A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

• Status: Completed
• Trial end date: 2019-02-04
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Diagnosis of SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and with total disease duration of less than or equal to (
• mRSS of 10-35 units, inclusive

• Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential

Exclusion Criteria:

• Pregnant or lactating females

• Major surgery within 8 weeks prior to screening

• Scleroderma limited to the face or areas distal to the elbows or knees

• Rheumatic autoimmune disease other than SSc

• Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline

• Known hypersensitivity to human, humanized, or murine monoclonal antibodies

• Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or gastrointestinal (GI) disease not related to SSc, including diverticulitis or ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to screening

• Active or significant history of infection, including treatment with intravenous (IV) antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening

• Significant history of tuberculosis (TB)

• Primary or secondary immunodeficiency

• Malignant disease, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix

• History of drug or alcohol abuse