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

October 1, 2020 updated by: Gilead Sciences

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Elbląg, Poland, 82-300
        • Centrum Kliniczno-Badawcze
      • Kościan, Poland, 64-000
        • Intermedius
      • Poznan, Poland, 61-113
        • AI Centrum Medyczne
      • Poznan, Poland, 60-733
        • Centrum Badan Klinicznych S.C
      • Warszawa, Poland, 03-921
        • Centrum Medyczne AMED Warszawa Targowek
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporów
  • Spain
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau
      • Elche, Spain, 03203
        • Hospital General Universitario de Elche
      • Fuenlabrada, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Málaga, Spain, 29009
        • Hospital Regional Universitario de Málaga
      • Mérida, Spain, 6800
        • Hospital de Merida
      • Sabadell, Spain, 08208
        • Corporació Sanitària Parc Taulí de Sabadell
      • San Vicente, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
      • Sevilla, Spain, 41010
        • Hospital Quironsalud Infanta Luisa
  • United Kingdom
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Edinburgh, United Kingdom, EX4 2XU
        • Western General Hospital
      • Harlow, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Warrington, United Kingdom, WA5 1QG
        • Warrington Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • AARR Arizona Arthritis & Rheumatology Research
      • Phoenix, Arizona, United States, 85032
        • AARR Arizona Arthritis & Rheumatology Research
    • California
      • Covina, California, United States, 91723
        • Medvin Clinical Research
      • Upland, California, United States, 91786
        • Inland Rheumatology Clinical Trials, Inc.
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants LLC
      • Fort Lauderdale, Florida, United States, 33309
        • Center for Rheumatology Immunology and Arthritis
      • New Port Richey, Florida, United States, 34668
        • Suncoast Clinical Research, Inc.
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • North Georgia Rheumatology Group, PC
    • Illinois
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Center for Arthritis & Osteoporosis
    • Michigan
      • Lansing, Michigan, United States, 48910
        • June DO, PC
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Clinics, Inc. - Clinical Research
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Clayton Medical Associates
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Joint and Muscle Research Institute
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care, PLLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • East Penn Rheumatology Associates, P.C.
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Center of Reading, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch
      • Memphis, Tennessee, United States, 38119
        • Ramesh C. Gupta, MD
    • Texas
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group Integrated Healthcare System, Pllc
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research Inc.
      • Mesquite, Texas, United States, 75150
        • SouthWest Rheumatology Research
      • Plano, Texas, United States, 75024
        • Trinity Universal Research Associates
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic
    • Utah
      • Layton, Utah, United States, 84041
        • Wasatch Peak Family Practice
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • The Center for Arthritis and Rheumatic Diseases, PC
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lanraplenib
Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
Drug: Lanraplenib
1 x 30 mg tablet administered orally once daily
Other Names:
  • GS-9876
Drug: Filgotinib placebo
1 x tablet administered orally once daily
Drug: Tirabrutinib placebo
1 x tablet administered orally once daily
Experimental: Filgotinib
Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
Drug: Tirabrutinib placebo
1 x tablet administered orally once daily
Drug: Filgotinib
1 x 200 mg tablet administered orally once daily
Other Names:
  • GS-6034
Drug: Lanraplenib placebo
1 x tablet administered orally once daily
Experimental: Tirabrutinib
Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
Drug: Filgotinib placebo
1 x tablet administered orally once daily
Drug: Lanraplenib placebo
1 x tablet administered orally once daily
Drug: Tirabrutinib
1 x 40 mg tablet administered orally once daily
Other Names:
  • GS-4059
Placebo Comparator: 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
Drug: Lanraplenib
1 x 30 mg tablet administered orally once daily
Other Names:
  • GS-9876
Drug: Filgotinib placebo
1 x tablet administered orally once daily
Drug: Tirabrutinib placebo
1 x tablet administered orally once daily
Drug: Filgotinib
1 x 200 mg tablet administered orally once daily
Other Names:
  • GS-6034
Drug: Lanraplenib placebo
1 x tablet administered orally once daily
Drug: Tirabrutinib
1 x 40 mg tablet administered orally once daily
Other Names:
  • GS-4059

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Time Frame: Week 12
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).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
Time Frame: Baseline; 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.
Baseline; Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
Time Frame: Baseline; 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.
Baseline; Week 12
Change From Baseline in ESSDAI at Week 24
Time Frame: Baseline; 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.
Baseline; Week 24
Change From Baseline in ESSPRI at Week 24
Time Frame: Baseline; 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.
Baseline; Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ono Pharmaceutical Co. Ltd
Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-445-4189
  • 2016-003558-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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