Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRN1008 · 1 trial · 1 indication
Treatment-emergent adverse events (TEAEs) including clinically significant changes in physical examination, laboratory tests, and vital signs. An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to study completion.
CDA was defined as the time at which new lesions cease to form and established lesions begin to heal.
| Arm | Type | Description |
|---|---|---|
| PRN1008 | EXPERIMENTAL | Part A: Open-label PRN1008, 12 weeks; 12 weeks follow-up; Part B: Open-label PRN1008, 24 weeks; 4 weeks follow-up |
| Name | Type | Description |
|---|---|---|
| PRN1008 | DRUG | Part A dosing was initiated administering 400 mg BID. Intrapatient dose adjustments (reductions and increases) were permitted based upon tolerability and clinical response with the maximum dose allowed up to 600 mg BID for 12 weeks. Part B initial dosing was 400 mg QD for 2 weeks with dose escalation to 400 mg BID at the discretion of the Investigator for the purposes of investigating dose response and identifying the minimal efficacious dose of rilzabrutinib for 24 weeks. |
Inclusion Criteria: * Male or female patients, aged 18 to 80 years old, with biopsy-proven, mild-moderate PV (PDAI 8 to 45) in Part A and mild to severe PV in Part B (PDAI 8 to 60) that are either: * newly diagnosed patients (i.e. naïve to an effective induction treatment regimen) for whom an in...
PRN1008 is an investigational small molecule being studied for the treatment of Pemphigus Vulgaris, a rare autoimmune blistering skin disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its safety and efficacy in adult patients with this condition.
PRN1008 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research to evaluate the drug's potential as a treatment for Pemphigus Vulgaris, a chronic autoimmune disorder affecting the skin and mucous membranes.
PRN1008 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies for commercial use. The Phase 2 study has been completed, and the drug is being evaluated for its safety and efficacy in patients with Pemphigus Vulgaris.
PRN1008 has one completed clinical trial registered under NCT02704429, titled 'A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris.' This Phase 2 study enrolled 42 participants across Australia, Croatia, France, Greece, and Israel. The trial was uncontrolled and did not use randomization or blinding.
PRN1008 is a small molecule therapeutic being developed by Sanofi for Pemphigus Vulgaris. While the specific molecular target is not disclosed in the available information, the drug is designed to intervene in the disease process of this autoimmune condition. Further details on its mechanism of action are not provided.