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

Primary Purpose

Sjogren's Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lanraplenib
Filgotinib
Tirabrutinib
Lanraplenib placebo
Filgotinib placebo
Tirabrutinib placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sjogren's Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AARR Arizona Arthritis & Rheumatology Research
  • AARR Arizona Arthritis & Rheumatology Research
  • Medvin Clinical Research
  • Inland Rheumatology Clinical Trials, Inc.
  • Denver Arthritis Clinic
  • Clinical Research of West Florida, Inc.
  • Omega Research Consultants LLC
  • Center for Rheumatology Immunology and Arthritis
  • Suncoast Clinical Research, Inc.
  • IRIS Research and Development, LLC
  • North Georgia Rheumatology Group, PC
  • Springfield Clinic
  • Center for Arthritis & Osteoporosis
  • June DO, PC
  • North Mississippi Medical Clinics, Inc. - Clinical Research
  • Clayton Medical Associates
  • Physician Research Collaboration, LLC
  • Albuquerque Clinical Trials
  • Joint and Muscle Research Institute
  • Cape Fear Arthritis Care, PLLC
  • PMG Research of Salisbury
  • East Penn Rheumatology Associates, P.C.
  • Altoona Center for Clinical Research
  • Clinical Research Center of Reading, LLC
  • ClinSearch
  • Ramesh C. Gupta, MD
  • Diagnostic Group Integrated Healthcare System, Pllc
  • Accurate Clinical Research Inc.
  • Southwest Rheumatology Research
  • Trinity Universal Research Associates
  • Arthritis & Osteoporosis Clinic
  • Wasatch Peak Family Practice
  • The Center for Arthritis and Rheumatic Diseases, PC
  • Arthritis Northwest
  • Centrum Kliniczno-Badawcze
  • Intermedius
  • Centrum Badan Klinicznych S.C
  • Ai Centrum Medyczne
  • Centrum Medyczne Amed Warszawa Targowek
  • Centrum Medyczne Oporow
  • Hospital de la Santa Creu i Sant Pau
  • Hospital General Universitario De Elche
  • Hospital Universitario de Fuenlabrada
  • Hospital Regional Universitario de Malaga
  • Hospital De Merida
  • Corporacio Sanitaria Parc Taulí de Sabadell
  • Hospital Clinico Universitario de Salamanca
  • Hospital Quironsalud Infanta Luisa
  • Doncaster Royal Infirmary
  • Western General Hospital
  • Princess Alexandra Hospital
  • Great Western Hospital
  • Warrington Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Lanraplenib

Filgotinib

Tirabrutinib

Placebo, then active treatment

Arm Description

Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.

Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.

Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Change From Baseline in ESSDAI at Week 24
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Change From Baseline in ESSPRI at Week 24
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.

Full Information

First Posted
March 31, 2017
Last Updated
October 1, 2020
Sponsor
Gilead Sciences
Collaborators
Galapagos NV, Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03100942
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Galapagos NV, Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lanraplenib
Arm Type
Experimental
Arm Description
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
Arm Title
Filgotinib
Arm Type
Experimental
Arm Description
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
Arm Title
Tirabrutinib
Arm Type
Experimental
Arm Description
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
Arm Title
Placebo, then active treatment
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Lanraplenib
Other Intervention Name(s)
GS-9876
Intervention Description
1 x 30 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Other Intervention Name(s)
GS-6034
Intervention Description
1 x 200 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Tirabrutinib
Other Intervention Name(s)
GS-4059
Intervention Description
1 x 40 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Lanraplenib placebo
Intervention Description
1 x tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Filgotinib placebo
Intervention Description
1 x tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Tirabrutinib placebo
Intervention Description
1 x tablet administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Description
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).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
Description
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Time Frame
Baseline; Week 12
Title
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
Description
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Time Frame
Baseline; Week 12
Title
Change From Baseline in ESSDAI at Week 24
Description
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Time Frame
Baseline; Week 24
Title
Change From Baseline in ESSPRI at Week 24
Description
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Time Frame
Baseline; Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
AARR Arizona Arthritis & Rheumatology Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
AARR Arizona Arthritis & Rheumatology Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Omega Research Consultants LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Center for Rheumatology Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34668
Country
United States
Facility Name
IRIS Research and Development, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
North Georgia Rheumatology Group, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Center for Arthritis & Osteoporosis
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
June DO, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
North Mississippi Medical Clinics, Inc. - Clinical Research
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Clayton Medical Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Joint and Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Cape Fear Arthritis Care, PLLC
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
East Penn Rheumatology Associates, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading, LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Diagnostic Group Integrated Healthcare System, Pllc
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Accurate Clinical Research Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Southwest Rheumatology Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
The Center for Arthritis and Rheumatic Diseases, PC
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Centrum Kliniczno-Badawcze
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Intermedius
City
Kościan
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Centrum Badan Klinicznych S.C
City
Poznan
ZIP/Postal Code
60-733
Country
Poland
Facility Name
Ai Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Centrum Medyczne Amed Warszawa Targowek
City
Warszawa
ZIP/Postal Code
03-921
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Universitario De Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hospital De Merida
City
Mérida
ZIP/Postal Code
6800
Country
Spain
Facility Name
Corporacio Sanitaria Parc Taulí de Sabadell
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
San Vicente
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Doncaster Royal Infirmary
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EX4 2XU
Country
United Kingdom
Facility Name
Princess Alexandra Hospital
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Warrington Hospital
City
Warrington
ZIP/Postal Code
WA5 1QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35377447
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.
Results Reference
derived

Learn more about this trial

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

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