Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 811 · 3 trials · 3 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 | - |
| AMG 811 | EXPERIMENTAL | - |
| AMG811 | OTHER | Six subjects in each cohort (cohort 1 to 6) will receive AMG 811 |
| Name | Type | Description |
|---|---|---|
| AMG 811 or Placebo | DRUG | Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis. |
| 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: * 18 - 55 years old inclusive at Screening * Active but clinically stable, plaque psoriasis * Psoriasis involving ≥ 10% of the body surface area * A minimum PASI score of ≥ 10 obtained during the screening period * Additional inclusion criteria apply Exclusion Criteria: * Acti...
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AMG 811 is an investigational small molecule developed by Amgen Inc. for immunology indications. It has been studied in clinical trials involving patients with systemic lupus erythematosus, lupus nephritis, and psoriasis. It remains in Phase 1 clinical development and is not an approved therapy.
AMG 811 has been evaluated in clinical trials for systemic lupus erythematosus, lupus nephritis, and psoriasis. These are the conditions studied in its Phase 1 program. No approved use has been established, and the drug remains investigational for all of these immunology indications.
AMG 811 is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the Phase 1 clinical trials evaluating the drug in systemic lupus erythematosus, lupus nephritis, and psoriasis.
AMG 811 is in Phase 1 clinical development. Its trials in systemic lupus erythematosus, lupus nephritis, and psoriasis have all been completed, and no later-phase studies are listed. The drug is investigational and has not been approved for any indication.
AMG 811 has been studied in three completed Phase 1 trials: NCT02291588 in systemic lupus erythematosus, NCT01510951 in psoriasis, and NCT00818948 in systemic lupus erythematosus with and without glomerulonephritis. All were randomized, double-blind, and placebo-controlled studies in adults.
The AMG 811 Phase 1 program enrolled patients across three completed trials. NCT00818948 enrolled 56 participants, NCT02291588 enrolled 26, and NCT01510951 enrolled 9. All studies required participants to be at least 18 years old and enrolled both sexes.