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Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Phase 2 trial testing Filgotinib in Lupus Membranous Nephropathy in 9 participants. Completed in 3 February 2020.
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 6 October 2017 |
| Primary completion | 3 May 2019 |
| Estimated completion | 3 February 2020 |
| Sites | 7 locations across United States |
Gilead Sciences — full company profile →
Adults 18 to 75, any sex, with Lupus Membranous Nephropathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | -2.8 | |
| Filgotinib 200 mg | -51.2 | ± 25.67 |
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | -0.177 | |
| Filgotinib 200 mg | -2.151 | ± 2.2591 |
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | -59.4 | |
| Filgotinib 200 mg | -2.0 | ± 11.35 |
UPCR was assessed by urine protein excretion during a 24-hour urine collection.
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | -4.407 | |
| Filgotinib 200 mg | -0.808 | ± 0.7539 |
Partial Remission was defined as urine protein excretion below \< 3 g/day and urine protein excretion decrease by ≥ 50% among participants with baseline (Day 1) nephrotic range proteinuria \[urine protein excretion ≥ 3 g/day\]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria \[urine protein excretion \< 3 g/day\]).
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | 0 | |
| Filgotinib 200 mg | 50.0 |
Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
| Group | Value | 95% CI |
|---|---|---|
| Lanraplenib 30 mg | 0 | |
| Filgotinib 200 mg | 0 |
Time frame: First dose date up to the last dose date plus 30 days (maximum: 56 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Up to Week 16: Lanraplenib… | Up to Week 16: Filgotinib … | After Week 16: Lanraplenib… | After Week 16: Filgotinib … | After Week 16: Lanraplenib… | After Week 16: Filgotinib … |
|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — | — | — |
| Reaction | System | Up to Week 16: Lanraplenib… | Up to Week 16: Filgotinib … | After Week 16: Lanraplenib… | After Week 16: Filgotinib … | After Week 16: Lanraplenib… | After Week 16: Filgotinib … |
|---|---|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — | — | — |
| Amaurosis fugax | Eye disorders | — | — | — | — | — | — |
| Vitreous floaters | Eye disorders | — | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — | — |
| Food poisoning | Gastrointestinal disorders | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — | — | — |
| Pain | General disorders | — | — | — | — | — | — |
| Furuncle | Infections and infestations | — | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — | — |
| Pollakiuria | Renal and urinary disorders | — | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — | — |
Most-reported serious reactions: Systemic lupus erythematosus, Acute kidney injury.
Data from ClinicalTrials.gov NCT03285711 adverse events section.
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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