Genentech announced it has begun a phase 3 clinical study of Rituxan in patients with pemphigus vulgaris.
The clinical trial’s goal is to determine efficacy and safety of Rituxan (rituximab) for treating pemphigus vulgaris, a rare, chronic and potentially fatal blistering skin disease that primarily occurs in adults aged 30 to 60 years, according to a company announcement. The FDA has granted orphan drug designation for rituximab for treating pemphigus vulgaris, according to the announcement. If approved, it would be the first FDA-approved biologic for treating the autoimmune disease.
The phase 3, randomized, double-blind, multicenter, international study will evaluate the efficacy and safety of rituximab compared with mycophenolate mofetil in approximately 124 patients with moderate-to-severely active pemphigus vulgaris, according to the announcement. Patients will receive 1,000 mg IV rituximab on days 1 and 15, with repeat dosage on days 168 and 182, provided specific safety criteria have been met, the company announced. Mycophenolate mofetil dosage will be 1 g given orally in divided doses at start, with the dose increased gradually to 1 g twice daily, according to the announcement.
High doses of corticosteroids taken for several weeks and corticosteroids in combination with off-label use of corticosteroid-sparing immunosuppressive drugs is the current standard of care for patients with pemphigus vulgaris. Rituximab therapy might result in substantial improvement in remission rates and tapering and/or cessation of corticosteroid therapy, according to independent study results, according to the announcement.
“Current treatments for pemphigus vulgaris can cause significant, long-term side effects,” Victoria P. Werth, MD, professor of dermatology and medicine at the University of Pennsylvania, and lead trial investigator, said in a statement.
Rituximab is approved for treating rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, according to the announcement.