Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: TOP1288 Rectal solution
Pharmaceutical Form: Rectal solution
INN or Proposed INN: Not Applied for
CAS Number: 1630202-02-6
Sponsors
TOPIVERT Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects, 18 to 75 years of age, with a documented diagnosis of UC of at least 3 months duration prior to Screening, based on medical history, endoscopy, and (if available) histological findings. Eligible subjects will have a Partial Mayo Clinic Score of 4 to 8, consisting of all of the following: • Endoscopy subscore =2 (as per central read) • Rectal bleeding subscore =1 • Stool frequency subscore =1 • Disease activity extending at least 15 cm proximally from the anal verge In addition, eligible subjects: • Will be receiving a stable dose regimen of oral 5-aminosalicylic acid (5-ASA; =4.8 g/day) for at least 2 weeks prior to the Screening endoscopy, and be willing to continue the regimen for the duration of the study; or • If not currently receiving oral 5-ASA, must have received it previously and experienced a therapeutic failure or intolerance, or have a contraindication to aminosalicylates. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Receiving any rectally administered medication (i.e., any such medication, including topical corticosteroids and topical 5-ASA preparations must have been withdrawn at least 2 weeks prior to Screening endoscopy). 2. Use of biologic agents (including anti-tumor necrosis factor (TNF) agents and vedolizumab) within 3 months of Screening endoscopy. 3. Use of IV corticosteroids within 4 weeks prior to Screening endoscopy. 4. Use of oral corticosteroids at a dose >30 mg/day (or budesonide >9 mg/day). 5. In general, patients who have started receiving immune suppressants within 3 months of the Screening endoscopy should not be included. Patients on stable doses of the following medications for 3 months before the Screening endoscopy will be allowed: azathioprine, 6-mercaptopurine, or methotrexate. 6. Participated in another study of an investigational medication (or a medical device) within the last 3 months or 5 half-lives of the investigational medication, whichever is longer, or is currently participating in another study of an investigational medication (or a medical device). 7. Known hypersensitivity to any components of the IMP. 8. At Randomisation, a Partial Mayo Clinic Score of 9 (from the sum of the endoscopy subscore, rectal bleeding subscore, and stool frequency subscore) 9. Known or suspected pancolitis (unless on oral 5-ASA, steroids or permitted immunomodulators as described in the Section 5.8). 10. 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. 11. Extensive (>50%) colonic resection or colectomy, or prior history of toxic megacolon within 3 months of Screening. 12. History or presence of colonic mucosal dysplasia. Patients with dysplasia within a completely resected adenomatous polyp may be included. 13. Positive history of human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C. 14. Known history of and/or recent alcohol abuse that, in the opinion of the Investigator, could influence safety of patient participation in the study. 15. Any acute or chronic illness (other than UC) affecting the colon and/or rectum and/or anus 16. Any acute or chronic comorbidity, including cardiovascular, renal, hepatic, endocrine, pulmonary, or gastrointestinal, 17. Current evidence of or treatment for a malignancy within the past 3 years, other than localised basal-cell or squamous-cell skin cancer, cervical dysplasia, or carcinoma in situ that has been definitively treated with standard of care. 18. 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. 19. Patients testing positive of Clostridium difficile toxin or confirmed with bacterial or parasitical GI infections at Screening. 20. Patient has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study. 21. Any of the following h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the effect of TOP1288 200 mg Rectal Solution on endoscopic remission, as indicated by the Mayo Clinic modified endoscopic subscore, after 4 consecutive weeks of daily bedtime treatment; Secondary Objective: The secondary objectives of the study are to assess the effect of TOP1288 200 mg Rectal Solution on the following: • Assessment of safety, including AEs, vital signs, ECG, and laboratory test results (i.e., clinical chemistry, haematology, and urinalysis) • Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score • Partial Mayo Clinic score (i.e., the sum of the endoscopic, rectal bleeding, and stool frequency subscores) • Endoscopic healing (indicated by the Mayo Clinic modified endoscopic subscore) • Rectal bleeding (indicated by the Mayo Clinic rectal bleeding subscore) ; Primary end point(s): Primary Efficacy Endpoint: • Proportion of subjects achieving endoscopic remission (defined as a Mayo Clinic modified endoscopy subscore of 0 or 1) at Week 4 ;Timepoint(s) of evaluation of this end point: at Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Change from Baseline to Week 4; Secondary end point(s): Secondary Efficacy Endpoint(s): Change from Baseline to Week 4 in: • UCEIS score • Partial Mayo Clinic score (the sum of endoscopic, rectal bleeding, and stool frequency subscores) • Proportion of subjects with endoscopic healing (defined as a Mayo Clinic modified endoscopic subscore of 0) • Proportion of subjects with an improvement in Mayo Clinic rectal bleeding subscore of =1 | — |
Countries
Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Poland, Ukraine, United Kingdom
Contacts
Public ContactHead of Clinical Development
TOPIVERT Pharma Limited
Outcome results
None listed