brodalumab

Generic Name: AMG 827
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20060279Rheumatoid Arthritis (RA) & Psoriasis (PsO)1A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827 in Healthy Subjects and Subjects with Moderate to Severe Psoriasis
20070264Rheumatoid arthritis (RA)1b/2aA Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
20090061Rheumatoid Arthritis (RA)2A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate
20090062Moderate to severe plaque psoriasis2A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Psoriasis
20090072Crohn's disease2A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn’s Disease
20090203AMG 827 for the treatment of Asthma2A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
20090402Rheumatoid arthritis2A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis
20090403Moderate to severe plaque psoriasis2A Long-term Assessment of the Safety and Efficacy of Brodalumab Subcutaneous Treatment in Subjects With Psoriasis
20090480Inflammatory Disease (Psoriasis)1An Open-label, Randomized, 2-period Crossover Study to Compare the Pharmacokinetic Bioequivalence of a Single 210 mg Dose of Brodalumab Administered to Healthy Subjects by Subcutaneous Injection Using a Prefilled Syringe and an Autoinjector
20100008Crohn's disease2A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease
20101227Psoriatic Arthritis2Randomized, Double-blind, Placebo-controlled, Multiple-dose Study with an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects with Psoriatic Arthritis
20110106AMG 827 is being developed to treat psoriasis, asthma and Crohn’s disease. This study is in healthy volunteers.1A Randomized Open Label Study in Healthy Subjects Evaluating the Tolerability, Safety, Acceptability and performance of Two Auto-Injector Devices Used to Subcutaneously Administer AMG 827
20110184Inflammatory Disease (psoriasis)1An Open-label Study to Evaluate the Effect of Brodalumab on the Pharmacokinetics of Midazolam and Assess Single-dose Brodalumab Pharmacokinetics in Subjects with Moderate to Severe Plaque Psoriasis
20120102Moderate to severe plaque psoriasis3A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
20120103Moderate to severe plaque psoriasis3A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
20120104Moderate to severe plaque psoriasis3A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
20120337Inflammatory Disease (psoriasis, psoriatic arthritis, and asthma)1A Study to Evaluate the Intra-subject Variability of Brodalumab Pharmacokinetic Parameters in Healthy Subjects
20130307Inflammatory Disease (Psoriasis)1

A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects