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Also known as VAY736 1ml PFS
VAY736 PFS · 1 trial · 3 indications
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL AI and 2 x 1 mL PFS
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
To demonstrate the pharmacokinetics (PK) comparability of ianalumab 300 mg s.c. at steady state between the 1 x 2 mL PFS and 2 x 1 mL PFS.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Sequence 1 + Thigh | EXPERIMENTAL | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 1 + Abdomen | EXPERIMENTAL | Patients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 2 + Thigh | EXPERIMENTAL | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh (1 X 2 mL) AI in TP2 in Thigh (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 1: Sequence 2 + Abdomen | EXPERIMENTAL | Patients randomized to receive injection 1. X 2 mL) AI in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (1 x 2 mL) AI in ETP in Thigh/ Abdomen |
| Cohort 2: Sequence 1 + Thigh | EXPERIMENTAL | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Thigh 1. X 2 mL) PFS in TP2 in Thigh 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 1 + Abdomen | EXPERIMENTAL | Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Abdomen 2. x 1 mL) PFS in TP2 in Abdomen (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 1 + Upper Arm | EXPERIMENTAL | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Upper Arm 1. X 2 mL) PFS in TP2 in Upper Arm 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Thigh | EXPERIMENTAL | Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Thigh 2. x 1 mL) PFS in TP2 in Thigh (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Abdomen | EXPERIMENTAL | Patients randomized to receive injection (2 x 1 mL) PFS in TP1 in Abdomen 1. X 2 mL) PFS in TP2 in Abdomen 2. x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Cohort 2: Sequence 2 + Upper Arm | EXPERIMENTAL | Patients randomized to receive injection 1. X 2 mL) PFS in TP1 in Upper Arm 2. x 1 mL) PFS in TP2 in Upper Arm (2 x 1 mL) PFS in ETP in Thigh/ Abdomen/ Upper Arm |
| Name | Type | Description |
|---|---|---|
| VAY736 1ml PFS | BIOLOGICAL | Solution for injection. |
| VAY736 2 ml PFS | BIOLOGICAL | Solution for injection |
| VAY736 2ml AI | BIOLOGICAL | Solution for injection. |
Key Inclusion criteria: * Signed informed consent must be obtained before any assessment is performed. * Male and female patients aged 18 years to 70 years (inclusive). * Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI...
VAY736 PFS is an investigational monoclonal antibody being developed for Sjögrens Disease, an autoimmune condition. It is also being studied in related autoimmune diseases including systemic lupus erythematosus and rheumatoid arthritis. The drug is administered subcutaneously and is currently in Phase 2 clinical development.
VAY736 PFS is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its effects in autoimmune diseases such as Sjögrens Disease, systemic lupus erythematosus, and rheumatoid arthritis.
VAY736 PFS is developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for autoimmune indications.
VAY736 PFS is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is designed to evaluate the pharmacokinetics of the drug in adult participants with autoimmune diseases.
VAY736 PFS is being studied in clinical trial NCT06293365, a Phase 2, two-period crossover study. The trial aims to demonstrate comparability of pharmacokinetics between different delivery devices in adult participants with autoimmune diseases. It is active but not recruiting, with an enrollment of 155 participants.
Yes, VAY736 PFS is also known as VAY736 1ml PFS. The name refers to the pre-filled syringe formulation of the drug, which is being evaluated for subcutaneous administration in autoimmune disease patients.