NCT02383589

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.

Conditions

• Pemphigus Vulgaris

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil Placebo	MMF matching placebo will be administered orally Q12H.
DRUG	Mycophenolate Mofetil	MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.
DRUG	Rituximab	Rituximab will be administered at a dose of 1000 mg via IV infusion.
DRUG	Rituximab Placebo	Rituximab matching placebo will be administered via IV infusion.

Timeline

• Start date: 2015-05-26
• Primary completion: 2018-11-28
• Completion: 2019-10-29
• First posted: 2015-03-09
• Last updated: 2020-11-10
• Results posted: 2020-01-18

Locations

68 sites across 12 countries: United States, Argentina, Australia, Brazil, Canada, France, Germany, Israel, Italy, Spain, Turkey (Türkiye), Ukraine