A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3667 in adult subjects with active systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Brief summary

- Proportion of subjects who achieved the SLE responder index (SRI)-4 response at Week 32.

Detailed description

- Proportion of subjects who achieved the SRI-4 response at Week 48., - Proportion of subjects who achieved the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32 and Week 48, - Proportion of subjects with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A score at Week 32 and Week 48 ., - Proportion of subjects who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and Week 48., - Change from baseline in the 28-joint count for tender, swollen, and tender + swollen (active) joints at Week 32 and Week 48., - Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuation., - Estimated GLPG3667 maximum plasma concentration, area under the plasma concentration-time curve, and trough plasma concentration at steady-state.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo consists only of excipients which are identical to those in the active GLPG3667 drug product

DRUGGLPG3667

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
- Proportion of subjects who achieved the SLE responder index (SRI)-4 response at Week 32.	—

Secondary

Measure	Time frame
- Proportion of subjects who achieved the SRI-4 response at Week 48., - Proportion of subjects who achieved the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32 and Week 48, - Proportion of subjects with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A score at Week 32 and Week 48 ., - Proportion of subjects who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and Week 48., - Change from baseline in the 28-joint count for tender, swollen, and tender + swollen (active) joints at Week 32 and Week 48., - Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuation., - Estimated GLPG3667 maximum plasma concentration, area under the plasma concentration-time curve, and trough plasma concentration at steady-state.	—

Measure

Time frame

- Proportion of subjects who achieved the SRI-4 response at Week 48., - Proportion of subjects who achieved the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32 and Week 48, - Proportion of subjects with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-A score at Week 32 and Week 48 ., - Proportion of subjects who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and Week 48., - Change from baseline in the 28-joint count for tender, swollen, and tender + swollen (active) joints at Week 32 and Week 48., - Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuation., - Estimated GLPG3667 maximum plasma concentration, area under the plasma concentration-time curve, and trough plasma concentration at steady-state.

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Countries

Bulgaria, France, Germany, Hungary, Poland, Spain

Outcome results

None listed