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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03100942
• Date of registration: 31/03/2017
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
• Scientific 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
• Date of first enrolment: May 1, 2017
• Target sample size: 152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03100942
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Poland, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: Filgotinib

Drug: Tirabrutinib

Drug: Filgotinib placebo

Drug: Lanraplenib

Drug: Tirabrutinib placebo

Drug: Lanraplenib placebo

Primary Outcome(s)

Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in ESSDAI at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in ESSPRI at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12 [Time Frame: Baseline; Week 12]

Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12 [Time Frame: Baseline; Week 12]

Secondary ID(s)

2016-003558-34

GS-US-445-4189

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Galapagos NV

Results

• Results available: Yes
• Date Posted: 22/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03100942