A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

-Males and females 18 to 75 years of age
-Primary Sjögren's syndrome diagnosed previously according to the revised American-European Consensus Group (AECG) criteria
-European League against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score >= 5
-EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score >= 5
-Elevated serum titres at screening of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and/or anti-SSB antibodies at screening
-Negative pregnancy test at screening and baseline, and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-A diagnosis of secondary Sjögren's syndrome according to the revised
AECG criteria
-Severe complications of Sjögren's syndrome, such as vasculitis with
renal, neurologic or cardiac involvement; interstitial lung disease and
severe myositis
-Systemic immunosuppressant therapy, cyclophosphamide or B cell
depleting therapy within 6 months prior to the screening visit. Low dose
methotrexate treatment is, however, permitted
-Corticosteroid therapy exceeding 7.5 milligram (mg) prednisone
equivalents per day
-Mechanically stimulated whole salivary flow rate at baseline of < 0.1
millilitre/minute (mL/min)
-A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human
immunodeficiency virus (HIV), or tuberculosis, or any other active viral,
fungal, yeast or bacterial infection at the screening visit
-A history of recurring or chronic infections, any other indication of
reduced immune function, or any other underlying conditions which may
predispose participants to serious infection
-A history of lymphoma, myeloma (monoclonal
hypergammaglobulinemia) or monoclonal gammopathy of unknown
significance (MGUS), or any other malignancies within the past 5 years
(except basal cell or squamous cell carcinoma of the skin that has been
cured)
-A diagnosis of fibromyalgia, or a diagnosis of significant depression or
anxiety that would confound the interpretation of the study results
-Severe renal impairment, moderate or severe hepatic impairment or
other clinically significant hepatic disease
-Any other concomitant disease or condition or any clinically significant
finding that could interfere with the conduct of the study, or pose an
unacceptable risk to the individual in this study
-Participation in an investigational drug or device study within 3 months
prior to screening
-Inability to comply with the study protocol for any other reason
-Women who are lactating.
-Use of other prohibited medication (moderate or potent inhibitors of
CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter
P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow
therapeutic index).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To investigate the effects of RO5459072 treatment on disease activity and symptoms of primary Sjögren’s syndrome;Secondary Objective: 1.To investigate the effects of RO5459072 treatment on quality of life measures, auto-antibody concentrations, and pharmacodynamic measures of exocrine gland function<br>2.To collect samples for population modelling of RO5459072 pharmacokinetics<br>3.To investigate the safety and tolerability of RO5459072 treatment<br>;Primary end point(s): 1.Proportion of participants showing a clinically relevant decrease in the ESSDAI score from baseline after 12 weeks;Timepoint(s) of evaluation of this end point: 1.Week 12

Secondary Outcome Measures

Name	Time	Method

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Updated 6/27/2016