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Also known as ALXN1820
Tarperprumig · 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...
Tarperprumig is an investigational small molecule being developed for the treatment of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (AAV), a group of autoimmune diseases characterized by inflammation of blood vessels. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Tarperprumig is being developed by AstraZeneca PLC, a multinational biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 2 clinical trial to evaluate the safety and efficacy of Tarperprumig in adult participants with ANCA-associated vasculitis.
Tarperprumig is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The ongoing Phase 2 trial is recruiting participants and is designed to assess the safety and efficacy of the drug in patients with ANCA-associated vasculitis.
Tarperprumig is being studied in a Phase 2 clinical trial registered as NCT07160608, titled "Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis." The trial is currently recruiting and aims to enroll 75 participants across multiple countries, including the United States, Canada, and European nations.
No, Tarperprumig is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The ongoing study is evaluating its safety and efficacy in patients with ANCA-associated vasculitis, but it has not yet received marketing approval from the FDA or any other regulatory authority.
Tarperprumig is a small molecule therapeutic being developed for ANCA-associated vasculitis. However, its specific molecular target or mechanism of action has not been disclosed in available information. The drug is being evaluated in a randomized, double-blind, controlled Phase 2 trial to determine its safety and efficacy in treating this condition.