NCT01890265

Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these participants.

Detailed description

The study has been amended in February 2016 to further allow for the enrollment of a subgroup of participants (N=60) who will be allowed to receive treatment with approved IPF therapy with pirfenidone or with nintedanib as concomitant therapy. These additional participants will be stratified by background therapy, randomized to pamrevlumab or placebo, and followed up for 24 weeks. The main objective of the study remains safety. Pharmacokinetic (PK) samples to assess drug concentrations will also be collected. This sub-study portion only applies to a select United States centers. Enrollment for the main study was completed on 29 June 2016. Enrollment for the sub-study was completed on 16 December 2016.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Pamrevlumab	Solution for infusion
DRUG	Placebo	Solution for infusion
DRUG	Sub-Study: Pirfenidone	Pirfenidone concomitant therapy will not be provided by the Sponsor.
DRUG	Sub-Study: Nintedanib	Nintedanib concomitant therapy will not be provided by the Sponsor.

Timeline

• Start date: 2013-07-30
• Primary completion: 2017-11-16
• Completion: 2017-11-16
• First posted: 2013-07-01
• Last updated: 2020-09-04
• Results posted: 2020-09-04

Locations

42 sites across 7 countries: United States, Australia, Bulgaria, Canada, India, New Zealand, South Africa