Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Code: PN-943
Pharmaceutical Form: Tablet
Current Sponsor code: PN-943
Other descriptive name: PN-943
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Ph
Sponsors
Protagonist Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years. 2. Diagnosis of UC for = 8 weeks prior to screening supported by appropriate documentation of biopsy results consistent with UC. 3. Moderate to severe active UC 4. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biological. See protocol for further inclusion criteria 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 152 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: 1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis. 2. History of colonic dysplasia (other than completely removed low-grade dysplastic lesion). 3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/antiinfectives within 2 weeks of screening. 4. Positive stool test for C. difficile. 5. Chronic recurrent or serious infection. 6. Known primary or secondary immunodeficiency. 7. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication. See protocol for further exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate safety, tolerability and efficacy of PN-943 treatment in subjects with moderate to severe active ulcerative colitis compared to placebo.;Secondary Objective: Evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and biomarker responses to PN-943 in subjects with moderate to severe active ulcerative colitis.;Primary end point(s): Efficacy Proportion of subjects achieving clinical remission at Week 12 compared to placebo.;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Comparison of PN-943 high dose, low dose and individually to placebo: a) Proportion of subjects with endoscopic improvement at Week 12. b) Proportion of subjects achieving endoscopic remission at Week 12. c) Proportion of subjects with histological improvement at Week 12. d) Proportion of subjects achieving histological remission at Week 12. • Proportion of subjects achieving clinical remission at Week 52. Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): - Stool frequency subscore (SFS) - Rectal bleeding subscore (RBS) - Endoscopic subscore (ESS);Timepoint(s) of evaluation of this end point: Week 12 and Week 52 | — |
Countries
Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Korea, Republic of, Poland, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactClinical-Regulatory Info Group
Protagonist Therapeutics, Inc.
Outcome results
None listed