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

Roche

Status and phase: Completed; Phase 3

Conditions: Systemic Sclerosis

Treatments: Drug: Tocilizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453256

WA29767

2015-000424-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (</=) 60 months
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 2 patient groups, including a placebo group

Double-Blind Placebo

Placebo Comparator group

Description:

Participants will receive double-blind matching placebo from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.

Treatment:

Drug: Tocilizumab

Drug: Placebo

Double-Blind Tocilizumab

Experimental group

Description:

Participants will receive double-blind tocilizumab from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.

Treatment:

Drug: Tocilizumab