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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Sjogren's Syndrome

Treatments: Drug: Tirabrutinib placebo; Drug: Lanraplenib placebo; Drug: Lanraplenib; Drug: Tirabrutinib; Drug: Filgotinib; Drug: Filgotinib placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03100942

GS-US-445-4189

2016-003558-34 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 4 patient groups, including a placebo group

Lanraplenib

Experimental group

Description:

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

Treatment:

Drug: Filgotinib placebo

Drug: Lanraplenib

Drug: Tirabrutinib placebo

Filgotinib

Experimental group

Description:

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

Treatment:

Drug: Lanraplenib placebo

Drug: Filgotinib

Drug: Tirabrutinib placebo

Tirabrutinib

Experimental group

Description:

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

Treatment:

Drug: Lanraplenib placebo

Drug: Filgotinib placebo

Drug: Tirabrutinib

Placebo, then active treatment

Placebo Comparator group

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

Treatment:

Drug: Lanraplenib placebo

Drug: Filgotinib placebo

Drug: Filgotinib

Drug: Tirabrutinib

Drug: Lanraplenib

Drug: Tirabrutinib placebo