CP101 for the Treatment of Ulcerative Colitis

Korábbi kezelés

• Antibiotic use within the prior 1 month before randomization
• Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment
• 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)
• Unable to complete appropriate washout periods/stop prior therapies, as defined in Section 5.3
• Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor)

Más betegség

• Disease limited to distal proctitis
• 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 active malignancy except for basal cell skin cancer, squamous cell skin cancer
• 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

Egyéb

• Severe or refractory UC defined as Mayo score ≥10
• Fever > 38.3°C
• Known or suspected toxic megacolon and/or known small bowel ileus
• Patients with active intestinal obstruction
• Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
• Clostridioides difficile positive stool testing via GDH/EIA toxin testing at Screening Visit
• Patients with known diagnosis primary or secondary immune deficiency e.g., IgA deficiency, SCID, CGD

• 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