Mild-to-moderate active ulcerative colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Code: GB004
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not applicable
CAS Number: 1303513-80-5
Current Sponsor code: GB004
Other descriptive name: GB004-HCl
Concentration uni
Sponsors
GB004, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Adult male and female subjects aged = 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. o UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1. o Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following treatments: a. prednisone = 20 mg/day or equivalent or b. beclomethasone = 5 mg/day or c. budesonide or budesonide multi-matrix (MMX) of = 9 mg/day 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 195 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Prior approved biologic therapy used for the treatment of UC. o Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection. o Tofacitinib, oral cyclosporine, sirolimus or myocophenolate mofetil within 8 weeks of Day 1. o Azathioprine, or 6-mercaptopurine within 1 day of Day 1. o Diagnosis of Crohn's disease or indeterminate colitis, pouchitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of GB004 compared to placebo on clinical remission at PCP Week 12;Secondary Objective: o To evaluate the effect of GB004 on clinical response, histologic remission, endoscopic improvement and mucosal healing at PCP Week 12 o To evaluate the effect of GB004 on clinical remission, clinical response, histologic remission, endoscopic improvement, and mucosal healing at PCP Week 36;Primary end point(s): Proportion of subjects with clinical remission at PCP Week 12, defined as a Modified Mayo score = 2, with a Rectal bleeding subscore of 0, Stool frequency subscore of 0 or 1 (with a = 1 point decrease from baseline), and Endoscopic subscore of 0 or 1;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects with clinical response at PCP Week 12, defined as reduction in the Modified Mayo score of = 2 points and = 35 percent reduction from baseline, including a decrease in Rectal bleeding subscore of =1 or absolute Rectal bleeding subscore of = 1 2. Proportion of subjects with histologic remission at PCP Week 12, defined as Robarts Histopathology Index (RHI) = 3 with lamina propria neutrophils subscore = 0 and neutrophils in epithelium subscore = 0 3. Proportion of subjects with endoscopic improvement at PCP Week 12, defined as endoscopic subscore of 0 or 1 4. Proportion of subjects with mucosal healing at PCP Week 12, defined as endoscopic improvement and histologic remission 5. Proportion of subjects with clinical remission at PCP Week 36 6. Proportion of subjects with clinical response at PCP Week 36 7. Proportion of subjects with histologic remission at PCP Week 36 8. Proportion of subjects with endoscopic improvement at PCP Week 36 9. Proportion of subjects with mucosal healing at PCP Week 36;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Australia, Belarus, Georgia, Italy, Korea, Republic of, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactClinical Trials Information Website
GB004, Inc.
Outcome results
None listed