A Randomized, Blinded, Placebo Controlled, Phase 2a Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants with Cutaneous Lupus Erythematosus (CLE)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501523-24-00

Acronym

GS-US-497-6486

Enrollment

Registered

2023-09-25

Start date

2023-10-12

Completion date

Unknown

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Lupus Erythematosus (CLE)

Brief summary

Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at Week 12.

Detailed description

Proportion of participants with Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) score of 0 or 1 at Week 12., Incidence of treatment-emergent adverse events (TEAEs)., Incidence of treatment-emergent serious adverse events (TESAEs)., Incidence of treatment-emergent laboratory abnormalities., PK characteristics of GS-5718

Interventions

DRUGGS-5718 film-coated tablets 15mg

DRUGPTM GS-5718

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at Week 12.	—

Secondary

Measure	Time frame
Proportion of participants with Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) score of 0 or 1 at Week 12., Incidence of treatment-emergent adverse events (TEAEs)., Incidence of treatment-emergent serious adverse events (TESAEs)., Incidence of treatment-emergent laboratory abnormalities., PK characteristics of GS-5718	—

Countries

Czechia, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026