A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

Roche

Status and phase

Completed

Phase 2

Conditions

Sjogren's Syndrome

Treatments

Drug: Placebo

Drug: RO5459072

Study type

Interventional

Funder types

Industry

Identifiers

NCT02701985

2015-004476-30 (EudraCT Number)

BP30037

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).

Enrollment

75 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
ESSDAI score greater than or equal to (>/=) 5
ESSPRI score >/=5
Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
Negative pregnancy test at screening and baseline (for women only)
Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation

Exclusion criteria

A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
Severe complications of Sjogren's syndrome
Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
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 screening
A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
A diagnosis of fibromyalgia or significant depression
Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
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, breastfeeding or planning to nurse
Using 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)