Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
rVA576 · 2 trials · 2 indications
Haemoglobin stabilisation rate defined as haemoglobin greater than the set point for each patient during the pre-study randomisation period and the avoidance of PRBC transfusions during the treatment period.
Proportion of participants reporting grade 3, 4 and 5 adverse events, which are related/possibly related to rVA576 during the treatment period. Treatment emergent adverse events (TEAEs) consist of: * Change from baseline in physical examination * ECG * Clinical laboratory tests * Vital signs The Common Terminology Criteria for Adverse Events (CTCAE v4.03) will be used to grade adverse events.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - 9 months of treatment (rVA576 plus SOC) | EXPERIMENTAL | 6 months (SOC plus rVA576), Followed by a further 3 months of (SOC plus rVA576). |
| Arm 2 - 6 months on SOC | EXPERIMENTAL | 6 months on SOC only. Followed by 3 months (SOC plus rVA576). |
| Open-label single arm study | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| rVA576 | DRUG | 6 months of treatment, rVA576 plus SOC. Followed by a further 3 months of rVA576 plus SOC. In total, 9 months on rVA576 plus SOC. |
| Standard of care (SOC) | OTHER | 6 months on SOC followed by 3 months of treatment with rVA576 plus SOC. In total, 3 months on rVA576 plus SOC. |
Inclusion Criteria: 1. Willing to give informed consent to treatment with rVA576 2. Diagnosed with paroxysmal nocturnal haemoglobinuria (PNH) 3. Have not received any complement inhibitor within the 4 months prior to screening 4. ≥ 18 years of age at the time of screening 5. Weight ≥50kg 6. Complet...
rVA576 is an investigational small molecule being developed for Bullous Pemphigoid (BP) and Paroxysmal Nocturnal Hemoglobinuria (PNH). It is being studied in adult patients with these conditions, with clinical trials conducted in countries including Germany, Netherlands, Kazakhstan, Lithuania, and Sri Lanka.
rVA576 is being developed by Akari Therapeutics Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol AKTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Bullous Pemphigoid and Paroxysmal Nocturnal Hemoglobinuria.
rVA576 is in Phase 2 clinical development for Bullous Pemphigoid and has completed a Phase 3 trial for Paroxysmal Nocturnal Hemoglobinuria. Both trials are completed, and the drug remains investigational, meaning it is not yet approved by regulatory authorities.
rVA576 has been studied in two completed clinical trials. NCT03588026 was a Phase 3 trial in Paroxysmal Nocturnal Hemoglobinuria with 9 participants in Kazakhstan, Lithuania, and Sri Lanka. NCT04035733 was a Phase 2 trial in Bullous Pemphigoid with 9 participants in Germany and Netherlands.
No alternative names for rVA576 have been disclosed. The drug is identified by its code name rVA576 in clinical trial registrations and by the developer Akari Therapeutics Plc. It is a distinct investigational small molecule being studied for Bullous Pemphigoid and Paroxysmal Nocturnal Hemoglobinuria.