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

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ClinicalTrials.gov Identifier: NCT03100942
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : January 22, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Galapagos NV
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 4, 2017
Results First Submitted Date  ICMJE December 19, 2019
Results First Posted Date  ICMJE January 22, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
Proportion of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline [ Time Frame: Week 12 ]
Response is defined in the protocol as composite improvement of biologic and patient reported outcomes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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.
  • Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12 [ Time Frame: Baseline; Week 12 ]
    The ESSPRI is a patient-reported questionnaire to assess subjective patient symptoms and includes 3 domains (dryness, pain, and fatigue).
  • 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.
  • Change From Baseline in ESSPRI at Week 24 [ Time Frame: Baseline; Week 24 ]
    The ESSPRI is a patient-reported questionnaire to assess subjective patient symptoms and includes 3 domains (dryness, pain, and fatigue).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sjogren's Syndrome
Intervention  ICMJE
  • Drug: Lanraplenib
    1 x 30 mg tablet administered orally once daily
    Other Name: GS-9876
  • Drug: Filgotinib
    1 x 200 mg tablet administered orally once daily
    Other Name: GS-6034
  • Drug: Tirabrutinib
    1 x 40 mg tablet administered orally once daily
    Other Name: GS-4059
  • Drug: Lanraplenib placebo
    1 x tablet administered orally once daily
  • Drug: Filgotinib placebo
    1 x tablet administered orally once daily
  • Drug: Tirabrutinib placebo
    1 x tablet administered orally once daily
Study Arms  ICMJE
  • Experimental: Lanraplenib
    Lanraplenib + filgotinib placebo + tirabrutinib placebo for up to 49.4 weeks.
    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib placebo
    • Drug: Tirabrutinib placebo
  • Experimental: Filgotinib
    Filgotinib + lanraplenib placebo + tirabrutinib placebo for up to 50.4 weeks.
    Interventions:
    • Drug: Filgotinib
    • Drug: Lanraplenib placebo
    • Drug: Tirabrutinib placebo
  • Experimental: Tirabrutinib
    Tirabrutinib + filgotinib placebo + lanraplenib placebo for up to 50.3 weeks.
    Interventions:
    • Drug: Tirabrutinib
    • Drug: Lanraplenib placebo
    • Drug: Filgotinib placebo
  • 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
    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib
    • Drug: Tirabrutinib
    • Drug: Lanraplenib placebo
    • Drug: Filgotinib placebo
    • Drug: Tirabrutinib placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2018)
152
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
140
Actual Study Completion Date  ICMJE October 2, 2019
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100942
Other Study ID Numbers  ICMJE GS-US-445-4189
2016-003558-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE
  • Galapagos NV
  • Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP