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Also known as ALXN1720 SC, Gefurulimab PFS-SD, Gefurulimab AI
ALXN1720 · 3 trials · 3 indications
The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
| Arm | Type | Description |
|---|---|---|
| ALXN1720 | EXPERIMENTAL | Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720. |
| Gefurulimab PFS-SD | EXPERIMENTAL | Participants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm. |
| Gefurulimab AI | EXPERIMENTAL | Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm. |
| Name | Type | Description |
|---|---|---|
| ALXN1720 | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with ALXN1720. |
| Placebo | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with placebo. |
| Gefurulimab PFS-SD | DRUG | Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1. |
| Gefurulimab AI | DRUG | Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1. |
Inclusion Criteria: * Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV * Positive serological test for autoantibodies against AChR Exclusion Criteria: * History of thymectomy, or any other ...
ALXN1720 is an investigational monoclonal antibody being developed for generalized myasthenia gravis and for proteinuria. The generalized myasthenia gravis program is in Phase 3, while the proteinuria program has completed a Phase 1 study. It is not approved for any indication.
ALXN1720 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the drug in generalized myasthenia gravis and proteinuria.
ALXN1720 is in Phase 3 development for generalized myasthenia gravis. A Phase 1 study in proteinuria has been completed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
ALXN1720 has been studied in two clinical trials. NCT05556096 is a Phase 3 trial in adults with generalized myasthenia gravis that is active but not recruiting, with 260 participants enrolled across 23 countries. NCT05314231 was a completed Phase 1 pharmacokinetic study in 13 participants with proteinuria in South Korea.
Yes, ALXN1720 SC is another name for ALXN1720. The SC designation refers to the subcutaneous formulation of the monoclonal antibody. Both names refer to the same investigational drug being developed by AstraZeneca for generalized myasthenia gravis and proteinuria.
ALXN1720 is administered subcutaneously, as reflected in the alternative name ALXN1720 SC. The Phase 3 trial in generalized myasthenia gravis and the completed Phase 1 proteinuria study both evaluated subcutaneous dosing of the monoclonal antibody.