Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 531 · 7 trials · 11 indications
Number of weeks with weekly platelet response. A weekly platelet response is defined as a platelet count of ≥ 50 x 10\^9/L on a weekly scheduled dose day from week 2 to week 13.
Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.
Occurrence of one or more adverse events in the participant during the 12-week treatment period
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
| Arm | Type | Description |
|---|---|---|
| AMG 531 | PLACEBO_COMPARATOR | Double blinded placebo-controlled study |
| Placebo | PLACEBO_COMPARATOR | - |
| 750 mcg AMG 531 | ACTIVE_COMPARATOR | 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
| Placebo Part A | PLACEBO_COMPARATOR | Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| 500 mcg AMG 531 | ACTIVE_COMPARATOR | 500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) |
| 750 mcg AMG531 Part B | ACTIVE_COMPARATOR | 750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) |
| Dose level 1 500 AMG 531 (Part A - azacitidine) | ACTIVE_COMPARATOR | 500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles |
| Dose level 1 750 AMG 531 (Part B - decitabine) | ACTIVE_COMPARATOR | 750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles |
| Dose level 2 750 AMG 531 (Part A - azacitidine) | ACTIVE_COMPARATOR | 750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles |
| Placebo (Part A - azacitidine) | PLACEBO_COMPARATOR | Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles |
| Placebo (Part B - decitabine) | PLACEBO_COMPARATOR | Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles |
| II. | PLACEBO_COMPARATOR | 5 thrombocytopenic (as defined per protocol) subjects |
| I. | EXPERIMENTAL | 15 thrombocytopenic (as defined per protocol) subjects |
| Single Arm: AMG 531 Dose-Escalating Cohort Study | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subcutaneously administered, once a week, for 12 weeks |
| AMG 531 | DRUG | Subcutaneously administered, once a week, for 12 weeks |
| AMG 531 (Romiplostim) | BIOLOGICAL | AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization. |
| Azacitidine | DRUG | hypomethylating agent |
| Decitabine | DRUG | hypomethylating agent |
Inclusion Criteria: * Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of Health, Labour and Welfare \[MHLW\] (revised in 1990) at least 6 months before the first screening visit * The ...
AMG 531 is an investigational monoclonal antibody being studied for thrombocytopenia, including immune (idiopathic) thrombocytopenic purpura (ITP), myelodysplastic syndromes (MDS), and chemotherapy-induced thrombocytopenia. It is being developed by Amgen Inc. (NASDAQ: AMGN) and is currently in clinical trials.
AMG 531 targets the thrombopoietin receptor to stimulate platelet production. It is a monoclonal antibody designed to treat thrombocytopenia, a condition characterized by low platelet counts, in patients with ITP, MDS, and other related disorders.
AMG 531 is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the safety and efficacy of AMG 531 in patients with thrombocytopenia associated with ITP and MDS.
AMG 531 is in Phase 1 clinical development, although completed trials include Phase 2 and Phase 3 studies. It is an investigational drug and not yet approved by regulatory authorities. Amgen has completed multiple trials in ITP and MDS patients.
AMG 531 has been studied in several completed trials, including NCT00102323 and NCT00102336 for ITP, NCT00321711 for MDS with hypomethylating agents, and NCT00418665 for MDS with Revlimid. These trials enrolled a total of 233 patients across all studies.
Yes, AMG 531 is also known as romiplostim. In clinical trials, it has been referred to by both names. Romiplostim is being investigated for its ability to increase platelet counts in patients with thrombocytopenia due to ITP or MDS.