GSK’s Stiefel begins Phase III trial of subcutaneous ofatumumab to treat pemphigus vulgaris

The global, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate disease remission in these patients treated with subcutaneous ofatumumab as add-on treatment to oral steroids.

In Pemphigus vulgaris, the immune system malfunctions and produces antibodies that attack healthy cells in the skin and mucous membranes.

Patients with this disease develop burn-like blisters, which can first appear in the mouth and then on the skin.

The disease, which typically occurs between the ages of 30 to 60 years, can lead to secondary skin infections, dehydration, spread of infection through the blood (sepsis) and death.

Stiefel senior vice-president and head of R&D Dr Kathy Rouan said: "The initiation of this study is an important step towards providing a potential new treatment option for patients suffering from this painful and potentially debilitating skin disease."

The trial’s primary objective is to determine disease remission after treatment with subcutaneous ofatumumab as add-on treatment to oral steroids compared to a control arm receiving placebo.

During the trial, subcutaneous ofatumumab will be administered at a dose of 20mg every four weeks for a total of 56 weeks.

Secondary objectives of the trial include evaluation of safety, tolerability, B-cell depletion and repletion, anti-desmoglein antibody levels, immunogenicity, pharmacokinetics, and other clinical and quality of life endpoints.

Image: Stiefel Global Headquarters at Research Triangle Park, North Carolina 27709, USA. Photo: courtesy of Chzz.