Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

Last updated: October 1, 2020
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT03100942
GS-US-445-4189
2016-003558-34
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosed with primary or secondary SjS according to the 2002 American EuropeanConsensus Group (AECG) classification

  • Active SjS as defined by an European League Against Rheumatism (EULAR) Sjogren'ssyndrome disease activity index (ESSDAI) ≥ 5

  • Seropositivity for antibodies to SjS-associated antigens A and/or B (anti-SSA oranti-SSB)

Exclusion

Key Exclusion Criteria:

  • Concurrent treatment with any biologic disease modifying antirheumatic drug (bDMARD) (prior bDMARD treatment allowed with appropriate washout as per study protocol) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 152
Study Start date:
May 01, 2017
Estimated Completion Date:
October 02, 2019

Connect with a study center

  • Centrum Kliniczno-Badawcze

    Elblag, 82-300
    Poland

    Site Not Available

  • Centrum Kliniczno-Badawcze

    Elbląg, 82-300
    Poland

    Site Not Available

  • Silmedic

    Katowice, 40-282
    Poland

    Site Not Available

  • Intermedius

    Koscian, Poland
    Poland

    Site Not Available

  • Intermedius

    Kościan, 64-000
    Poland

    Site Not Available

  • Ai Centrum Medyczne

    Poznan, 61-113
    Poland

    Site Not Available

  • Centrum Badan Klinicznych S.C

    Poznan, 60-733
    Poland

    Site Not Available

  • Centrum Medyczne Amed Warszawa Targowek

    Warszawa, 03-921
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Virgen De La Arrixaca

    El Palmar, 30120
    Spain

    Site Not Available

  • Hospital General Universitario De Elche

    Elche, 03203
    Spain

    Site Not Available

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, 28942
    Spain

    Site Not Available

  • Hospital Universitario de Getafe

    Getafe, 28905
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Málaga, 29009
    Spain

    Site Not Available

  • Hospital De Merida

    Mérida, 6800
    Spain

    Site Not Available

  • Corporacio Sanitaria Parc Taulí de Sabadell

    Sabadell, 08208
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Salamanca

    San Vicente, 37007
    Spain

    Site Not Available

  • Hospital Infanta Sofia

    San sebastian de los Reyes, 28702
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Hospital Quironsalud Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    Christchurch, BH23 2JX
    United Kingdom

    Site Not Available

  • Derby Teaching Hospitals NHS FT

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT
    United Kingdom

    Site Not Available

  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    Dorset, BH23 2JX
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, EX4 2XU
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Princess Alexandra Hospital

    Harlow, CM20 1QX
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Great Western Hospital

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Maidstone and Tunbridge Wells NHS Trust

    Tunbridge Wells, TN2 4AJ
    United Kingdom

    Site Not Available

  • Warrington Hospital

    Warrington, WA5 1QG
    United Kingdom

    Site Not Available

  • AARR Arizona Arthritis & Rheumatology Research

    Mesa, Arizona 85202
    United States

    Site Not Available

  • AARR Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91723
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California 91786
    United States

    Site Not Available

  • Ventura Clinical Trials

    Ventura, California 93003
    United States

    Site Not Available

  • Denver Arthritis Clinic

    Denver, Colorado 80230
    United States

    Site Not Available

  • New England Research Associates

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Omega Research Consultants LLC

    DeBary, Florida 32713
    United States

    Site Not Available

  • Center for Rheumatology Immunology and Arthritis

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • University of Florida College of Medicine, Jacksonville - Rheumatology Research

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Biotech Pharmaceutical Group

    Miami, Florida 33155
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34668
    United States

    Site Not Available

  • IRIS Research and Development, LLC

    Plantation, Florida 33324
    United States

    Site Not Available

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois 62703
    United States

    Site Not Available

  • Center for Arthritis & Osteoporosis

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • Bluegrass Community Research, Inc.

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • June DO, PC

    Lansing, Michigan 48910
    United States

    Site Not Available

  • North Mississippi Medical Clinics, Inc. - Clinical Research

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Clayton Medical Associates

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Weill Cornell Medical College

    Brooklyn, New York 11201
    United States

    Site Not Available

  • NYU Langone Orthopedic Center, Seligman Center for Advanced Therapeutic

    New York, New York 10016
    United States

    Site Not Available

  • Joint and Muscle Research Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cape Fear Arthritis Care, PLLC

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Shanahan Rheumatology and Immunotherapy, PLLC

    Raleigh, North Carolina 27617
    United States

    Site Not Available

  • PMG Research of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • East Penn Rheumatology Associates, P.C.

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLC

    Wyoming, Pennsylvania 19610
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLC

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • ACME Research, LLC

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Ramesh C. Gupta, MD

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Amarillo Center for Clinical Research

    Amarillo, Texas 79124
    United States

    Site Not Available

  • Diagnostic Group Integrated Healthcare System, Pllc

    Beaumont, Texas 77701
    United States

    Site Not Available

  • Trinity Universal Research Associates

    Carrollton, Texas 75007
    United States

    Site Not Available

  • Arthritis Centers of Texas

    Dallas, Texas 75246
    United States

    Site Not Available

  • Accurate Clinical Research Inc.

    Houston, Texas 77034
    United States

    Site Not Available

  • Southwest Rheumatology Research

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Trinity Universal Research Associates

    Plano, Texas 75024
    United States

    Site Not Available

  • Arthritis & Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

  • Wasatch Peak Family Practice

    Layton, Utah 84041
    United States

    Site Not Available

  • The Center for Arthritis and Rheumatic Diseases, PC

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Arthritis Northwest

    Spokane, Washington 99204
    United States

    Site Not Available

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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