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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01890265 |
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Date of registration:
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24/06/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific title:
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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July 30, 2013 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01890265 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Bulgaria
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Canada
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India
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New Zealand
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South Africa
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United States
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Contacts
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Name:
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Sujeet Rajan, M.D. |
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Affiliation:
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Bhatia Hospital, India |
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Name:
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Anish Ambaram, M.D. |
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Affiliation:
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Life Mount Edgecombe Hospital, South Africa |
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Name:
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Peter LaCamera, M.D. |
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Affiliation:
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Steward St. Elizabeth's Medical Center, USA |
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Name:
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Suzanne Poole, M.D. |
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Affiliation:
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Tauranga Hospital, New Zealand |
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Name:
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Lisa Lancaster, M.D. |
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Affiliation:
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Vanderbilt University, USA |
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Name:
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Mark Wencel, M.D |
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Affiliation:
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Via Christi Clinic, P.A., USA |
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Name:
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Natalia Stoeva, M.D. |
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Affiliation:
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MHAT 'Tokuda Hospital Sofia', AD, Department of Pulmonology, Bulgaria |
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Name:
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Nadim Srour, M.D. |
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Affiliation:
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Université de Sherbrooke / Hôpital Charles LeMoyne, Canada |
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Name:
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Nishant Gupta, M.D |
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Affiliation:
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University of Cinncinati, USA |
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Name:
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Huw Davies, M.D. |
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Affiliation:
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Daw Park Repatriation, Australia |
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Name:
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Evans R Fernandez-Perez, M.D |
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Affiliation:
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National Jewish Center, USA |
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Name:
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Rishi Raj, M.D. |
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Affiliation:
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Northwestern University |
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Name:
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Mark Hamblin, M.D. |
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Affiliation:
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University of Kansas Medical Center, USA |
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Name:
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James Britt, M.D. |
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Affiliation:
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University of Maryland, College Park |
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Name:
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Lutz Beckert, M.D. |
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Affiliation:
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Christchurch Hospital NZ, New Zealand |
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Name:
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Benedict Brockway, M.D. |
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Affiliation:
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Dunedin Public Hospital, New Zealand |
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Name:
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Krishna Thavarajah, M.D. |
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Affiliation:
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Henry Ford Medical Center, USA |
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Name:
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Bhanu Singh, M.D. |
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Affiliation:
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Midland Healthcare & Research Center, India |
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Name:
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Kevin Gibson, M.D |
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Affiliation:
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University of Pittsburgh Medical Center, USA |
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Name:
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John Belperio, M.D. |
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Affiliation:
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David Geffen School of Medicine at UCLA, USA |
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Name:
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Raja Dhar, M.D. |
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Affiliation:
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Fortis Hospitals, India |
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Name:
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Heidi Siebert, M.D. |
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Affiliation:
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Into Research, South Africa |
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Name:
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Mary Beth Scholand, M.D. |
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Affiliation:
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University of Utah - Lung Health Research, USA |
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Name:
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Srihari Veeraraghavan, M.D |
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Affiliation:
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Emory University, USA |
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Name:
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Peter A Bercz, M.D |
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Affiliation:
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Pensacola Research Consultants, INC., USA |
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Name:
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Thomas O'Brien, M.D. |
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Affiliation:
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Pulmonary Disease Specialist, PA, USA |
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Name:
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Rafael Perez, M.D |
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Affiliation:
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University of Louisville, USA |
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Name:
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David Lederer, M.D. |
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Affiliation:
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Columbia University Medical Center, USA |
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Name:
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Murali Ramaswamy, M.D. |
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Address:
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Affiliation:
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PulmonIx LLC, USA |
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Name:
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Elvis Irusen, M.D. |
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Affiliation:
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Tygerberg Hospital Respiratory Research Unit, South Africa |
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Name:
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Timothy Albertson, M.D |
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Affiliation:
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University of California Davis Medical Center, USA |
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Name:
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Yolanda Mageto, M.D. |
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Affiliation:
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Vermont Lung Center, USA |
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Name:
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Danielle Antin-Ozerkis, M.D. |
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Affiliation:
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Yale University, USA |
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Name:
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Elizabeth Veitch, M.D. |
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Address:
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Affiliation:
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Concord Repatriation, Australia |
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Name:
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Richard Enelow, M.D. |
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Address:
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Affiliation:
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Dartmouth-Hitchcock Medical Center, USA |
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Name:
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Danielle D. Hosmer |
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Affiliation:
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Legacy Research Institute, USA |
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Name:
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Nandagopal Velayuthaswamy, M.D. |
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Affiliation:
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Sri Bala Medical Centre and Hospital, India |
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Name:
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Priya Ramachandran, M.D. |
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Affiliation:
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St Johns Medical College Hospital, India |
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Name:
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Neil Ettinger, M.D |
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Affiliation:
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St Luke's Hospital, USA |
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Name:
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Joao de Andrade, M.D |
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Affiliation:
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The Kirklin Clinic, USA |
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Name:
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John Fitzgerald, M.D. |
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Address:
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Affiliation:
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University of Texas Southwestern Medical Center, USA |
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Name:
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Catherina Chang, M.D. |
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Affiliation:
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Waikato Hospital, New Zealand |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 40 to 80 years, inclusive.
2. Diagnosis of IPF as defined by current international guidelines. Each participant must
have 1 of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an
available high-resolution computed tomography (HRCT) scan; or (2) Possible UIP Pattern
on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing
UIP Pattern.
3. History of IPF of =5 years duration with onset defined as the date of the first
diagnosis of IPF by HRCT or surgical lung biopsy.
4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of
=10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the
whole lung, as determined by the HRCT central reader.
5. FVC percent of predicted value =55% at Screening.
6. Female participants of childbearing potential (including those <1 year postmenopausal)
must be willing to use a medically acceptable method of contraception, for example, an
oral contraceptive, depot progesterone, or intrauterine device. Male participants with
female partners of childbearing potential who are not using birth control as described
above must use a barrier method of contraception (for example, condom) if not
surgically sterile (for example, vasectomy).
7. For sub-study only: Receiving treatment for IPF with a stable dose of pirfenidone or
with a stable dose of nintedanib for at least 3 months before Screening initiation and
willing to continue treatment with pirfenidone or with nintedanib according to the
corresponding approved label and the prescribing physician, including all listed
safety requirements (for example, liver function tests, avoidance of sunlight and
sunlamp exposure and wearing of sunscreen and protective clothing daily for
pirfenidone, and smoking cessation).
Exclusion Criteria:
1. Women who are pregnant or nursing.
2. Infiltrative lung disease other than IPF, including any of the other types of
idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure
to fibrogenic agents or other environmental toxins or drugs; other types of
occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases;
systemic diseases, including vasculitis and connective tissue diseases.
3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by
the HRCT central reader.
4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as
determined by the local pathologist.
5. The Investigator judges that there has been sustained improvement in the severity of
IPF during the 12 months prior to Screening, based on changes in FVC, diffusing
capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.
6. Clinically important abnormal laboratory tests.
7. Upper or lower respiratory tract infection of any type within 4 weeks of the first
Screening visit.
8. Acute exacerbation of IPF within 3 months of the first Screening visit.
9. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal
antibodies were used, the last dose of the antibody must be at least 4 weeks before
Day 1 dosing. This applies to participants enrolled in Main Study only.
10. Use of any investigational drugs, including any investigational drugs for IPF, within
4 weeks prior to Day 1 dosing.
11. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding
non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.
12. Diffusing capacity (DLCO) less than 30% of predicted value.
13. History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine
monoclonal antibodies.
14. Previous treatment with FG-3019.
15. Body weight greater than 130 kilograms.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Pamrevlumab
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Drug: Sub-Study: Pirfenidone
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Drug: Placebo
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Drug: Sub-Study: Nintedanib
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Primary Outcome(s)
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Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48
[Time Frame: Baseline (Screening and Day 1), Week 48]
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Secondary Outcome(s)
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Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48
[Time Frame: Baseline (Screening), Week 24 and Week 48]
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Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48
[Time Frame: Baseline (Day 1), Week 24 and Week 48]
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Number of Participants With a Respiratory-Related Hospitalization
[Time Frame: Week 55]
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Number of Participants With IPF Progression Events up to Week 48
[Time Frame: Baseline (Screening and Day 1) up to Week 48]
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Number of Participants With a Respiratory-Related Death
[Time Frame: Week 55]
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Number of Participants With No Decline in FVC (% Predicted) at Week 48
[Time Frame: Baseline (Day 1) to Week 48.]
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Secondary ID(s)
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FGCL-3019-067
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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