Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Sponsors
Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are required to meet the following criteria in order to be included in the study: - Male or female =18 years of age - Subjects must have had a diagnosis of UC at least 3 months before Randomization (confirmed by endoscopy + histology) to be eligible for study participation - Moderately to severely active UC - Subjects must have had insufficient response and/or intolerance to conventional therapy - For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug - Male subjects must use, with their female partner of childbearing potential, two highly effective methods of contraception and refrain from sperm donation from screening to 12 weeks after the last dose of study drug - Subject must meet concomitant medication stabilization requirements, as applicable - Able to provide written informed consent and understand and comply with the requirements of the study 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 146 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: - WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception - Women who are pregnant or breastfeeding - Women with a positive pregnancy test - Diagnosis of Crohn's disease or indeterminate colitis - UC limited to the rectum (<15 cm from anal verge) - Current evidence of fulminant colitis, toxic megacolon, or bowel perforation - Current or impending need for colostomy or ileostomy - Previous total proctocolectomy or partial colectomy - Surgical bowel resection within 3 months before screening - Concomitant primary sclerosing cholangitis (PSC) - Past or current evidence of colonic dysplasia that has not been completely removed - Scheduled or anticipate the need for surgery, except dermatologic procedures - History of clinically significant drug or alcohol abuse - Prior exposure to PRA023 - Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness must not be enrolled into this study - Legal or mental incapacitation, or inability to understand and comply with the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety and tolerability of PRA023 following 12-weeks of induction therapy 2. To compare the efficacy of PRA023 vs placebo for induction of clinical remission at Week 12 ;Secondary Objective: Compare the efficacy of PRA023 vs placebo for induction of: - endoscopic improvement - clinical response - symptomatic remission - histologic remission - histologic-endoscopic mucosal improvement - mucosal healing Compare the efficacy of PRA023 vs placebo for change in IBDQ Compare the efficacy of PRA023 vs placebo in subjects who are companion diagnostic positive (CDx+) for induction of: - clinical remission - endoscopic improvement - clinical response - histologic remission - histologic-endoscopic mucosal improvement - mucosal healing Compare the efficacy of PRA023 vs placebo in subjects who are CDx + per alternative alternative algorithm for induction of clinical remission at Week 12 Compare the efficacy of PRA023 in CDx + vs CDx negative (CD x - ) subjects for induction of clinical remission at Week 12 Compare the efficacy of PRA023 vs placebo in CDx + subjects for change in IBDQ at Week 12;Primary end point(s): 1. The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values. 2. The proportion of subjects in clinical remission at Week 12. ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of subjects with endoscopic improvement at Week 12. 2. The proportion of subjects in clinical response at Week 12. 3. The proportion of CDx+ subjects in clinical remission. 4. The proportion of subjects in symptomatic remission at Week 12. 5. The proportion of subjects with histologic remission at Week 12. 6. The proportion of subjects with histologic-endoscopic mucosal improvement at Week 12. 7. The proportion of CDx+ subjects with endoscopic improvement at Week 12. 8. The proportion of CDx+ subjects in clinical response at Week 12. 9. The proportion of subjects with symptomatic remission treated with PRA023 compared to CDx + placebo-treated subjects at Week 12. 10. The proportion of CDx + subjects with histologic remission at Week 12. 11. The proportion of CDx+ subjects with histologic-endoscopic mucosal improvement at Week 12. 12. The proportion of CDx+ subjects with clinical remission Week 12. 13. The proportion of subjects with mucosal healing at Week 12. 14. The proportion of CDx+ subjects with mucosal healing at Week 12. 15. The proportion of subjects with IBDQ response at Week 12. 16. The proportion of CDx+ subjects with IBDQ response at Week 12. 17. The proportion of CDx+ subjects (per alternative algorithm) in clinical remission at Week 12.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Australia, Belgium, Canada, Czechia, Czech Republic, France, Georgia, Hungary, Italy, Poland, United Kingdom, United States
Contacts
Public ContactClinical Operations
Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.
Outcome results
None listed