Crohn's Disease
Conditions
Interventions
Study sites Colombo North Teaching Hospital, Ragama Teaching Hospital Karapitiya, Galle Kandy Teaching Hospital, Kandy, Teaching Hospital, Kurunegala, National Hospital of Sri Lanka
This is a combine
Sponsors
Gilead Sciences, Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit 2. Documented diagnosis of Crohn's disease (CD) with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment 3. Moderately to severely active Crohn's disease (CD) as determined by a) CDAI total score between 220 and 450 inclusive b) PRO2 score consisting of abdominal pain >2 (on CDAI scale of 0 to 3) OR daily stool frequency >4 c) Evidence of active disease as measured by SES-CD, (Total score >6, OR If disease is limited to the ileum and/or right colon, a combined score >4 in these two segments) 4. Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents: corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Exclusion criteria
Exclusion criteria: 1. Current complications of Crohn's disease (CD) such as symptomatic strictures, severe rectal/anal stenosis, fistulae, short bowel syndrome, etc. 2. Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon 3. Active tuberculosis (TB) or history of latent TB that has not been treated 4. Use of any prohibited concomitant medications as described in the study protocol (details available at the SLCTR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction Study: 1. Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 2. Proportion of Participants Achieving Endoscopic Response at Week 10 Maintenance Study: 1. Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 2. Proportion of Participants Achieving Endoscopic Response at Week 58 [Induction Study: 1. Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ] 2. Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ] Maintenance Study: 3. Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ] 4. Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 ]] | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction Study: 1. Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 2. Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at Week 10 (Composite Endpoint) 3. Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 Maintenance Study: 4. Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 5. Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58 6. Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic Response at Week 58 (Composite Endpoint) 7. Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 8. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [Induction Study 1. Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ] 2. Proportion of Participants Achieving Both Clinical Remission by PRO2 and endoscopic response at Week 10 (Composite Endpoint) [ Time Frame: Week 10 ] 3. Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ] Maintenance Study: 4. Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 [ Time Frame: Week 58 ] 5. Proportion of Participants Achieving Sustained Clinical Remission by PRO2 at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ] 6. Proportion of Participants Achieving Both Clinical Remission by PRO2 and Endoscopic Response at Week 58 (Composite Endpoint) [ Time Frame: Week 58 ] 7. Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 [ Time Frame: Week 58 ] 8. Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]] | — |
Countries
Australia,Austria,Belgium,Bulgaria,Canada,Croatia,Czech Republic,France,Georgia,Germany,Greece,Hong Kong,Hungary,Iceland,India,Ireland,Israel,Italy,Japan,Korea, Republic of,Malaysia,Mexico,Netherlands
Contacts
Public ContactProf Arjuna de Silva
Consultant Physician
Outcome results
None listed