Drugs / Simtuzumab
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01362231 | Dec 2010 → Dec 2012 | idiopathic pulmonary fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01323933 | Jun 2010 → Mar 2012 | neoplasm | Gilead Sciences | Completed | No outcome recorded |
| Phase 211 trials · 6 missed | ||||||
| Phase 2 | NCT02466516 | Jun 2015 → Oct 2016 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01672853 | Mar 2013 → Aug 2016 | primary sclerosing cholangitis | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT01769196 | Jan 2013 → Feb 2016 | idiopathic pulmonary fibrosis | Gilead Sciences | Terminated | Missed primary |
| Phase 2 | NCT01672866 | Dec 2012 → Aug 2016 | fibrotic liver disease | Gilead Sciences | Terminated | Missed primary |
| Phase 2 | NCT01672879 | Oct 2012 → Sep 2016 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Terminated | Missed primary |
| Phase 2 | NCT01759511 | Oct 2012 → Feb 2016 | idiopathic pulmonary fibrosis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT01707472 | Oct 2012 → Oct 2014 | HIV infectious disease, fibrotic liver disease, hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01479465 | Dec 2011 → Oct 2014 | colorectal cancer | Gilead Sciences | Terminated | Missed primary |
| Phase 2 | NCT01472198 | Nov 2011 → Oct 2013 | malignant pancreatic neoplasm | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT01452308 | Nov 2011 → Jan 2013 | fibrotic liver disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01369498 | Jun 2011 → Jun 2014 | myelofibrosis | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2017-04-20 | Gilead Sciences | Results Gilead to Present Clinical and Preclinical Data on Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress™ 2017 gilead.com ↗
These analyses indicate that the primary determinant of progression to cirrhosis in patients with bridging fibrosis or to events of hepatic decompensation in patients with cirrhosis is the fibrosis stage at baseline, and its change over time. |
| 2016-11-14 | Gilead Sciences | Results Phase 2 Data for Selonsertib in Nonalcoholic Steatohepatitis (NASH) Presented at The Liver Meeting® 2016 gilead.com ↗
As no differences were observed between combination and monotherapy, results are presented for selonsertib (18 mg and 6 mg) with/without SIM and for SIM alone. |
| 2016-10-20 | Gilead Sciences | Results Gilead Announces Top-Line Phase 2 Results for GS-4997 (Selonsertib) in Nonalcoholic Steatohepatitis (NASH), Pulmonary Arterial Hypertension (PAH) and Diabetic Kidney Disease (DKD) gilead.com ↗
Top-line efficacy data for fibrosis-related endpoints from 67 evaluable patients are summarized in the table below. |
| 2016-01-05 | Gilead Sciences | Results Gilead Terminates Phase 2 Study of Simtuzumab in Patients With Idiopathic Pulmonary Fibrosis gilead.com ↗
This decision follows an analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. |
| 2014-09-17 | Gilead Sciences | Results Gilead Announces Data From Phase 2 Study of Simtuzumab for Previously Untreated Pancreatic Cancer gilead.com ↗
In the study, the addition of simtuzumab (200 mg or 700 mg) to gemcitabine did not significantly increase progression-free survival (PFS) compared to placebo plus gemcitabine. |
All press releases naming this drug 5 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Simtuzumab | “We evaluated the safety and efficacy of simtuzumab, a monoclonal antibody against lysyl oxidase-like 2, in two phase 2b trials of patients with advanced fibrosis caused by...” PMID 29990488 ↗ Jul 201810“Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)” NCT01672866 ↗ “Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly” NCT02466516 ↗ |
| Known as | AB0024 | “A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis” NCT01362231 ↗ |
| Known as | GS-6624 | “This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.” NCT01452308 ↗ |
| Known as | SIM | “Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)” NCT01672866 ↗1“Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly” NCT02466516 ↗ |
| Action | Inhibit | “simtuzumab inhibits the extracellular matrix-remodeling enzyme lysyl oxidase-like 2” PMID 28246206 ↗ Feb 2017 |
| Modality | Monoclonal antibody | “The humanized IgG4 monoclonal antibody simtuzumab inhibits the extracellular matrix-remodeling enzyme lysyl oxidase-like 2 maintaining pathological stroma in tumors.” PMID 28246206 ↗ Feb 2017 |
| Route | Intravenous | “after multiple IV administrations” NCT01323933 ↗ |
| Target | LOXL2 | “a monoclonal antibody directed against LOXL2” PMID 30153359 ↗ Jan 2019 |