Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
NCT03100942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2020-10-23
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).
Conditions
- Sjogren's Syndrome
Interventions
- DRUG
-
Lanraplenib
1 x 30 mg tablet administered orally once daily
- DRUG
-
Filgotinib
1 x 200 mg tablet administered orally once daily
- DRUG
-
1 x 40 mg tablet administered orally once daily
- 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
Sponsors & Collaborators
-
Galapagos NV
collaborator INDUSTRY -
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2019-01-10
- Completion
- 2019-10-02
- FDA Drug
- Yes
Countries
- United States
- Poland
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
NCT05349214 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome
NCT05087589 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
NCT02915159 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease
NCT05119920 ·Status: COMPLETED ·Phase: PHASE2
-
Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome
NCT03226444 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber
NCT05102409 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
NCT06684847 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
R-2487 in Patients With Sjogren's Syndrome (SS)
NCT06297213 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
NCT05350072 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
NCT04030962 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity
NCT06979531 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
NCT05695417 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
NCT06291194 ·Status: RECRUITING ·Phase: PHASE3
-
A Randomized, Parallel-Group Comparison Study of Topical Corticosteroids in Dry Eye Patients With Sjögren Syndrome
NCT02011776 ·Status: COMPLETED
-
RHPRG4 FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
NCT06520202 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
NCT01743729 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
NCT04496960 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
NCT07281456 ·Status: RECRUITING ·Phase: PHASE2
-
LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients
NCT03140111 ·Status: UNKNOWN ·Phase: NA
-
A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
NCT00852839 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome
NCT02067910 ·Status: COMPLETED ·Phase: PHASE3
-
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
NCT07118241 ·Status: RECRUITING ·Phase: PHASE2
-
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
NCT04819269 ·Status: COMPLETED ·Phase: PHASE3
-
Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
NCT05383677 ·Status: UNKNOWN ·Phase: PHASE2
-
Levocarnitine for Dry Eye in Sjogren's Syndrome
NCT03953703 ·Status: COMPLETED ·Phase: PHASE2