Lupus Membranous NephropathyPhase 2NCT03285711

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

A Phase 2 study testing Filgotinib and Lanraplenib in people with Lupus Membranous Nephropathy, run by Gilead Sciences at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lupus Membranous Nephropathy
What is being tested?: Filgotinib and Lanraplenib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 7 sitesUnited States
Study dates: 6 Oct 2017to 3 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, 27599-7155
University of Florida
Gainesville, Florida, 32610-0272
Georgia Nephrology Research Institute
Lawrenceville, Georgia, 30046
Stanford University
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)

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).

Conditions: Lupus Membranous Nephropathy
Being tested: Filgotinib, Lanraplenib, Filgotinib placebo, Lanraplenib placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FilgotinibDrug
Also called GS-6034, GLPG0634
200 mg tablet administered orally once daily
LanraplenibDrug
Also called GS-9876
30 mg tablet administered orally once daily
Filgotinib placeboDrug
Tablet administered orally once daily
Lanraplenib placeboDrug
Tablet administered orally once daily

Study groups in NCT03285711
Study group	Role	What they receive
Lanraplenib 30 mg	Experimental	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. Receives: Drug: Lanraplenib; Drug: Filgotinib placebo
Filgotinib 200 mg	Experimental	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. Receives: Drug: Filgotinib; Drug: Lanraplenib placebo
Lanraplenib 30 mg to Filgotinib 200 mg	Experimental	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. Receives: Drug: Filgotinib; Drug: Lanraplenib placebo
Filgotinib 200 mg to Lanraplenib 30 mg	Experimental	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. Receives: Drug: Lanraplenib; Drug: Filgotinib placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline; Week 16

Secondary outcomes (5)

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.
Measured: Baseline; Week 16
Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
Measured: Baseline; Week 16
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.
Measured: Baseline; Week 16
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]).
Measured: Week 16
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.
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 20173 Feb 2020

First posted18 Sep 2017
Study start6 Oct 2017
Primary completion3 May 2019
Study completion3 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lupus Membranous NephropathyStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03285711
Sponsor's protocol ID: GS-US-437-4093
Status last verified: May 2020
First submitted: 14 Sep 2017
Last updated: 18 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lupus Membranous Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)
ClinicalTrials.gov ID: NCT03285711
Acronym / sponsor ID: GS-US-437-4093
Conditions: Lupus Membranous Nephropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 6 Oct 2017 (actual)
Primary completion: 3 May 2019 (actual)
Study completion: 3 Feb 2020 (actual)
First posted: 18 Sep 2017 (actual)
Results: Posted 18 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Lanraplenib 30 mg	Experimental	Drug: Lanraplenib, Drug: Filgotinib placeboParticipants 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.
Filgotinib 200 mg	Experimental	Drug: Filgotinib, Drug: Lanraplenib placeboParticipants 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.
Lanraplenib 30 mg to Filgotinib 200 mg	Experimental	Drug: Filgotinib, Drug: Lanraplenib placeboAt 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.
Filgotinib 200 mg to Lanraplenib 30 mg	Experimental	Drug: Lanraplenib, Drug: Filgotinib placeboAt 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 (5 listed)

Prior treatments as follows:
Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FilgotinibAlso: GS-6034, GLPG0634200 mg tablet administered orally once daily	Drug	Filgotinib 200 mg, Lanraplenib 30 mg to Filgotinib 200 mg
LanraplenibAlso: GS-987630 mg tablet administered orally once daily	Drug	Filgotinib 200 mg to Lanraplenib 30 mg, Lanraplenib 30 mg
Filgotinib placeboTablet administered orally once daily	Drug	Filgotinib 200 mg to Lanraplenib 30 mg, Lanraplenib 30 mg
Lanraplenib placeboTablet administered orally once daily	Drug	Filgotinib 200 mg, Lanraplenib 30 mg to Filgotinib 200 mg

Primary outcome

Percent Change in Urine Protein From Baseline (Day 1) to Week 16
Time frame: Baseline; Week 16
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.

5 secondary outcomes

Change From Baseline (Day 1) in Urine Protein at Week 16
Time frame: Baseline; Week 16
Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
Time frame: Baseline; Week 16
Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16
Time frame: Baseline; Week 16
Percentage of Participants With Partial Remission at Week 16
Time frame: Week 16
Percentage of Participants With Complete Remission at Week 16
Time frame: Week 16

Results and safety

Results posted to the registry on 18 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanraplenib 30 mg	4	1
Filgotinib 200 mg	5	4
Lanraplenib 30 mg to Filgotinib 200 mg	0	0
Filgotinib 200 mg to Lanraplenib 30 mg	0	0

Primary outcome: Percent Change in Urine Protein From Baseline (Day 1) to Week 16

Time frame: Baseline; Week 16. Mean (Standard Deviation). Unit: percent change

Measure	Lanraplenib 30 mg n = 1	Filgotinib 200 mg n = 4
Value	-2.8	-51.2 (25.67)

Population analysed: Participants in the Full Analysis Set (included all randomized participants who took at least 1 dose of study drug) with available data were analyzed.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to the last dose date plus 30 days (maximum: 56 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Up to Week 16: Lanraplenib 30 mg	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Up to Week 16: Filgotinib 200 mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
After Week 16: Lanraplenib 30 mg	0 of 0	0 of 0	0
After Week 16: Filgotinib 200 mg	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33380521Baker 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.
Individual participant dataSharing planned: No

Related trials for Lupus Membranous Nephropathy

Not yet recruiting
MYTP01 for Immune-Mediated Diseases
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Monitor study director

Gilead Sciences

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgotinib and Lanraplenib in people with Lupus Membranous Nephropathy, run by Gilead Sciences at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Urine Protein From Baseline (Day 1) to Week 16 (time frame: Baseline; Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03285711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.