Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
NCT ID: NCT03134222
Last Updated: 2020-06-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2017-05-24
2019-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
NCT03285711
A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
NCT05879718
A Study Evaluating the Effects of GLPG3667 Administered as Oral Treatment in Adult Participants With Active Systemic Lupus Erythematosus
NCT05856448
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
NCT04809623
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
NCT01405196
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lanraplenib 30 mg
Lanraplenib + filgotinib placebo for 48 weeks
Lanraplenib
30 mg tablets administered orally once daily with or without food
Filgotinib placebo
Tablets administered orally once daily with or without food
Filgotinib 200 mg
Filgotinib + lanraplenib placebo for 48 weeks
Filgotinib
200 mg tablets administered orally once daily with or without food
Lanraplenib placebo
Tablets administered orally once daily with or without food
Placebo
Filgotinib placebo + lanraplenib placebo for 12 weeks
Lanraplenib placebo
Tablets administered orally once daily with or without food
Filgotinib placebo
Tablets administered orally once daily with or without food
Placebo to Lanraplenib 30 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
Lanraplenib
30 mg tablets administered orally once daily with or without food
Filgotinib placebo
Tablets administered orally once daily with or without food
Placebo to Filgotinib 200 mg
After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.
Filgotinib
200 mg tablets administered orally once daily with or without food
Lanraplenib placebo
Tablets administered orally once daily with or without food
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lanraplenib
30 mg tablets administered orally once daily with or without food
Filgotinib
200 mg tablets administered orally once daily with or without food
Lanraplenib placebo
Tablets administered orally once daily with or without food
Filgotinib placebo
Tablets administered orally once daily with or without food
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index \[CLASI\] activity score ≥ 10) at screening and Day 1
* Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
* Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1
Exclusion Criteria
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
Fullerton, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
Medderm Associates
San Diego, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Omega Research Consultants LLC
DeBary, Florida, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Dermatology Ottawa Research Centre
Ottawa, , Canada
University Health Network (UHN) - Toronto Western Hospital
Toronto, , Canada
K.Papp Clinical Research
Waterloo, , Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Werth VP, Fleischmann R, Robern M, Touma Z, Tiamiyu I, Gurtovaya O, Pechonkina A, Mozaffarian A, Downie B, Matzkies F, Wallace D. Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 30;61(6):2413-2423. doi: 10.1093/rheumatology/keab685.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GS-US-436-4092
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.