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

Sponsoren

Hauptsponsor: Gilead Sciences

Mitarbeiter: Galapagos NV

Quelle Gilead Sciences
Kurze Zusammenfassung

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).

Gesamtstatus Completed
Anfangsdatum May 1, 2017
Fertigstellungstermin October 2, 2019
Primäres Abschlussdatum January 10, 2019
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline Week 12
Sekundäres Ergebnis
Messen Zeitfenster
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
Einschreibung 152
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Filgotinib

Beschreibung: 1x 200 mg tablet administered orally once daily

Anderer Name: GS-6034

Interventionsart: Drug

Interventionsname: Lanraplenib

Beschreibung: 1x 30 mg tablet administered orally once daily

Anderer Name: GS-9876

Interventionsart: Drug

Interventionsname: Tirabrutinib

Beschreibung: 1x 40 mg tablet administered orally once daily

Anderer Name: GS-4059

Interventionsart: Drug

Interventionsname: Filgotinib placebo

Beschreibung: 1x tablet administered orally once daily

Interventionsart: Drug

Interventionsname: Lanraplenib placebo

Beschreibung: 1x tablet administered orally once daily

Interventionsart: Drug

Interventionsname: Tirabrutinib placebo

Beschreibung: 1x tablet administered orally once daily

Teilnahmeberechtigung

Kriterien:

Key Inclusion Criteria:

- 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)

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.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Gilead Study Director Study Director Gilead Sciences
Ort
Einrichtung:
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 | Saint 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 | Elbląg, 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 | Warszawa, 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 | Sevilla, 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
Standort Länder

Poland

Spain

United Kingdom

United States

Überprüfungsdatum

January 2020

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 4
Armgruppe

Etikette: Filgotinib

Art: Experimental

Beschreibung: Filgotinib + lanraplenib placebo + tirabrutinib placebo for 48 weeks

Etikette: Lanraplenib

Art: Experimental

Beschreibung: Lanraplenib + filgotinib placebo + tirabrutinib placebo for 48 weeks

Etikette: Tirabrutinib

Art: Experimental

Beschreibung: Tirabrutinib + filgotinib placebo + lanraplenib placebo for 48 weeks

Etikette: Placebo, then active treatment

Art: Placebo Comparator

Beschreibung: 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

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov