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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | 200 mg tablet administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 16 |
| Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Prior treatments as follows:
Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Monitor | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35294 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33380521 | Derived | 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. |
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22 participants were screened.
Participants were enrolled at study sites in United States. The first participant was screened on 06 October 2017. The last study visit occurred on 03 February 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanraplenib 30 mg | Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks. After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Phase (Up to Week 16) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2018 | Apr 2, 2020 |
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| 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. |
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| Lanraplenib | Drug | 30 mg tablet administered orally once daily |
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| Filgotinib placebo | Drug | Tablet administered orally once daily |
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| Lanraplenib placebo | Drug | Tablet administered orally once daily |
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| 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. | 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]). | 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. | Week 16 |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of Florida | Gainesville | Florida | 32610-0272 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States |
| Georgia Nephrology Research Institute | Lawrenceville | Georgia | 30046 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of North Carolina at Chapel Hill / UNC School of Medicine | Chapel Hill | North Carolina | 27599-7155 | United States |
| FG001 | Filgotinib 200 mg | Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks. After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase. |
| FG002 | Lanraplenib 30 mg to Filgotinib 200 mg | At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks. At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. |
| FG003 | Filgotinib 200 mg to Lanraplenib 30 mg | At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks. At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. |
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| NOT COMPLETED |
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| Blinded Phase (Week 16 to 32) |
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| Extended Blinded Phase (Week 32 to 52) |
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The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanraplenib 30 mg | Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. |
| BG001 | Filgotinib 200 mg | Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| 24-Hour Urine Protein | Mean | Standard Deviation | g/day |
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| Estimated Glomerular Filtration Rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Urine Protein Creatinine Ratio (UPCR) | Mean | Standard Deviation | mg/mg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants in the Full Analysis Set (included all randomized participants who took at least 1 dose of study drug) with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 16 |
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| Secondary | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | g/day | Baseline; Week 16 |
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| Secondary | Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline; Week 16 |
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| Secondary | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | mg/mg | Baseline; Week 16 |
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| Secondary | 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]). | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Week 16 |
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First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Up to Week 16: Lanraplenib 30 mg | Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Up to Week 16: Filgotinib 200 mg | Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG002 | After Week 16: Lanraplenib 30 mg | At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily) for additional 16 weeks. After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | After Week 16: Filgotinib 200 mg | At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily) for additional 16 weeks. After 32 weeks of blinded treatment, participants who had ≥ 35% reduction in urinary protein excretion from baseline continued their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg | At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received filgotinib 200 mg + lanraplenib placebo for additional 16 weeks. At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG005 | After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg | At Week 16, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switched treatment and received lanraplenib 30 mg + filgotinib placebo for additional 16 weeks. At Week 32, participants who did not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 could continue whichever treatment that led to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
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| Amaurosis fugax | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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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.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2020 | Apr 2, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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