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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Cutaneous Lupus Erythematosus

Treatments: Drug: Filgotinib; Drug: Lanraplenib placebo; Drug: Filgotinib placebo; Drug: Lanraplenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03134222

GS-US-436-4092

Details and patient eligibility

About

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).

Enrollment: 47 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 5 patient groups, including a placebo group

Lanraplenib 30 mg

Experimental group

Description:

Lanraplenib + filgotinib placebo for 48 weeks

Treatment:

Drug: Filgotinib placebo

Drug: Lanraplenib

Filgotinib 200 mg

Experimental group

Description:

Filgotinib + lanraplenib placebo for 48 weeks

Treatment:

Drug: Lanraplenib placebo

Drug: Filgotinib

Placebo

Placebo Comparator group

Description:

Filgotinib placebo + lanraplenib placebo for 12 weeks

Treatment:

Drug: Filgotinib placebo

Drug: Lanraplenib placebo

Placebo to Lanraplenib 30 mg

Experimental group

Description:

After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.

Treatment:

Drug: Filgotinib placebo

Drug: Lanraplenib

Placebo to Filgotinib 200 mg

Experimental group

Description:

After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.

Treatment:

Drug: Lanraplenib placebo

Drug: Filgotinib