Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CSJ148 · 1 trial · 1 indication
Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is \>= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is \< 1000 copies/mL, but HCMV disease was reported
Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: CSJ148 | EXPERIMENTAL | Cohort 1: CSJ148 IV q 4weeks |
| Cohort 2: CSJ148 | EXPERIMENTAL | Cohort 2: CSJ148 IV q 4weeks |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Cohort 2: Placebo IV q 4weeks |
| Name | Type | Description |
|---|---|---|
| CSJ148 | BIOLOGICAL | CSJ148 IV q 4weeks |
| Placebo | DRUG | Placebo IV q 4weeks |
Inclusion Criteria: Patients eligible for inclusion in this study had to fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment was performed. 2. Male and female patients at least 18 years of age. 3. Patients weighed between 45 -120 kg to particip...
CSJ148 is an investigational monoclonal antibody being studied for the prevention or treatment of human cytomegalovirus (HCMV) infection. It is being developed for patients undergoing stem cell transplantation, a population at high risk for HCMV reactivation and disease.
CSJ148 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS.
CSJ148 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities.
CSJ148 has been evaluated in one completed Phase 2 trial, identified as NCT02268526. This study, titled 'Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients,' enrolled 86 participants across the United States, Belgium, Germany, Singapore, South Korea, and Taiwan.
Yes, CSJ148 is a monoclonal antibody, a type of biologic drug designed to target specific proteins involved in disease processes. It is being investigated for its potential to address HCMV infection in immunocompromised patients.