Selected current clinical trials in novel therapeutics
| NCT number . | Study title . | Conditions . | Interventions . | Results . |
|---|---|---|---|---|
| NCT05885555 | A Study of Ianalumab (VAY736) in Patients with Primary Immune Thrombocytopenia (ITP) Previously Treated with at Least Two Lines of Therapies | Primary immune thrombocytopenia (ITP) | Ianalumab | Pending |
| NCT05653349 | Study of Ianalumab versus Placebo in Addition to First-Line Corticosteroids in Primary Immune Thrombocytopenia (ITP) | Primary ITP | Ianalumab vs placebo or corticosteroids | Pending |
| NCT05338190 | Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia | Primary ITP | Rituximab with subcutaneous belimumab | Rituximab with subcutaneous placebo | Pending |
| NCT04562766 | Study to Evaluate Rilzabrutinib in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP) | ITP | Rilzabrutinib vs placebo | Pending |
| NCT05599880 | The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients with Relapsed/Refractory Immune Thrombocytopenia | Relapsed/ refractory ITP | Bortezomib | Pending |
| NCT06281327 | Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia | Persistent or chronic pediatric ITP | Avatrombopab vs placebo | Pending |
| NCT03154385 | Efficacy and Safety Assessment of a Treatment Combining Rituximab and Belimumab in Adults with Persistent Immune Thrombocytopenia (RITUX PLUS) | Persistent and chronic ITP | Belimumab with rituximab | Primary: 80% CR + R at 52 weeks with 66.7% with CR; secondary: 86.7% initial overall response (13/15). Safety: primarily related to rituximab infusions; 8 AE possibly related to tx but no SAE. |
| NCT03275454 | A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple-Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) | Chronic ITP | Sutimlimab | Primary: safety: 1 serious not related to drug; 1 serious related to drug (migraine). Efficacy: 42% R and CR in 33%; rapid response (~24 hrs) |
| NCT03102593 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with ITP | Chronic ITP | Efgartigimod | Primary: safety: 1 SAE worsening thrombocytopenia leading to discontinuation; extension: 2 SAE: pneumonia and endometrial polyposis. Efficacy: CR 38.5% 5 mg/kg arm; 38.5% 10 mg/kg arm; 16.7% placebo |
| NCT03395210 | A Study of Rilzabrutinib in Adult Patients with Immune Thrombocytopenia (ITP) | Chronic, refractory ITP | Rilzabruitinib vs place | Primary: 26.7% (CR or R) and durable; entered LTE at 400 mg BID and of those 92% continue to have plt ≥50 × 109/L. Safety: 4 patients with respiratory infections (COVID-19, bronchitis, COVID-19 pneumonia); 3 serious AE: COVID-19 pneumonia; grade 4 thrombocytopenia; grade 3 pneumonia/pulmonary embolism |
| NCT number . | Study title . | Conditions . | Interventions . | Results . |
|---|---|---|---|---|
| NCT05885555 | A Study of Ianalumab (VAY736) in Patients with Primary Immune Thrombocytopenia (ITP) Previously Treated with at Least Two Lines of Therapies | Primary immune thrombocytopenia (ITP) | Ianalumab | Pending |
| NCT05653349 | Study of Ianalumab versus Placebo in Addition to First-Line Corticosteroids in Primary Immune Thrombocytopenia (ITP) | Primary ITP | Ianalumab vs placebo or corticosteroids | Pending |
| NCT05338190 | Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia | Primary ITP | Rituximab with subcutaneous belimumab | Rituximab with subcutaneous placebo | Pending |
| NCT04562766 | Study to Evaluate Rilzabrutinib in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP) | ITP | Rilzabrutinib vs placebo | Pending |
| NCT05599880 | The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients with Relapsed/Refractory Immune Thrombocytopenia | Relapsed/ refractory ITP | Bortezomib | Pending |
| NCT06281327 | Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia | Persistent or chronic pediatric ITP | Avatrombopab vs placebo | Pending |
| NCT03154385 | Efficacy and Safety Assessment of a Treatment Combining Rituximab and Belimumab in Adults with Persistent Immune Thrombocytopenia (RITUX PLUS) | Persistent and chronic ITP | Belimumab with rituximab | Primary: 80% CR + R at 52 weeks with 66.7% with CR; secondary: 86.7% initial overall response (13/15). Safety: primarily related to rituximab infusions; 8 AE possibly related to tx but no SAE. |
| NCT03275454 | A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple-Dose BIVV009 in Participants With Chronic Immune Thrombocytopenia (ITP) | Chronic ITP | Sutimlimab | Primary: safety: 1 serious not related to drug; 1 serious related to drug (migraine). Efficacy: 42% R and CR in 33%; rapid response (~24 hrs) |
| NCT03102593 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with ITP | Chronic ITP | Efgartigimod | Primary: safety: 1 SAE worsening thrombocytopenia leading to discontinuation; extension: 2 SAE: pneumonia and endometrial polyposis. Efficacy: CR 38.5% 5 mg/kg arm; 38.5% 10 mg/kg arm; 16.7% placebo |
| NCT03395210 | A Study of Rilzabrutinib in Adult Patients with Immune Thrombocytopenia (ITP) | Chronic, refractory ITP | Rilzabruitinib vs place | Primary: 26.7% (CR or R) and durable; entered LTE at 400 mg BID and of those 92% continue to have plt ≥50 × 109/L. Safety: 4 patients with respiratory infections (COVID-19, bronchitis, COVID-19 pneumonia); 3 serious AE: COVID-19 pneumonia; grade 4 thrombocytopenia; grade 3 pneumonia/pulmonary embolism |
AE, adverse event; CR, complete response; LTE, long-term efficacy; plt, platelet; R, response; SAE, severe adverse event; tx, treatment.