Phase
Condition
Ulcerative Colitis
Ulcers
Inflammatory Bowel Disease
Treatment
CP-101 + Placebo
CP-101
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 priorto randomization into the study. (flexible sigmoidoscopy permitted if subject hashad a full colonoscopy within 12 months of baseline)
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.)
Disease at least 15 cm from anal verge
Stable dosing of concomitant medication
Exclusion
Exclusion Criteria:
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, gastricoutlet 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 30days before enrollment
Clostridioides difficile positive stool testing via GDH/EIA toxin testing atScreening 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 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
Patients with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)
Unable to complete appropriate washout periods/stop prior therapies, as defined inSection 5.3
Patients with known diagnosis primary or secondary immune deficiency e.g., IgAdeficiency, SCID, CGD
Known active malignancy except for basal cell skin cancer, squamous cell skin cancer
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment foractive malignancy (patients on maintenance chemotherapy may only be enrolled afterconsultation with medical monitor)
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
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
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