- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134222
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
June 1, 2020 updated by: Gilead Sciences
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ottawa, Canada, K2C 3N2
- Dermatology Ottawa Research Centre
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Toronto, Canada, M5T 2S8
- University Health Network (UHN) - Toronto Western Hospital
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Waterloo, Canada, N2J 1C4
- K.Papp Clinical Research
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California
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Beverly Hills, California, United States, 90211
- Wallace Rheumatic Studies Center
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Fullerton, California, United States, 92835
- St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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Palm Desert, California, United States, 92260
- Desert Medical Advances
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San Diego, California, United States, 92103
- MedDerm Associates
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Upland, California, United States, 91786
- Inland Rheumatology Clinical Trials
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Florida
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Clearwater, Florida, United States, 33765
- Clinical Research of West Florida, Inc.
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DeBary, Florida, United States, 32713
- Omega Research Consultants LLC
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North Carolina
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Charlotte, North Carolina, United States, 28210
- DJL Clinical Research, PLLC
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Winston-Salem, North Carolina, United States, 27104
- Wake Forest University Health Sciences
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, United States, 75231
- Metroplex Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Key Inclusion Criteria:
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 Exclusion Criteria:
- Use of prohibited concomitant medications per study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lanraplenib 30 mg
Lanraplenib + filgotinib placebo for 48 weeks
|
30 mg tablets administered orally once daily with or without food
Other Names:
Tablets administered orally once daily with or without food
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Experimental: Filgotinib 200 mg
Filgotinib + lanraplenib placebo for 48 weeks
|
200 mg tablets administered orally once daily with or without food
Other Names:
Tablets administered orally once daily with or without food
|
Placebo Comparator: Placebo
Filgotinib placebo + lanraplenib placebo for 12 weeks
|
Tablets administered orally once daily with or without food
Tablets administered orally once daily with or without food
|
Experimental: 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.
|
30 mg tablets administered orally once daily with or without food
Other Names:
Tablets administered orally once daily with or without food
|
Experimental: 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.
|
200 mg tablets administered orally once daily with or without food
Other Names:
Tablets administered orally once daily with or without food
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
Time Frame: 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.
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Baseline; Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Time Frame: 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.
|
Baseline; Week 12
|
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
Time Frame: 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.
|
Baseline; Week 12
|
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Time Frame: 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.
|
Baseline; Week 24
|
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
Time Frame: 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.
|
Baseline; Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2017
Primary Completion (Actual)
March 13, 2019
Study Completion (Actual)
December 18, 2019
Study Registration Dates
First Submitted
April 25, 2017
First Submitted That Met QC Criteria
April 25, 2017
First Posted (Actual)
April 28, 2017
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-436-4092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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