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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sjogren's Syndrome

In brief

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).

Key facts

Study ID

NCT02701985

Run by

Hoffmann-La Roche

People needed

75

Starts

2016-07-05

Expected to finish

2017-07-10

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Wallace Rheumatic Study Center — Beverly Hills, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
• John Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• University Of Michigan — Ann Arbor, Michigan, United States
• Winthrop University Hospital — Mineola, New York, United States
• Shanahan Rheumatology & Immunology, PLLC — Raleigh, North Carolina, United States
• MetroHealth System — Cleveland, Ohio, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Clinical Research Center of Reading — Wyomissing, Pennsylvania, United States
• Ramesh Gupta - PP — Memphis, Tennessee, United States
• Hopital Avicenne, Paris — Bobigny, France
• C.H.U. Ambroise Pare (AP-HP) — Boulogne-Billancourt, France
• Hopital La Cavale Blanche; Rhumatologie — Brest, France
• Hopital Lapeyronie; Immunologie Rhumatologie — Montpellier, France
• Charité Research Organisation GmbH — Berlin, Germany
• Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob — Bydgoszcz, Poland
• MedPolonia — Poznan, Poland
• Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum. — Warsaw, Poland
• Centrum Medyczne AMED — Warsaw, Poland
• Instituto Portugues de Reumatologia — Lisbon, Portugal
• Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria — Lisbon, Portugal
• Centro Hospitalar do Porto - Hospital de Santo António — Porto, Portugal
• Centro Hospitalar de Sao Joao,E.P.E. — Porto, Portugal

Full record on ClinicalTrials.gov

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