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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02888379
• Date of registration: 30/08/2016
• Prospective Registration: Yes
• Primary sponsor: Topivert Pharma Ltd
• Public title: Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis TOP2
• Scientific title: 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
• Date of first enrolment: September 2016
• Target sample size: 77
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02888379
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Czech Republic, Czechia, Hungary, Latvia, Lithuania, Poland, Ukraine, United Kingdom

Contacts

• Name: Simon Travis, FRCP
• Affiliation: Oxford University Hospitals Trust, John Radcliffe Hospital, Oxford, UK,

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: TOP1288

Drug: Placebo (for TOP1288)

Primary Outcome(s)

Efficacy as measured by the Mayo Clinic modified endoscopic subscore [Time Frame: After 4 consecutive weeks of daily bedtime treatment]

Secondary Outcome(s)

Efficacy as measured by rectal bleeding (indicated by the Mayo Clinic rectal bleeding subscore) [Time Frame: After 4 consecutive weeks of daily bedtime treatment]

Efficacy as measured by endoscopic healing (indicated by the Mayo Clinic modified endoscopic subscore) [Time Frame: After 4 consecutive weeks of daily bedtime treatment]

Efficacy as measured by Partial Mayo Clinic score (i.e., the sum of the endoscopic, rectal bleeding, and stool frequency subscores) [Time Frame: After 4 consecutive weeks of daily bedtime treatment]

Safety as measured by adverse events [Time Frame: To 1 week after the last dose]

Safety as measured by ECGs [Time Frame: To 1 week after the last dose]

Efficacy as measured by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score [Time Frame: After 4 consecutive weeks of daily bedtime treatment]

Safety as measured by vital signs [Time Frame: To 1 week after the last dose]

Safety as measured by clinical laboratory tests [Time Frame: To 1 week after the last dose]

Secondary ID(s)

TOP1288-TV-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors