NCT03134222 - Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE) | Crick

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

47

Conditions

Cutaneous Lupus Erythematosus

Interventions

LanraplenibDRUG

30 mg tablets administered orally once daily with or without food

FilgotinibDRUG

200 mg tablets administered orally once daily with or without food

Lanraplenib placeboDRUG

Tablets administered orally once daily with or without food

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (16)

Wallace Rheumatic Studies Center

Beverly Hills, California, United States

St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare

Fullerton, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline; Week 12

Secondary Outcomes

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.

Time frame: Baseline; Week 12

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.

Time frame: Baseline; Week 12

Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline