AMG 811 / Amgen - LARVOL DELTA

A phase I single-dose crossover study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of AMG 811 (anti-IFN-gamma) in subjects with discoid lupus erythematosus (ACR-ARHP 2013) - Presentation time: Monday, October 28, 2013; 8:30 am - 4:00 pm; Abstract #1608; P1, N=16; NCT01164917; Sponsor: Amgen; "IFN-g modulated genes were elevated in both blood and lesional skin, indicating the presence of an interferon signature. In blood AMG 811 led to a dose dependent modulation of the expression of genes previously shown to be modulated by AMG 811 in subjects with SLE. Histopathology and RNA transcript analysis revealed substantial intra- and inter-subject heterogeneity between skin biopsies from DLE subjects at baseline and following AMG 811 treatment."

P1 data • Immunology • Lupus

Safety, pharmacokinetics and pharmacodynamics of AMG 811 (antiIFN-gamma): Results of a phase I single dose study in subjects with systemic lupus erythematosus (Lupus 2013) - Abstract# O23; Presentation time: 20/04/13; 10:40 - 11:40; P1, N=20; Sponsor: Amgen; NCT01164917; "AMG 811 demonstrated acceptable safety and favorable PK profiles following single dose administration to SLE subjects. AMG 811 administration impacted IFN-associated gene expression. The identity of impacted genes and the magnitude of modulation following AMG 811 treatment in SLE subjects suggest that the lupus ‘interferon signature’ is not solely derived from Type I IFN."

P1 data • Immunology • Lupus

AMG-811 shows mixed results in patients with SLE in phase 1 study (Healio) - P1, N=28; NCT00818948; Sponsor: Amgen; "Amgen’s experimental AMG-811 may lower serum CXCL-10 and interferon-gamma-modulated mRNA levels in patients with systemic lupus erythematosus and lupus nephritis, according to recently presented data...Improvements in proteinuria were seen in some patients; however, the researchers noted that no consistent differences were observed at week 12 between the cohorts in renal outcomes or serum biomarkers related to SLE."

Conference • P1 data • Lupus

Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis (clinicaltrials.gov) - P1; N=56; Active, not recruiting; Sponsor: Amgen; Trial completion date: Jul 2014 ->Aug 2014

Trial completion date • Biosimilar • Chronic Kidney Disease • Immunology • Lupus • Renal Disease • Reperfusion Injury

Type II but Not Type I Interferon Signifies Clinical Response to Ustekinumab in Patients with Systemic Lupus Erythematosus (LUPUS 2019) - P2a; "Although targeting IFN-I (anifrolumab) has demonstrated inconsistent efficacy and a preliminary study with anti-IFN-gamma mAb (AMG811) failed to establish benefit,(2,3) we sought to determine if UST affects either pathway and if those effects correlated with a positive SRI-4 response at wk24. (5) Welcher AA. Arthritis&Rheumatol.2015;67:2713."

Clinical