Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 811 · 2 trials · 2 indications
Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, and ECGs
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 2 subjects of each cohort (cohort 1 to 6) will receive placebo |
| AMG811 | OTHER | Six subjects in each cohort (cohort 1 to 6) will receive AMG 811 |
| AMG 811 | EXPERIMENTAL | AMG 811 administered as subcutaneous and intravenous doses |
| Name | Type | Description |
|---|---|---|
| AMG 811 | DRUG | Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks beginning with day 1 (D1) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period. |
| Placebo | DRUG | contains no active drug |
Inclusion Criteria: * Men and women, between the ages of 18 and 70 years of age; * Body mass index from 18 to 40 kg/m2 \[Body Weight (kg)/Height2 (m2)\] at screening; * Diagnosis of SLE at least 6 months before randomization, including a positive antinuclear antibodies (ANA) during screening; if sc...
AMG 811 is an investigational small molecule being developed for systemic lupus erythematosus and nephritis. It is intended for use in patients with systemic lupus erythematosus, with or without glomerulonephritis. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AMG 811 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with systemic lupus erythematosus.
AMG 811 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The completed Phase 1 trials have evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in patients with systemic lupus erythematosus.
AMG 811 has been studied in two completed Phase 1 clinical trials. The first, NCT00818948, enrolled 56 participants with systemic lupus erythematosus with and without glomerulonephritis. The second, NCT02291588, enrolled 26 participants with systemic lupus erythematosus. Both trials were randomized, double-blind, and placebo-controlled.
AMG 811 is a distinct investigational drug developed by Amgen. It is not known to be the same as any other marketed lupus treatment. Its mechanism of action and chemical structure are specific to this drug candidate, which is being evaluated for its potential role in managing systemic lupus erythematosus.