testing atScreening Visit

  12. Received an investigational drug or vaccine within 3 months before study entry

  13. Received an FMT within the last 6 months

  14. Patients with anatomic or medical contraindications to colonoscopy, including butnot necessarily limited to toxic megacolon, gastrointestinal (GI) fistulas,immediate postoperative status from abdominal surgery, severe coagulopathy, large orsymptomatic abdominal aortic aneurysm, or any patient where study physician deemspatient at significant risk of complications of colonoscopy

  15. Patients with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)

  16. Unable to complete appropriate washout periods/stop prior therapies, as defined inSection 5.3

  17. Patients with known diagnosis primary or secondary immune deficiency e.g., IgAdeficiency, SCID, CGD

  18. Known active malignancy except for basal cell skin cancer, squamous cell skin cancer

  19. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment foractive malignancy (patients on maintenance chemotherapy may only be enrolled afterconsultation with medical monitor)

  20. Patients with any other significant medical condition that could confound orinterfere with the evaluation of safety, tolerability or prevent compliance with thestudy protocol at the discretion of the investigator

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: CP-101 + Placebo
Phase: 1
Study Start date:
September 01, 2023
Estimated Completion Date:
June 02, 2025

Study 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 score<=1) performed during screening.

Participants who meet eligibility criteria will be randomized 1:1 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 participant's 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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