Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis

• Status: Completed
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topivert Pharma Ltd
• Treatments: Pharmaceutical Solutions

Criteria

Key Inclusion Criteria:

• Diagnosis of UC of at least 3 months duration

• Active UC with a Partial Mayo Clinic Score of 4 to 8 at randomization

Key Exclusion Criteria:

• Receiving any rectally administered medication

• Use of biologic agents within 3 months prior to Screening endoscopy

• Use of IV corticosteroids within 4 weeks prior to Screening endoscopy

• Use of oral corticosteroids at a dose >30 mg/day (or budesonide >9 mg/day).

• Patients who have started receiving immune suppressants within 3 months of the Screening endoscopy should not be included.

• Known or suspected pancolitis (unless on oral 5-ASA, steroids or permitted immunomodulators)

• Known or suspected Crohn's disease, indeterminate colitis, microscopic colitis, ischaemic colitis, or radiation-induced colitis, based on medical history, endoscopy, and/or histological findings

• Extensive (>50%) colonic resection or colectomy, or prior history of toxic megacolon within 3 months of Screening

• Patient has active serious infection (e.g., sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalisation or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration

• Patients testing positive of Clostridium difficile toxin or confirmed with bacterial or parasitical GI infections at Screening