Safety and Efficacy of Filgotinib and GS-9876 in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/27/2019
Start Date:May 24, 2017
End Date:December 2019

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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 GS-9876 in
females with moderately-to-severely active cutaneous lupus erythematosus (CLE).


Key Inclusion Criteria:

- Must have a diagnosis of CLE, either chronic (eg, discoid) or subacute CLE per
investigator evaluation, with the following:

- Moderately-to-severely active CLE (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.
We found this trial at
14
sites
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Phone: 727-466-0078
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Clearwater, FL
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8750 Wilshire Boulevard
Beverly Hills, California 90211
Phone: 310-360-9197
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Beverly Hills, CA
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Charlotte, North Carolina 28210
Phone: 704-247-9179
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Charlotte, NC
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Dallas, Texas 75231
Phone: 214-879-6737
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Dallas, TX
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Debary, Florida
Phone: 386-668-4202
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Debary, FL
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Hershey, Pennsylvania 17033
Phone: 717-531-1513
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Hershey, PA
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Los Angeles, California 90045
Phone: 310-337-7171
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Ottawa,
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Palm Desert, California 92260
Phone: 760-341-9777
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Palm Desert, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-615-2940
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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San Diego, California 92103
Phone: 619-542-0013
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San Diego, CA
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Upland, California 91786
Phone: 909-296-8700
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Upland, CA
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Phone: 336-716-3775
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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