CP101 for the Treatment of Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

Criteria

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 prior to randomization into the study. (flexible sigmoidoscopy permitted if subject has had a full colonoscopy within 12 months of baseline)

5. 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.)

6. Disease at least 15 cm from anal verge

7. Stable dosing of concomitant medication

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, gastric outlet 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 30 days before enrollment

11. Clostridioides difficile positive stool testing via GDH/EIA toxin testing at Screening 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 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

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 in Section 5.3

17. Patients with known diagnosis primary or secondary immune deficiency e.g., IgA deficiency, 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 for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor)

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