A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity
- Conditions
- Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivityMedDRA version: 19.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-000390-20-LV
- Lead Sponsor
- TOPIVERT Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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 (required of all subjects in the Czech Republic); 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 (applies to subjects in all participating countries except the Czech Republic).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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medication (i.e., any such medication, including topical corticosteroids and topical 5-ASA preparations must have been withdrawn at least 2 weeks prior to Screening endoscopy).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-tumour necrosis factor [TNF] agents and vedolizumab) within 3 months of Screening endoscopy, or 5 half-lives, whichever is longer.
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 for Clostridium difficile toxin or confirmed with bacterial or parasitical GI infections at Screening. Patients who test positive for C difficile antigen or who test positive for Blastocystis hominis may be eligible based on the judgment of the Investigator and local practice.
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 haematology values at Screening :
• Absolute neutrophil count <1.0 x 10^9/L (<1000/µL)
• Haemoglobin <8.5 g/dL
• Absolut
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method