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