Clinical trial NCT03100942: Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sjogren's Syndrome
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
name: Ono Pharmaceutical Co. Ltd
First posted: 2017-04-04
Enrollment: 152
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: 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: 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.

Primary outcomes:
measure: Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in ESSDAI at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in ESSPRI at Week 24
timeFrame: Baseline; Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: AARR Arizona Arthritis & Rheumatology Research
state: Arizona
city: Phoenix
country: United States
facility: AARR Arizona Arthritis & Rheumatology Research
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology Immunology and Arthritis
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group, PC
state: Georgia
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Elizabethtown
country: United States
facility: Center for Arthritis & Osteoporosis
state: Kentucky
city: Lansing
country: United States
facility: June DO, PC
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Clinics, Inc. - Clinical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Clayton Medical Associates
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care, PLLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, P.C.
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C. Gupta, MD
state: Tennessee
city: Beaumont
country: United States
facility: Diagnostic Group Integrated Healthcare System, Pllc
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research Inc.
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
city: Layton
country: United States
facility: Wasatch Peak Family Practice
state: Utah
city: Chesapeake
country: United States
facility: The Center for Arthritis and Rheumatic Diseases, PC
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Elbląg
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Kościan
country: Poland
facility: Intermedius
city: Poznan
country: Poland
facility: Centrum Badan Klinicznych S.C
city: Poznan
country: Poland
facility: Ai Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Medyczne Amed Warszawa Targowek
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Elche
country: Spain
facility: Hospital General Universitario De Elche
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Mérida
country: Spain
facility: Hospital De Merida
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Taulí de Sabadell
city: San Vicente
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Warrington
country: United Kingdom
facility: Warrington Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.