Clinical trial NCT02701985: A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score
timeFrame: 12 weeks
measure: Change From Baseline in ESSDAI Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in ESSPRI Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in SF-36 Physical Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in ESSPRI Dryness Component Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in ESSPRI Fatigue Component Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12
timeFrame: Baseline (Week -1), Week 12
measure: Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12
timeFrame: Baseline, Week 2, Week 6, and Week 12
measure: Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12
timeFrame: Baseline, Week 2, Week 6, and Week 12
measure: Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12
timeFrame: Baseline, Week 6, and Week 12
measure: Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12
timeFrame: Baseline, Week 6, and Week 12
measure: Change From Baseline in Rheumatoid Factor at Weeks 6, and 12
timeFrame: Baseline, Week 6, and Week 12
measure: Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12
timeFrame: Baseline, Week 6, and Week 12
measure: Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12
timeFrame: Baseline, Week 6, and Week 12
measure: Minimum Concentration (Cmin) of RO5459072
timeFrame: Week 2, Week 6, and Week 12
measure: Maximum Concentration (Cmax) of RO5459072
timeFrame: Week 2, Week 6, and Week 12
measure: Average Concentration (Caverage) of RO5459072
timeFrame: Week 2, Week 6, and Week 12
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to Week 14
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins Bayview Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunology, PLLC
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Memphis
country: United States
facility: Ramesh Gupta - PP
state: Tennessee
city: Bobigny
country: France
facility: Hopital Avicenne, Paris
city: Boulogne Billancourt
country: France
facility: C.H.U. Ambroise Pare (AP-HP)
city: Brest
country: France
facility: Hopital La Cavale Blanche; Rhumatologie
city: Montpellier
country: France
facility: Hopital Lapeyronie; Immunologie Rhumatologie
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
city: Poznan
country: Poland
facility: MedPolonia
city: Warszawa
country: Poland
facility: Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Lisboa
country: Portugal
facility: Instituto Portugues de Reumatologia
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto - Hospital de Santo António
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao,E.P.E.
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
city: Wiltshire
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: