Clinical trial NCT03134222: Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Lupus Erythematosus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2017-04-28
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
timeFrame: Baseline; Week 12
measure: Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
timeFrame: Baseline; Week 12
measure: Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
timeFrame: Baseline; Week 24
measure: Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
timeFrame: Baseline; Week 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Studies Center
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: San Diego
country: United States
facility: Medderm Associates
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants LLC
state: Florida
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
city: Toronto
country: Canada
facility: University Health Network (UHN) - Toronto Western Hospital
city: Waterloo
country: Canada
facility: K.Papp Clinical Research
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Werth VP, Fleischmann R, Robern M, Touma Z, Tiamiyu I, Gurtovaya O, Pechonkina A, Mozaffarian A, Downie B, Matzkies F, Wallace D. Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 30;61(6):2413-2423. doi: 10.1093/rheumatology/keab685.