Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 drug being studied for the treatment of systemic lupus erythematosus and lupus arthritis. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Clinical trials have evaluated its safety and effects in adult patients 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 drug is currently in Phase 1 clinical trials for systemic lupus erythematosus and lupus arthritis, and remains an investigational compound.
AMG 557 is in Phase 1 clinical development. It is an investigational drug, meaning it has not received regulatory approval. Three Phase 1 trials have been completed, evaluating the drug in adults with systemic lupus erythematosus and lupus arthritis.
AMG 557 has been studied in three completed Phase 1 clinical trials. NCT00774943 enrolled 58 adults with systemic lupus erythematosus in the United States and Canada. NCT01683695 enrolled 20 subjects with lupus arthritis across multiple countries. NCT02391259 enrolled 57 subjects with systemic lupus erythematosus in the United States and United Kingdom.
Yes, AMG 557 is classified as a small molecule drug. It is being developed for use in immunology, specifically targeting systemic lupus erythematosus and lupus arthritis. The drug is administered to adult patients and has been evaluated in placebo-controlled, double-blind Phase 1 studies.