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

Cutaneous Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134222
• Other study ID #: GS-US-436-4092
• Status: Completed
• Phase: Phase 2
• Start date: May 24, 2017
• Est. completion date: December 18, 2019

Study information

• Verified date: June 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 18, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Lanraplenib
30 mg tablets administered orally once daily with or without food
• Filgotinib
200 mg tablets administered orally once daily with or without food
• Lanraplenib placebo
Tablets administered orally once daily with or without food
• Filgotinib placebo
Tablets administered orally once daily with or without food

Locations

Country	Name	City	State
Canada	Dermatology Ottawa Research Centre	Ottawa
Canada	University Health Network (UHN) - Toronto Western Hospital	Toronto
Canada	K.Papp Clinical Research	Waterloo
United States	Wallace Rheumatic Studies Center	Beverly Hills	California
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Omega Research Consultants LLC	DeBary	Florida
United States	St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare	Fullerton	California
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Dermatology Research Associates	Los Angeles	California
United States	Desert Medical Advances	Palm Desert	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Medderm Associates	San Diego	California
United States	Inland Rheumatology Clinical Trials	Upland	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	Galapagos NV

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to 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.	Baseline; Week 12
Secondary	Percentage of Participants at Week 12 With Decrease of = 5 Points in CLASI Activity Score From Baseline	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.	Baseline; Week 12
Secondary	Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	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.	Baseline; Week 12
Secondary	Percentage of Participants at Week 24 With Decrease of = 5 Points in CLASI Activity Score From Baseline	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.	Baseline; Week 24
Secondary	Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline	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.	Baseline; Week 24