Clinical Trial: Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.

Detailed Summary:

The study has been amended accordingly in February 2016 to further allow for the enrollment of a subgroup of subjects (N=60) who will be allowed to receive treatment with approved IPF therapy with pirfenidone or with nintedanib as background therapy.

These additional subjects will be stratified by background therapy, randomized to FG-3019 or placebo and followed up for 24 weeks. The main objective of the study remains safety. PK samples to assess drug concentrations will also be collected.

(This substudy portion only applies to US and Canadian centers.)

Enrollment for the main study was completed on 29Jun2016 Enrollment for the sub-study was completed on 16Dec2016


Sponsor: FibroGen

Current Primary Outcome: Change from baseline in FVC (percent of predicted value) at Week 48. [ Time Frame: Day 1 to Week 48 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in pulmonary fibrosis score by quantitative HRCT at Week 24, Week 48, and later time points. [ Time Frame: Week 24, Week 48, and later time points ]
  • Change from baseline in HRQoL [ Time Frame: Week 24, Week 48, and later time points ]
  • Time to progression of IPF, defined as time from Day 1 to any one of the following [ Time Frame: Day 1 to anyone of the following below: ]
    1. Death from any cause.
    2. Absolute decline in FVC % of predicted value of ≥10% not due to intercurrent illness, confirmed by repeat spirometry.
    3. Clinical diagnosis of IPF progression.
    4. Absolute decline in DLCO, adjusted for Hgb, percent of predicted value of ≥15%.
  • Proportion of subjects with at least one respiratory-related hospitalization [ Time Frame: Week 55 ]
  • Proportion of subjects with respiratory-related death, censored at Week 55. [ Time Frame: Week 55 ]
  • Categorical assessment of absolute change from baseline in FVC percent of predicted value at Week 48 [ Time Frame: Week 48 ]


Original Secondary Outcome:

  • Change from baseline in health-related quality of life at Week 48. [ Time Frame: Day 1 to Week 48 ]
  • Change from baseline in subject-reported dyspnea at Week 48. [ Time Frame: 48 weeks ]
  • Time to progression of IPF, defined as time from Day 1 to any one of the following [ Time Frame: Day 1 to anyone of the following below: ]
    1. First respiratory-related hospitalization.
    2. Respiratory-related death.
    3. Absolute decline in FVC percent of predicted value of ≥10%.
    4. Absolute decline in DLCO, adjusted for Hgb, percent of predicted value of ≥15%.
  • Proportion of subjects with at least one respiratory-related hospitalization [ Time Frame: Week 52 ]
  • Proportion of subjects with respiratory-related death, censored at Week 52. [ Time Frame: Week 52 ]
  • Categorical assessment of absolute change from baseline in FVC percent of predicted value at Week 48 [ Time Frame: Week 48 ]
  • Change from baseline to Week 48 in computer-assisted scores of percent of area of lung parenchymal fibrosis [ Time Frame: Baseline to Week 48 ]


Information By: FibroGen

Dates:
Date Received: June 24, 2013
Date Started: June 2013
Date Completion: July 2017
Last Updated: February 8, 2017
Last Verified: February 2017