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

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ClinicalTrials.gov Identifier: NCT03134222
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : April 8, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE April 25, 2017
First Posted Date  ICMJE April 28, 2017
Results First Submitted Date  ICMJE March 9, 2020
Results First Posted Date  ICMJE April 8, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Lupus Erythematosus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Lanraplenib 30 mg
    Lanraplenib + filgotinib placebo for 48 weeks
    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib placebo
  • Experimental: Filgotinib 200 mg
    Filgotinib + lanraplenib placebo for 48 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Lanraplenib placebo
  • Placebo Comparator: Placebo
    Filgotinib placebo + lanraplenib placebo for 12 weeks
    Interventions:
    • Drug: Lanraplenib placebo
    • Drug: Filgotinib placebo
  • 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.
    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib placebo
  • 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.
    Interventions:
    • Drug: Filgotinib
    • Drug: Lanraplenib placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2017)
50
Actual Study Completion Date  ICMJE December 18, 2019
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03134222
Other Study ID Numbers  ICMJE GS-US-436-4092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP