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Also known as ALXN1820 SC, Tarperprumig
ALXN1820 · 2 trials · 2 indications
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.
| Arm | Type | Description |
|---|---|---|
| Tarperprumig Group 1 | EXPERIMENTAL | Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. |
| Tarperprumig Group 2 | EXPERIMENTAL | Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. |
| Placebo Group 3 | EXPERIMENTAL | Participants will be administered placebo. |
| ALXN1820 | EXPERIMENTAL | Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Placebo SC or Placebo IV according to their assigned cohort. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive placebo. |
| Tarperprumig | DRUG | Participants will receive tarperprumig. |
| ALXN1820 SC | DRUG | ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks. |
| ALXN1820 IV | DRUG | ALXN1820 IV (450 mg) will be administered as an IV infusion. |
| Placebo SC | DRUG | Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump. |
| Placebo IV | DRUG | Placebo IV will be administered as an IV infusion. |
Inclusion Criteria: * Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered. * Positive test for antibodies to either PR3-ANCA or MP...
ALXN1820 is an investigational small molecule drug developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed.
ALXN1820 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sole developer listed for this asset.
ALXN1820 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
ALXN1820 has been evaluated in a single Phase 1 trial, NCT04631562, titled "Study of ALXN1820 in Healthy Adult Participants." The trial enrolled 66 healthy volunteers, was randomized, double-blind, and placebo-controlled, and was conducted in Australia and the United Kingdom.
Yes, ALXN1820 SC is an alternative name for ALXN1820. Both names refer to the same investigational small molecule developed by AstraZeneca PLC.