Crohn’s Disease and an Ileostomy
Conditions
Brief summary
Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.
Detailed description
Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs since week12 to week 52., a) Change from baseline in endoscopic score (SES CD using endoscopic assessment) at Week 12. b) Change from baseline in endoscopic score (MM SES-CD) at Week 12. c) Endoscopic response (≥ 50% decrease from baseline in SES-CD total score) at Week 12. d) Endoscopic remission (SES-CD total score < 4 and at least 2‑point reduction from baseline with no subscore > 1 in any individual variable) at Week 12., a) Serum AZD7798 concentration. b) Incidence and titre of ADA response
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs since week12 to week 52., a) Change from baseline in endoscopic score (SES CD using endoscopic assessment) at Week 12. b) Change from baseline in endoscopic score (MM SES-CD) at Week 12. c) Endoscopic response (≥ 50% decrease from baseline in SES-CD total score) at Week 12. d) Endoscopic remission (SES-CD total score < 4 and at least 2‑point reduction from baseline with no subscore > 1 in any individual variable) at Week 12., a) Serum AZD7798 concentration. b) Incidence and titre of ADA response | — |
Countries
Belgium, Italy, Netherlands, Poland, Sweden
Outcome results
None listed