drugset / Trial / NCT04128176
Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the efficacy of rituximab combined with omalizumab in achieving sustained complete remission, evaluated by Bullous Pemphigoid Disease Area Index (BPDAI) in patients with bullous pemphigoid (BP) at Week 24 in patients with active moderate-to-severe BP refractory to rituximab therapy alone.
Timeline
- Start
- 2017-03
- Primary completion
- 2023-05-25
- Completion
- 2023-11-25
Publications
- Background Ujiie H, Nishie W, Shimizu H. Pathogenesis of bullous pemphigoid. Dermatol Clin. 2011 Jul;29(3):439-46, ix. doi: 10.1016/j.det.2011.03.008.
- Background Maglie R, Hertl M. Pharmacological advances in pemphigoid. Curr Opin Pharmacol. 2019 Jun;46:34-43. doi: 10.1016/j.coph.2018.12.007. Epub 2019 Feb 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Omalizumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |