Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

Browse trials for

• Kidney Diseases 3,839
• Glomerulonephritis, Membranous 113

Eligibility criteria

Study arms

• Experimental
  Lanraplenib 30 mg

  Participants receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment. After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.

  Drug: Lanraplenib · Drug: Filgotinib placebo

• Experimental
  Filgotinib 200 mg

  Participants receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment. After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.

  Drug: Filgotinib · Drug: Lanraplenib placebo

• Experimental
  Lanraplenib 30 mg to Filgotinib 200 mg

  At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive filgotinib 200 mg + lanraplenib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.

  Drug: Filgotinib · Drug: Lanraplenib placebo

• Experimental
  Filgotinib 200 mg to Lanraplenib 30 mg

  At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive lanraplenib 30 mg + filgotinib placebo for additional 16 weeks. At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.

  Drug: Lanraplenib · Drug: Filgotinib placebo

Interventions

• DrugFilgotinib

  200 mg tablet administered orally once daily

  Also known as: GS-6034, GLPG0634

• DrugLanraplenib

  30 mg tablet administered orally once daily

  Also known as: GS-9876

• DrugFilgotinib placebo

  Tablet administered orally once daily

• DrugLanraplenib placebo

  Tablet administered orally once daily

Primary outcomes

1. Percent Change in Urine Protein From Baseline (Day 1) to Week 16

   Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.

   Time frame: Baseline; Week 16

Secondary outcomes

1. Change From Baseline (Day 1) in Urine Protein at Week 16

   Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.

   Time frame: Baseline; Week 16

2. Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16

   Time frame: Baseline; Week 16

3. Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16

   UPCR was assessed by urine protein excretion during a 24-hour urine collection.

   Time frame: Baseline; Week 16

4. Percentage of Participants With Partial Remission at Week 16

   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 \[urine protein excretion \< 3 g/day\]).

   Time frame: Week 16

5. Percentage of Participants With Complete Remission at Week 16

   Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.

   Time frame: Week 16

Baseline characteristics

Publications

• Baker M, Chaichian Y, Genovese M, Derebail V, Rao P, Chatham W, Bubb M, Lim S, Hajian H, Gurtovaya O, Patel U, Tumlin J. Phase II, randomised, double-blind, multicentre study evaluating the safety and efficacy of filgotinib and lanraplenib in patients with lupus membranous nephropathy. RMD Open. 2020 Dec;6(3):e001490. doi: 10.1136/rmdopen-2020-001490. PubMed 33380521 ↗

Study documents

• Study protocol · Mar 21, 2018
• Statistical analysis plan · Jan 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No