Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome
2 other identifiers
interventional
152
4 countries
53
Brief Summary
The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2017
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2019
CompletedResults Posted
Study results publicly available
January 22, 2020
CompletedOctober 23, 2020
October 1, 2020
1.7 years
March 31, 2017
December 19, 2019
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
Week 12
Secondary Outcomes (4)
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
Baseline; Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
Baseline; Week 12
Change From Baseline in ESSDAI at Week 24
Baseline; Week 24
Change From Baseline in ESSPRI at Week 24
Baseline; Week 24
Study Arms (4)
Lanraplenib
EXPERIMENTALLanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
Filgotinib
EXPERIMENTALFilgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
Tirabrutinib
EXPERIMENTALTirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
Placebo, then active treatment
PLACEBO COMPARATORFilgotinib placebo + lanraplenib placebo + tirabrutinib placebo for 24 weeks. Following completion of the Week 24 assessments and procedures, participants will be rerandomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48: * filgotinib + lanraplenib placebo + tirabrutinib placebo * lanraplenib + filgotinib placebo + tirabrutinib placebo * tirabrutinib + filgotinib placebo + lanraplenib placebo
Interventions
1 x 30 mg tablet administered orally once daily
1 x 200 mg tablet administered orally once daily
1 x 40 mg tablet administered orally once daily
1 x tablet administered orally once daily
1 x tablet administered orally once daily
1 x tablet administered orally once daily
Eligibility Criteria
You may qualify if:
- Diagnosed with primary or secondary SjS according to the 2002 American European Consensus Group (AECG) classification
- Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI) ≥ 5
- Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA or anti-SSB)
You may not qualify if:
- Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Galapagos NVcollaborator
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (53)
AARR Arizona Arthritis & Rheumatology Research
Mesa, Arizona, 85202, United States
AARR Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Medvin Clinical Research
Covina, California, 91723, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, 91786, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research Consultants LLC
DeBary, Florida, 32713, United States
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, 33309, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34668, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
North Georgia Rheumatology Group, PC
Lawrenceville, Georgia, 30046, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701, United States
June DO, PC
Lansing, Michigan, 48910, United States
North Mississippi Medical Clinics, Inc. - Clinical Research
Tupelo, Mississippi, 38801, United States
Clayton Medical Associates
St Louis, Missouri, 63117, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, 28451, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119, United States
Diagnostic Group Integrated Healthcare System, Pllc
Beaumont, Texas, 77701, United States
Accurate Clinical Research Inc.
Houston, Texas, 77034, United States
Southwest Rheumatology Research
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates
Plano, Texas, 75024, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, 76710, United States
Wasatch Peak Family Practice
Layton, Utah, 84041, United States
The Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320, United States
Arthritis Northwest
Spokane, Washington, 99204, United States
Centrum Kliniczno-Badawcze
Elblag, 82-300, Poland
Intermedius
Kościan, 64-000, Poland
Centrum Badan Klinicznych S.C
Poznan, 60-733, Poland
Ai Centrum Medyczne
Poznan, 61-113, Poland
Centrum Medyczne Amed Warszawa Targowek
Warsaw, 03-921, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital General Universitario De Elche
Elche, 03203, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942, Spain
Hospital Regional Universitario de Malaga
Málaga, 29009, Spain
Hospital De Merida
Mérida, 6800, Spain
Corporacio Sanitaria Parc Taulí de Sabadell
Sabadell, 08208, Spain
Hospital Clinico Universitario de Salamanca
San Vicente, 37007, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Doncaster Royal Infirmary
Doncaster, DN2 5LT, United Kingdom
Western General Hospital
Edinburgh, EX4 2XU, United Kingdom
Princess Alexandra Hospital
Harlow, CM20 1QX, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
Warrington Hospital
Warrington, WA5 1QG, United Kingdom
Related Publications (1)
Price E, Bombardieri M, Kivitz A, Matzkies F, Gurtovaya O, Pechonkina A, Jiang W, Downie B, Mathur A, Mozaffarian A, Mozaffarian N, Gottenberg JE. Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjogren's syndrome: a randomized, phase 2, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 Nov 28;61(12):4797-4808. doi: 10.1093/rheumatology/keac167.
PMID: 35377447DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 4, 2017
Study Start
May 1, 2017
Primary Completion
January 10, 2019
Study Completion
October 2, 2019
Last Updated
October 23, 2020
Results First Posted
January 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share