Trial · NCT03285711
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
NCT03285711, Phase 2, Completed, Gilead Sciences; results first posted 2020-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN). Trials, record NCT03285711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03285711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
- NCT number
- NCT03285711
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Lupus Membranous Nephropathy
- Interventions
- Filgotinib, Lanraplenib, Filgotinib placebo, Lanraplenib placebo
- First posted
- 2017-09-18
- Last updated
- 2020-05-18
- Results first posted
- 2020-05-18
- Limitations and caveats
Gilead made a decision to discontinue enrollment after very low enrollment over 16 months. This decision was not due to any safety concerns. Only 9 participants were enrolled and 3 participants completed study, no inferential analyses were performed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Urine Protein From Baseline (Day 1) to Week 16 | Baseline; Week 16 | Urine protein was assessed by urinary protein excretion during a 24-hour urine collection. |
| Secondary | Change From Baseline (Day 1) in Urine Protein at Week 16 | Baseline; Week 16 | Urine protein was assessed by urinary protein excretion during a 24-hour urine collection. |
| Secondary | Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Baseline; Week 16 | |
| Secondary | Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 | Baseline; Week 16 | UPCR was assessed by urine protein excretion during a 24-hour urine collection. |
| Secondary | Percentage of Participants With Partial Remission at Week 16 | 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 \[urine protein excretion \< 3 g/day\]). |
| Secondary | Percentage of Participants With Complete Remission at Week 16 | Week 16 | Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Urine Protein From Baseline (Day 1) to Week 16 | Baseline; Week 16 | Participants in the Full Analysis Set (included all randomized participants who took at least 1 dose of study drug) with available data were analyzed. | percent change | MEAN |
| SECONDARY | Change From Baseline (Day 1) in Urine Protein at Week 16 | Baseline; Week 16 | Participants in the Full Analysis Set with available data were analyzed. | g/day | MEAN |
| SECONDARY | Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Baseline; Week 16 | Participants in the Full Analysis Set with available data were analyzed. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 | Baseline; Week 16 | Participants in the Full Analysis Set with available data were analyzed. | mg/mg | MEAN |
| SECONDARY | Percentage of Participants With Partial Remission at Week 16 | Week 16 | Participants in the Full Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Remission at Week 16 | Week 16 | Participants in the Full Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Urine Protein From Baseline (Day 1) to Week 16 | Lanraplenib 30 mg | -2.8 | percent change | ||
| Percent Change in Urine Protein From Baseline (Day 1) to Week 16 | Filgotinib 200 mg | -51.2 | Standard Deviation 25.67 | percent change | |
| Change From Baseline (Day 1) in Urine Protein at Week 16 | Lanraplenib 30 mg | -0.177 | g/day | ||
| Change From Baseline (Day 1) in Urine Protein at Week 16 | Filgotinib 200 mg | -2.151 | Standard Deviation 2.2591 | g/day | |
| Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Lanraplenib 30 mg | -59.4 | mL/min/1.73 m^2 | ||
| Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Filgotinib 200 mg | -2.0 | Standard Deviation 11.35 | mL/min/1.73 m^2 | |
| Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 | Lanraplenib 30 mg | -4.407 | mg/mg | ||
| Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 | Filgotinib 200 mg | -0.808 | Standard Deviation 0.7539 | mg/mg | |
| Percentage of Participants With Partial Remission at Week 16 | Lanraplenib 30 mg | 0 | percentage of participants | ||
| Percentage of Participants With Partial Remission at Week 16 | Filgotinib 200 mg | 50.0 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Phase (Up to Week 16) | STARTED | Lanraplenib 30 mg | 4 | |
| Blinded Phase (Up to Week 16) | STARTED | Filgotinib 200 mg | 5 | |
| Blinded Phase (Up to Week 16) | STARTED | Lanraplenib 30 mg to Filgotinib 200 mg | 0 | |
| Blinded Phase (Up to Week 16) | STARTED | Filgotinib 200 mg to Lanraplenib 30 mg | 0 | |
| Blinded Phase (Up to Week 16) | COMPLETED | Lanraplenib 30 mg | 1 | |
| Blinded Phase (Up to Week 16) | COMPLETED | Filgotinib 200 mg | 4 | |
| Blinded Phase (Up to Week 16) | COMPLETED | Lanraplenib 30 mg to Filgotinib 200 mg | 0 | |
| Blinded Phase (Up to Week 16) | COMPLETED | Filgotinib 200 mg to Lanraplenib 30 mg | 0 | |
| Blinded Phase (Up to Week 16) | NOT COMPLETED | Lanraplenib 30 mg | 3 | |
| Blinded Phase (Up to Week 16) | NOT COMPLETED | Filgotinib 200 mg | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Up to Week 16: Lanraplenib 30 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Up to Week 16: Filgotinib 200 mg | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | After Week 16: Lanraplenib 30 mg | 0 | 0 | |
| other | Anaemia | Blood and lymphatic system disorders | After Week 16: Filgotinib 200 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg | 1 | 1 | |
| other | Leukopenia | Blood and lymphatic system disorders | Up to Week 16: Lanraplenib 30 mg | 0 | 4 | |
| other | Leukopenia | Blood and lymphatic system disorders | Up to Week 16: Filgotinib 200 mg | 1 | 5 | |
| other | Leukopenia | Blood and lymphatic system disorders | After Week 16: Lanraplenib 30 mg | 0 | 0 | |
| other | Leukopenia | Blood and lymphatic system disorders | After Week 16: Filgotinib 200 mg | 0 | 3 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Up to Week 16: Lanraplenib 30 mg | 0 | 4 |
| Total, all-cause mortality | Up to Week 16: Filgotinib 200 mg | 0 | 5 |
| Total, all-cause mortality | After Week 16: Lanraplenib 30 mg | 0 | 0 |
| Total, all-cause mortality | After Week 16: Filgotinib 200 mg | 0 | 3 |
| Total, all-cause mortality | After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | 0 | 1 |
| Total, all-cause mortality | After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg | 0 | 1 |
| Total, other adverse events | Up to Week 16: Lanraplenib 30 mg | 4 | 4 |
| Total, other adverse events | Up to Week 16: Filgotinib 200 mg | 3 | 5 |
| Total, other adverse events | After Week 16: Lanraplenib 30 mg | 0 | 0 |
| Total, other adverse events | After Week 16: Filgotinib 200 mg | 1 | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33380521 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03285711
GET https://conductscience.org/api/trials/v1/NCT03285711/flow?page=2