drugset / Trial / NCT03681067
A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease
Phase 1/2
Completed
5 enrolled
University of Birmingham
GlaxoSmithKline · collabUniversity Hospital Birmingham · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial aims to investigate the safety, tolerability and clinical activity of humanised antibody GSK1070806 delivered via intravenous infusion in the treatment of patients with moderate-to-severe Crohn's disease. 30-36 patients will be enrolled into the trial, with two thirds of the patients receiving active drug and one third receiving placebo. After 30 patients have been recruited into the study the sample size will be reassessed and up to an additional 6 patients could be recruited (i.e. up to 36 patients).
Timeline
- Start
- 2019-02-20
- Primary completion
- 2020-06-02
- Completion
- 2020-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK1070806 | Monoclonal antibody | 100 mg/ml | Intravenous |