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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03134222
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: Filgotinib Drug: Lanraplenib Drug: Filgotinib placebo Drug: Lanraplenib placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : March 13, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib
Filgotinib 200 mg + lanraplenib placebo for 24 weeks
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: Lanraplenib placebo
Tablets administered orally once daily with or without food

Experimental: Lanraplenib
Lanraplenib 30 mg + filgotinib placebo for 24 weeks
Drug: Lanraplenib
30 mg tablets administered orally once daily with or without food
Other Name: GS-9876

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Placebo Comparator: Placebo
Placebo for 12 weeks, then participants will be re-randomized to receive filgotinib 200 mg + lanraplenib placebo or lanraplenib 30 mg + filgotinib placebo through Week 24.
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: Lanraplenib
30 mg tablets administered orally once daily with or without food
Other Name: GS-9876

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Drug: Lanraplenib placebo
Tablets administered orally once daily with or without food

Experimental: Extension Period
Participants who have not permanently discontinued study drug during the first 24 weeks may enter the subsequent 24-week extension period where they will continue to receive their assigned dose of study drug, in a blinded fashion.
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food

Drug: Lanraplenib
30 mg tablets administered orally once daily with or without food
Other Name: GS-9876

Drug: Filgotinib placebo
Tablets administered orally once daily with or without food

Drug: Lanraplenib placebo
Tablets administered orally once daily with or without food




Primary Outcome Measures :
  1. Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score from Baseline to Week 12 [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.


Secondary Outcome Measures :
  1. Proportion of Participants at Week 12 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.

  2. Proportion of Participants at Week 12 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 12 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.

  3. Proportion of Participants at Week 24 with Decrease of ≥ 5 Points in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease.

  4. Proportion of Participants at Week 24 with No Worsening in CLASI Activity Score from Baseline [ Time Frame: Baseline; Week 24 ]
    CLASI activity score measures disease activity, with higher scores indicating more severe disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134222


Locations
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United States, California
Wallace Rheumatic Studies Center
Beverly Hills, California, United States, 90211
St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Dermatology Research Associates
Los Angeles, California, United States, 90045
Desert Medical Advances
Palm Desert, California, United States, 92260
Medderm Associates
San Diego, California, United States, 92103
Inland Rheumatology Clinical Trials
Upland, California, United States, 91786
United States, Florida
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Omega Research Consultants LLC
DeBary, Florida, United States, 32713
United States, North Carolina
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28210
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Canada
Dermatology Ottawa Research Centre
Ottawa, Canada, K2C 3N2
University Health Network (UHN) - Toronto Western Hospital
Toronto, Canada, M5T 2S8
K.Papp Clinical Research
Waterloo, Canada, N2J 1C4
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03134222     History of Changes
Other Study ID Numbers: GS-US-436-4092
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases