drugset / Trial / NCT02759562

Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

NCT02759562

Phase 2 Terminated 6 enrolled Gilead Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the effect of andecaliximab (GS-5745) on pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted in adults with cystic fibrosis (CF) after 8 weeks of treatment. There will be 2 parts to this study. In Part 1, andecaliximab 600 mg or placebo will be administered for 8 weeks. In Part 2, andecaliximab 300 mg, 150 mg, or placebo will be administered for 8 weeks. Part 2 will be initiated after completion of Part 1.

Timeline

Start
2016-11-04
Primary completion
2017-07-06
Completion
2017-07-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Andecaliximab Monoclonal antibody 150 mg Subcutaneous
Subject Andecaliximab Monoclonal antibody 300 mg Subcutaneous
Subject Andecaliximab Monoclonal antibody 600 mg Subcutaneous

Indications