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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 : Completed
First Posted : April 28, 2017
Results First Posted : March 26, 2020
Last Update Posted : April 8, 2020
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: Lanraplenib Drug: Filgotinib Drug: Lanraplenib placebo Drug: Filgotinib placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Filgotinib
Filgotinib 200 mg + lanraplenib placebo for 24 weeks
Drug: Filgotinib
200 mg tablets administered orally once daily with or without food
Other Name: GS-6034

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

Placebo Comparator: Placebo
Lanraplenib placebo or filgotinib placebo for 12 weeks. Following the completion of Week 12 assessments, participants will be re-randomized 1:1 in a blinded fashion to receive lanraplenib 30 mg + filgotinib placebo or filgotinib 200 mg + lanraplenib placebo through Week 24.
Drug: Lanraplenib
30 mg tablets administered orally once daily with or without food
Other Name: GS-9876

Drug: Filgotinib
200 mg tablets administered orally once daily with or without food
Other Name: GS-6034

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

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

Drug: Filgotinib
200 mg tablets administered orally once daily with or without food
Other Name: GS-6034

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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 cutaneous lupus erythematosus (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
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] October 15, 2018
Statistical Analysis Plan  [PDF] May 13, 2019

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03134222    
Other Study ID Numbers: GS-US-436-4092
First Posted: April 28, 2017    Key Record Dates
Results First Posted: March 26, 2020
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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