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AMG 557 · 3 trials · 2 indications
Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory safety tests, and ECGs
| Arm | Type | Description |
|---|---|---|
| AMG 557 | ACTIVE_COMPARATOR | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
| AMG 557 Matching Placebo | PLACEBO_COMPARATOR | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 557 | DRUG | AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
| Matching Placebo | DRUG | Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
| Placebo | DRUG | contains no active drug |
Inclusion Criteria: * Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria * Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)...
AMG 557 is an investigational small molecule being developed for lupus arthritis and systemic lupus erythematosus. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in adults aged 18 years and older with these autoimmune conditions.
AMG 557 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 efficacy of this investigational drug in patients with lupus-related conditions.
AMG 557 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. All three completed trials for AMG 557 were Phase 1 studies, with a total enrollment of 115 participants.
AMG 557 has been studied in three completed Phase 1 clinical trials: NCT00774943 in adults with systemic lupus erythematosus, NCT01683695 in subjects with lupus arthritis, and NCT02391259 evaluating safety, pharmacokinetics, and pharmacodynamics in systemic lupus erythematosus. All trials were placebo-controlled and double-blind.
AMG 557 is a distinct investigational drug developed by Amgen for lupus arthritis and systemic lupus erythematosus. It is a small molecule in Phase 1 development, and no alternative names have been reported for this compound. Its mechanism of action has not been publicly disclosed in available trial information.