Phase 2
Completed N=9
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Lupus Membranous Nephropathy
Source: ClinicalTrials.gov NCT03285711 ↗
Enrolled (actual)
9
Serious AEs
7.1%
Results posted
May 2020
Primary outcomePrimary: Percent Change in Urine Protein From Baseline (Day 1) to Week 16 — -2.8; -51.2 percent change
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Urine Protein From Baseline (Day 1) to Week 16 |
-2.8; -51.2 | — |
| SECONDARY Change From Baseline (Day 1) in Urine Protein at Week 16 |
-0.177; -2.151 | — |
| SECONDARY Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 |
-59.4; -2.0 | — |
| SECONDARY Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 |
-4.407; -0.808 | — |
| SECONDARY Percentage of Participants With Partial Remission at Week 16 |
0; 50.0 | — |
| SECONDARY Percentage of Participants With Complete Remission at Week 16 |
0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of LMN (International Society of Nephrology [ISN] and the Renal Pathology Society [RPS] 2003 classification of lupus nephritis), either Class V alone, or Class V in combination with Class II.
- Urine protein excretion ≥ 1.5 grams per day
- Estimated glomerular filtration rate (eGFR) ≥ 40 mg/min/1.73m^2 based on the modification of diet in renal disease (MDRD) formulation at screening
- No evidence of active or latent tuberculosis (TB) as assessed during screening
Key Exclusion Criteria
- Prior treatments as follows:
- Previous treatment with a janus kinase (JAK) inhibitor within 3 months of Day 1
- Use of rituximab or other selective B lymphocyte depleting agents (including experimental agents) within 6 months of Day 1. Enrollment is permitted if the last dose was given > 6 months and CD19-positive B cells are detectable at Screening.
- Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03285711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.