Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
- Conditions
- Cutaneous Lupus Erythematosus
- Interventions
- Registration Number
- NCT03134222
- Lead Sponsor
- Gilead Sciences
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47
-
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
Key
- Use of prohibited concomitant medications per study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib 200 mg Lanraplenib placebo Filgotinib + lanraplenib placebo for 48 weeks Placebo to Filgotinib 200 mg Lanraplenib placebo After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48. Placebo Filgotinib placebo Filgotinib placebo + lanraplenib placebo for 12 weeks Placebo to Lanraplenib 30 mg Filgotinib placebo 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 Filgotinib placebo Lanraplenib + filgotinib placebo for 48 weeks Lanraplenib 30 mg Lanraplenib Lanraplenib + filgotinib placebo for 48 weeks Placebo to Filgotinib 200 mg Filgotinib After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48. Placebo Lanraplenib placebo Filgotinib placebo + lanraplenib placebo for 12 weeks Filgotinib 200 mg Filgotinib Filgotinib + lanraplenib placebo for 48 weeks Placebo to Lanraplenib 30 mg Lanraplenib After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.
- Primary Outcome Measures
Name Time Method Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12 Baseline; 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline Baseline; 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. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline Baseline; 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.
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline Baseline; Week 24 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. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline Baseline; Week 24 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.
Trial Locations
- Locations (16)
K.Papp Clinical Research
🇨🇦Waterloo, Canada
Dermatology Ottawa Research Centre
🇨🇦Ottawa, Canada
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Omega Research Consultants LLC
🇺🇸DeBary, Florida, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Inland Rheumatology Clinical Trials
🇺🇸Upland, California, United States
Wallace Rheumatic Studies Center
🇺🇸Beverly Hills, California, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Medderm Associates
🇺🇸San Diego, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
University Health Network (UHN) - Toronto Western Hospital
🇨🇦Toronto, Canada
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States