Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
NCT ID: NCT03100942
Last Updated: 2020-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2017-05-01
2019-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lanraplenib
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
Lanraplenib
1 x 30 mg tablet administered orally once daily
Filgotinib placebo
1 x tablet administered orally once daily
Tirabrutinib placebo
1 x tablet administered orally once daily
Filgotinib
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
Filgotinib
1 x 200 mg tablet administered orally once daily
Lanraplenib placebo
1 x tablet administered orally once daily
Tirabrutinib placebo
1 x tablet administered orally once daily
Tirabrutinib
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
Tirabrutinib
1 x 40 mg tablet administered orally once daily
Lanraplenib placebo
1 x tablet administered orally once daily
Filgotinib placebo
1 x tablet administered orally once daily
Placebo, then active treatment
Filgotinib 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
Lanraplenib
1 x 30 mg tablet administered orally once daily
Filgotinib
1 x 200 mg tablet administered orally once daily
Tirabrutinib
1 x 40 mg tablet administered orally once daily
Lanraplenib placebo
1 x tablet administered orally once daily
Filgotinib placebo
1 x tablet administered orally once daily
Tirabrutinib placebo
1 x tablet administered orally once daily
Interventions
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Lanraplenib
1 x 30 mg tablet administered orally once daily
Filgotinib
1 x 200 mg tablet administered orally once daily
Tirabrutinib
1 x 40 mg tablet administered orally once daily
Lanraplenib placebo
1 x tablet administered orally once daily
Filgotinib placebo
1 x tablet administered orally once daily
Tirabrutinib placebo
1 x tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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AARR Arizona Arthritis & Rheumatology Research
Mesa, Arizona, United States
AARR Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, United States
Medvin Clinical Research
Covina, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Omega Research Consultants LLC
DeBary, Florida, United States
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
IRIS Research and Development, LLC
Plantation, Florida, United States
North Georgia Rheumatology Group, PC
Lawrenceville, Georgia, United States
Springfield Clinic
Springfield, Illinois, United States
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, United States
June DO, PC
Lansing, Michigan, United States
North Mississippi Medical Clinics, Inc. - Clinical Research
Tupelo, Mississippi, United States
Clayton Medical Associates
St Louis, Missouri, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, United States
Cape Fear Arthritis Care, PLLC
Leland, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
ClinSearch
Chattanooga, Tennessee, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Diagnostic Group Integrated Healthcare System, Pllc
Beaumont, Texas, United States
Accurate Clinical Research Inc.
Houston, Texas, United States
Southwest Rheumatology Research
Mesquite, Texas, United States
Trinity Universal Research Associates
Plano, Texas, United States
Arthritis & Osteoporosis Clinic
Waco, Texas, United States
Wasatch Peak Family Practice
Layton, Utah, United States
The Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States
Arthritis Northwest
Spokane, Washington, United States
Centrum Kliniczno-Badawcze
Elblag, , Poland
Intermedius
Kościan, , Poland
Centrum Badan Klinicznych S.C
Poznan, , Poland
Ai Centrum Medyczne
Poznan, , Poland
Centrum Medyczne Amed Warszawa Targowek
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario De Elche
Elche, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital De Merida
Mérida, , Spain
Corporacio Sanitaria Parc Taulí de Sabadell
Sabadell, , Spain
Hospital Clinico Universitario de Salamanca
San Vicente, , Spain
Hospital Quironsalud Infanta Luisa
Seville, , Spain
Doncaster Royal Infirmary
Doncaster, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Princess Alexandra Hospital
Harlow, , United Kingdom
Great Western Hospital
Swindon, , United Kingdom
Warrington Hospital
Warrington, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003558-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-445-4189
Identifier Type: -
Identifier Source: org_study_id
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