NCT02759562

Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis

A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Andecaliximab	Administered via subcutaneous injection
DRUG	Placebo	Administered via subcutaneous injection

Timeline

• Start date: 2016-11-04
• Primary completion: 2017-07-06
• Completion: 2017-07-21
• First posted: 2016-05-03
• Last updated: 2018-08-17
• Results posted: 2018-07-05

Locations

5 sites across 5 countries: Australia, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study