Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
1 other identifier
interventional
47
2 countries
16
Brief Summary
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2017
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2019
CompletedResults Posted
Study results publicly available
April 8, 2020
CompletedJune 9, 2020
June 1, 2020
1.8 years
April 25, 2017
March 9, 2020
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Baseline; Week 12
Secondary Outcomes (4)
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Baseline; Week 12
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
Baseline; Week 12
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Baseline; Week 24
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
Baseline; Week 24
Study Arms (5)
Lanraplenib 30 mg
EXPERIMENTALLanraplenib + filgotinib placebo for 48 weeks
Filgotinib 200 mg
EXPERIMENTALFilgotinib + lanraplenib placebo for 48 weeks
Placebo
PLACEBO COMPARATORFilgotinib placebo + lanraplenib placebo for 12 weeks
Placebo to Lanraplenib 30 mg
EXPERIMENTALAfter Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
Placebo to Filgotinib 200 mg
EXPERIMENTALAfter Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.
Interventions
30 mg tablets administered orally once daily with or without food
200 mg tablets administered orally once daily with or without food
Tablets administered orally once daily with or without food
Tablets administered orally once daily with or without food
Eligibility Criteria
You may qualify if:
- Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:
- 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
You may not qualify if:
- Use of prohibited concomitant medications per study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Galapagos NVcollaborator
Study Sites (16)
Wallace Rheumatic Studies Center
Beverly Hills, California, 90211, United States
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Medderm Associates
San Diego, California, 92103, United States
Inland Rheumatology Clinical Trials
Upland, California, 91786, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Omega Research Consultants LLC
DeBary, Florida, 32713, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Dermatology Ottawa Research Centre
Ottawa, K2C 3N2, Canada
University Health Network (UHN) - Toronto Western Hospital
Toronto, M5T 2S8, Canada
K.Papp Clinical Research
Waterloo, N2J 1C4, Canada
Related Publications (1)
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.
PMID: 34498056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2017
First Posted
April 28, 2017
Study Start
May 24, 2017
Primary Completion
March 13, 2019
Study Completion
December 18, 2019
Last Updated
June 9, 2020
Results First Posted
April 8, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share