GSK’s Stiefel begins subcutaneous ofatumumab Phase III trial for pemphigus vulgaris

7th October 2014 (Last Updated October 7th, 2014 18:30)

British drug maker GlaxoSmithKline’s (GSK) subsidiary Stiefel has commenced Phase III trial to assess the efficacy and safety of subcutaneous ofatumumab in patients with a rare autoimmune skin disorder, pemphigus vulgaris.

GSK

British drug maker GlaxoSmithKline's (GSK) subsidiary Stiefel has commenced Phase III trial to assess the efficacy and safety of subcutaneous ofatumumab in patients with a rare autoimmune skin disorder, pemphigus vulgaris.

Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule, and encompasses parts of the small and large extracellular loops.

Stiefel senior vice-president and R&D head 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."

Ofatumumab is being developed, as a result of the co-development and collaboration agreement between Genmab and GSK.

The trial is said to evaluate disease remission in patients with pemphigus vulgaris treated with subcutaneous ofatumumab as add-on treatment to oral steroids.

The randomised, double-blind, placebo-controlled, parallel-group trial, following treatment with subcutaneous ofatumumab as add-on treatment to oral steroids, will be compared against control arm receiving placebo as add-on treatment.

For a total of 56 weeks, ofatumumab will be administered at a dose of 20mg, every four weeks.

For a total of 56 weeks, ofatumumab will be administered at a dose of 20mg, every four weeks.

The study will also assess the safety, tolerability, B-cell depletion and repletion, anti-desmoglein antibody levels, immunogenicity and pharmacokinetics, as well as other clinical and quality of life endpoints.

Currently, Ofatumumab has not received approval in any part of the world for pemphigus vulgaris.

Pemphigus vulgaris is a chronic skin disorder in which immune system malfunctions and produces antibodies, which attack healthy cells in the skin and mucous membranes.


Image: Low magnification micrograph of pemphigus vulgaris. Photo: courtesy of Nephron.