WA29767 - A study of Tocilizumab versus placebo in Systemic Sclerosis
Research type
Research Study
Full title
A phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of Tocilizumab versus placebo in patients with systemic sclerosis
IRAS ID
178793
Contact name
Christopher Denton
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2015-000424-28
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
Systemic sclerosis (SSc) is a rare and devastating connective tissue disease involving the skin, underlying tissues, blood vessels, and major organs. It is characterized by microvascular damage and fibrosis of the skin and of various internal organs. Although the pathogenesis of SSc is not yet fully understood, it is believed to result from increased systemic fibrosis, vasculopathy, and immune dysfunction.
To date there are no approved treatment options and no therapy has been shown to modify overall disease progression in SSc.
WA27788, is an ongoing Phase II/III, randomized, double-blind study of patients with SSc who were treated with subcutaneous (SC) injections of Tocilizumab (TCZ) 162 mg or placebo weekly or QW. The study demonstrated a clinically meaningful effect of TCZ on modified Rodnan Skin Score (mRSS) and forced vital capacity (FVC), as well as improvements in Health Assessment Questionnaire Disability Index, Physician's Global Assessment, and Patient's Global Assessment. This Phase III study is designed to confirm clinically and statistically the findings from Study WA27788.
The primary efficacy objective for this study is to evaluate the efficacy of tocilizumab (TCZ) compared with placebo on skin sclerosis, as measured by modified Rodnan Skin Score (mRSS) at Week 48
The study consists of two periods: a 48 week, double-blind, placebo controlled period, followed by a 48-week open label treatment period. Patients will be randomized in a 1:1 ratio to receive subcutaneous (SC) injections of 162 mg of TCZ once weekly (QW) or placebo QW for 48 weeks during the double blind treatment period. During the open label treatment period, all patients will receive SC injections of 162 mg of TCZ QW for up to 48 weeks.
Approximately 210 patients will be enrolled, 17 in the UK at approximately 120 global sites, 7 in the UK.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1598
Date of REC Opinion
3 Dec 2015
REC opinion
Further Information Favourable Opinion