9 completed, 9 terminated, 1 withdrawn. 8 Phase 2, 6 Phase 1, 6 Phase 3, 1 Not applicable.
By phase and status
Follow pamrevlumab: new trials by email Literature Review of pamrevlumab trials Research Report on pamrevlumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD Pamrevlumab, Placebo, Corticosteroids - Duchenne Muscular Dystrophy Phase 3 Terminated Kyntra Bio 73 2021-03-03 2024-08-26
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Pamrevlumab, Placebo - Idiopathic Pulmonary Fibrosis Phase 3 Terminated Kyntra Bio 372 2020-09-30 2024-08-12
Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD) Pamrevlumab, Placebo, Corticosteroids - Duchenne Muscular Dystrophy Phase 3 Terminated Kyntra Bio 98 2020-08-10 2024-03-12
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease Pamrevlumab, Placebo - COVID-19 Phase 2 Terminated Kyntra Bio 22 2020-06-20 2022-07-18
An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19 Pamrevlumab - COVID-19 Respiratory Infection, COVID-19 Pneumonia Phase 2 / Phase 3 Completed Fondazione Policlinico Universitario Agostino Gemelli IRCCS 42 2020-05-12 2022-03-02
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Pamrevlumab, Placebo - Idiopathic Pulmonary Fibrosis Phase 3 Terminated Kyntra Bio 393 2019-06-18 2024-09-19
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX, Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX - Pancreatic Cancer Non-resectable Phase 3 Completed Kyntra Bio 284 2019-05-10 2024-11-05
Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer FG-3019 - Pancreatic Cancer Not applicable Withdrawn Jonsson Comprehensive Cancer Center 2016-08-01 2016-10-07
Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD) Pamrevlumab - Duchenne Muscular Dystrophy Phase 2 Terminated Kyntra Bio 21 2016-01-04 2024-08-27
A Study of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 in Participants With Locally Advanced, Unresectable Pancreatic Cancer FG-3019, Gemcitabine, Nab-paclitaxel - Pancreatic Cancer (Unresectable) Phase 1 / Phase 2 Completed Kyntra Bio 37 2014-07-31 2023-03-02
Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF) Pamrevlumab, Placebo, Sub-Study: Pirfenidone - Idiopathic Pulmonary Fibrosis Phase 2 Completed Kyntra Bio 160 2013-07-30 2020-09-04
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis FG-3019 - Idiopathic Pulmonary Fibrosis Phase 2 Completed Kyntra Bio 90 2011-03-01 2019-10-09
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection FG-3019, Placebo, Entecavir - Liver Fibrosis Due to Chronic Hepatitis B Infection Phase 2 Terminated Kyntra Bio 114 2010-08-01 2016-08-16
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy FG-3019, Placebo - Type 2 Diabetes Mellitus, Diabetic Nephropathy Phase 2 Terminated Kyntra Bio 46 2009-02-01 2019-02-22
A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer FG-3019 - Locally Advanced or Metastatic Pancreatic Cancer Phase 1 Completed Kyntra Bio 50 2008-12-01 2014-08-06
Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS) FG-3019 - Focal Segmental Glomerulosclerosis Phase 1 Terminated Kyntra Bio 2 2008-04-01 2019-07-31
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy FG-3019 - Diabetes Mellitus, Diabetic Nephropathy Phase 1 Completed Kyntra Bio 38 2008-03-01 2019-08-02
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus FG-3019 - Diabetes Mellitus Phase 1 Completed Kyntra Bio 20 2005-01-01 2007-12-12
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis FG-3019 - Idiopathic Pulmonary Fibrosis Phase 1 Completed Kyntra Bio 21 2003-12-08 2023-07-12
Conditions studied Idiopathic Pulmonary Fibrosis (5) · Pulmonary Fibrosis (4) · Diabetes Mellitus, Type 2 (3) · Idiopathic Interstitial Pneumonias (3) · Lung Diseases, Interstitial (3) · Muscular Dystrophy, Duchenne (3) · Pancreatic Neoplasms (3) · COVID-19 (2) · Diabetes Mellitus (2) · Diabetic Nephropathies (2) · Genetic Diseases, Inborn (1) · Genetic Diseases, X-Linked (1) · Glomerulosclerosis, Focal Segmental (1) · Muscular Diseases (1) · Muscular Disorders, Atrophic (1)
Sponsors Kyntra Bio (17) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (1) · Jonsson Comprehensive Cancer Center (1)
Countries United States (16) · China (5) · Italy (5) · Australia (4) · Canada (4) · France (4) · Spain (4) · United Kingdom (4) · Austria (3) · Belgium (3) · Netherlands (3) · South Korea (3) · Argentina (2) · Czechia (2) · Germany (2)
Top investigators Albert C Koong, MD, PhD (1) · Anish Ambaram, M.D. (1) · Benedict Brockway, M.D. (1) · Bhanu Singh, M.D. (1) · Catherina Chang, M.D. (1) · Charles Lopez, MD (1) · Danielle Antin-Ozerkis, M.D. (1) · Danielle D. Hosmer (1) · David Lederer, M.D. (1) · Elizabeth Veitch, M.D. (1) · Elvis Irusen, M.D. (1) · Evans R Fernandez-Perez, M.D (1) · Frank Valone, MD (1) · Heidi Siebert, M.D. (1) · Huw Davies, M.D. (1)
Results publications PMID 35204752 , PMID 40355288 , PMID 26965296 , PMID 31575509 , PMID 37605035 , PMID 38762797 , PMID 41805697
NIH funding 2023 (1)