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

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

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.

Sponsors & Collaborators

• FibroGen

  lead INDUSTRY

Principal Investigators

• Mark Wencel, M.D · Via Christi Clinic, P.A., USA

• Joao de Andrade, M.D · The Kirklin Clinic, USA

• Peter LaCamera, M.D. · Steward St. Elizabeth's Medical Center, USA

• Danielle Antin-Ozerkis, M.D. · Yale University, USA

• Rishi Raj, M.D. · Northwestern University

• Neil Ettinger, M.D · St Luke's Hospital, USA

• Rafael Perez, M.D · University of Louisville, USA

• Timothy Albertson, M.D · University of California Davis Medical Center, USA

• Yolanda Mageto, M.D. · Vermont Lung Center, USA

• Srihari Veeraraghavan, M.D · Emory University, USA

• Nishant Gupta, M.D · University of Cinncinati, USA

• Kevin Gibson, M.D · University of Pittsburgh Medical Center, USA

• Lisa Lancaster, M.D. · Vanderbilt University, USA

• Mary Beth Scholand, M.D. · University of Utah - Lung Health Research, USA

• Mark Hamblin, M.D. · University of Kansas Medical Center, USA

• John Fitzgerald, M.D. · University of Texas Southwestern Medical Center, USA

• John Belperio, M.D. · David Geffen School of Medicine at UCLA, USA

• Richard Enelow, M.D. · Dartmouth-Hitchcock Medical Center, USA

• Evans R Fernandez-Perez, M.D · National Jewish Center, USA

• Peter A Bercz, M.D · Pensacola Research Consultants, INC., USA

• Krishna Thavarajah, M.D. · Henry Ford Medical Center, USA

• James Britt, M.D. · University of Maryland, College Park

• Danielle D. Hosmer · Legacy Research Institute, USA

• David Lederer, M.D. · Columbia University Medical Center, USA

• Murali Ramaswamy, M.D. · PulmonIx LLC, USA

• Thomas O'Brien, M.D. · Pulmonary Disease Specialist, PA, USA

• Nadim Srour, M.D. · Université de Sherbrooke / Hôpital Charles LeMoyne, Canada

• Elvis Irusen, M.D. · Tygerberg Hospital Respiratory Research Unit, South Africa

• Anish Ambaram, M.D. · Life Mount Edgecombe Hospital, South Africa

• Heidi Siebert, M.D. · Into Research, South Africa

• Elizabeth Veitch, M.D. · Concord Repatriation, Australia

• Huw Davies, M.D. · Daw Park Repatriation, Australia

• Lutz Beckert, M.D. · Christchurch Hospital NZ, New Zealand

• Catherina Chang, M.D. · Waikato Hospital, New Zealand

• Benedict Brockway, M.D. · Dunedin Public Hospital, New Zealand

• Suzanne Poole, M.D. · Tauranga Hospital, New Zealand

• Raja Dhar, M.D. · Fortis Hospitals, India

• Bhanu Singh, M.D. · Midland Healthcare & Research Center, India

• Nandagopal Velayuthaswamy, M.D. · Sri Bala Medical Centre and Hospital, India

• Sujeet Rajan, M.D. · Bhatia Hospital, India

• Priya Ramachandran, M.D. · St Johns Medical College Hospital, India

• Natalia Stoeva, M.D. · MHAT 'Tokuda Hospital Sofia', AD, Department of Pulmonology, Bulgaria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-30

Primary Completion

2017-11-16

Completion

2017-11-16

Countries

• United States
• Australia
• Bulgaria
• Canada
• India
• New Zealand
• South Africa

Study Locations