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The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.
This is a Phase 2a proof of concept study designed to evaluate the safety and efficacy of GSK933776 for the treatment of geographic atrophy secondary to age-related macular degeneration. This is a placebo-controlled parallel-group study that is double masked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK933776 3 mg/kg | Experimental | 3 mg/kg administration of GSK933776 via intravenous infusion |
|
| GSK933776 6 mg/kg | Experimental | 6 mg/kg administration of GSK933776 via intravenous infusion |
|
| Placebo | Placebo Comparator | Placebo via intravenous infusion |
|
| GSK933776 15 mg/kg | Experimental | 15 mg/kg administration of GSK933776 via intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK933776 | Drug | GSK933776 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit. | Baseline (BL), 6 months, 12 months and 18 months |
| Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs. | Up to 21 months |
| Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | Up to 21 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85014 | United States | ||
| GSK Investigational Site |
The total duration of participation was approximately 25 months following screening.
This study was a parallel-group randomized study consisted of a screening visit, where 240 participants entered the observation period (minimum of 4 months), a Baseline visit at the end of observation phase, where 191 were randomized, and was followed by the treatment period (18 months), and a follow-up visit (3 months) after last dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months. |
| FG001 | GSK933776 (3 mg/kg) | Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
|
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: <85 millimeter of mercury (mmHg) and high: >160 mmHg and DBP was defined as: low:<45 mmHg and high: >100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. |
| Up to 21 months |
| Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:< 40 beats per minute (bpm) and high: >100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. | Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit |
| Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | 12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit |
| Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed. | At any point from Baseline through follow-up visit. |
| Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported. | Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal |
| Baseline, 6 months, 12 months and 18 months |
| Change From Baseline in Area of Total hypoAF in Study Eye | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, 6 months, 12 months and 18 months |
| Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing >30, >=15, >=10, >=5 and <5 letters. | Month 12 and Month 18 |
| Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline and every month up to Month 18 |
| Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| Clearance (CL) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| GSK Investigational Site | Arcadia | California | 91007 | United States |
| GSK Investigational Site | Irvine | California | 92697 | United States |
| GSK Investigational Site | La Jolla | California | 92037 | United States |
| GSK Investigational Site | Los Angeles | California | 90033-4500 | United States |
| GSK Investigational Site | Palm Desert | California | 92260 | United States |
| GSK Investigational Site | San Francisco | California | 94143 | United States |
| GSK Investigational Site | Torrance | California | 90503 | United States |
| GSK Investigational Site | Golden | Colorado | 80401 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Stuart | Florida | 34994 | United States |
| GSK Investigational Site | Tampa | Florida | 33612 | United States |
| GSK Investigational Site | Augusta | Georgia | 30909 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46290 | United States |
| GSK Investigational Site | New Albany | Indiana | 47150 | United States |
| GSK Investigational Site | Leawood | Kansas | 66211 | United States |
| GSK Investigational Site | Prairie Village | Kansas | 66208 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40215 | United States |
| GSK Investigational Site | Paducah | Kentucky | 42001 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21204 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21287 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Northfield | New Jersey | 08225 | United States |
| GSK Investigational Site | Toms River | New Jersey | 08755 | United States |
| GSK Investigational Site | New York | New York | 10003 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | West Mifflin | Pennsylvania | 15122 | United States |
| GSK Investigational Site | Ladson | South Carolina | 29406 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Abilene | Texas | 79606 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Galveston | Texas | 77550 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | United States |
| GSK Investigational Site | Silverdale | Washington | 98383 | United States |
| GSK Investigational Site | Mississauga | Ontario | L4W 1W9 | Canada |
| FG002 | GSK933776 (6 mg/kg) | Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| FG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo via intravenous infusion |
| BG001 | GSK933776 3 mg/kg | 3 mg/kg administration of GSK933776 via intravenous infusion |
| BG002 | GSK933776 6 mg/kg | 6 mg/kg administration of GSK933776 via intravenous infusion |
| BG003 | GSK933776 15 mg/kg | 15 mg/kg administration of GSK933776 via intravenous infusion |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
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| Race/Ethnicity, Customized | Number | Participants |
|
| 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 | Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye | Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit. | Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol. | Posted | Mean | 90% Confidence Interval | square millimeter (m^2) | Baseline (BL), 6 months, 12 months and 18 months |
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| Primary | Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs. | ITT Population: all participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose. | Posted | Number | Participants | Up to 21 months |
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| Primary | Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period | ITT Population | Posted | Number | Participants | Up to 21 months |
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| Primary | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: <85 millimeter of mercury (mmHg) and high: >160 mmHg and DBP was defined as: low:<45 mmHg and high: >100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. | ITT Population | Posted | Number | Participants | Up to 21 months |
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| Primary | Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR) | Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:< 40 beats per minute (bpm) and high: >100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented. | ITT Population | Posted | Number | Participants | Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit |
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| Primary | Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI) | 12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | ITT Population | Posted | Number | Participants | Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit |
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| Primary | Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI) | The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed. | ITT Population | Posted | Number | Participants | At any point from Baseline through follow-up visit. |
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| Primary | Number of Participants With Abnormal Magnetic Resonance Imaging (MRI) | Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported. | ITT Population | Posted | Number | Participants | Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal |
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| Secondary | Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Efficacy Population | Posted | Mean | 90% Confidence Interval | mm^2 | Baseline, 6 months, 12 months and 18 months |
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| Secondary | Change From Baseline in Area of Total hypoAF in Study Eye | Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Efficacy Population | Posted | Mean | 90% Confidence Interval | mm^2 | Baseline, 6 months, 12 months and 18 months |
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| Secondary | Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing >30, >=15, >=10, >=5 and <5 letters. | ITT Population | Posted | Number | Participants | Month 12 and Month 18 |
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| Secondary | Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18 | Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | ITT Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and every month up to Month 18 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants | Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | Pharmacokinetic (PK) Parameter Population: all participants in the ITT Population with derived PK parameters | Posted | Geometric Mean | 95% Confidence Interval | microgram (mcg)*hours (h)/mL | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 | PK Parameter Population | Posted | Geometric Mean | 95% Confidence Interval | nanogram (ng)/mL | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clearance (CL) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | PK Parameter Population | Posted | Geometric Mean | 95% Confidence Interval | mL/h | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | PK Parameter Population | Posted | Geometric Mean | 95% Confidence Interval | Days | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling | Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476. | PK Parameter Population | Posted | Geometric Mean | 95% Confidence Interval | mL | Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22) | Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | PD Concentration Population: all participants in the ITT Population with at least one PD sample | Posted | Mean | Standard Deviation | picogram (PG)/ML | Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18 |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication up to approximately 21 months.
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months. | 9 | 46 | 31 | 46 | ||
| EG001 | GSK933776 (3 mg/kg) | Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months. | 11 | 46 | 37 | 46 | ||
| EG002 | GSK933776 (6 mg/kg) | Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. | 9 | 48 | 32 | 48 | ||
| EG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. | 12 | 51 | 37 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary ostial stenosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Subendocardial ischaemia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular asystole | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Orthostatic hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
|
| White |
|
| 6 months, n=34, 30, 35, 39 |
|
| 12 months, n=33, 29, 34, 40 |
|
| 18 months, n=34, 30, 32, 39 |
|
| Median Difference (Final Values) |
| 0.20 |
| 2-Sided |
| 90 |
| -0.31 |
| 0.71 |
12 months visit |
| Superiority or Other |
| Mean Difference (Final Values) | 0.17 | 2-Sided | 90 | -0.33 | 0.68 | 18 months visit | Superiority or Other |
| Mean Difference (Final Values) | -0.23 | 2-Sided | 90 | -0.71 | 0.26 | 6 months visit | Superiority or Other |
| Mean Difference (Final Values) | 0.23 | 2-Sided | 90 | -0.26 | 0.72 | 12 months visit | Superiority or Other |
| Mean Difference (Final Values) | 0.28 | 2-Sided | 90 | -0.21 | 0.77 | 18 months visit | Superiority or Other |
| Mean Difference (Final Values) | -0.18 | 2-Sided | 90 | -0.66 | 0.29 | 6 months visit | Superiority or Other |
| Median Difference (Final Values) | 0.28 | 2-Sided | 90 | -0.19 | 0.75 | 12 months visit | Superiority or Other |
| Median Difference (Final Values) | 0.39 | 2-Sided | 90 | -0.08 | 0.86 | 18 months visit | Superiority or Other |
| OG002 | GSK933776 (6 mg/kg) | Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| Participants |
|
|
Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| GSK933776 (6 mg/kg) |
Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| OG002 |
| GSK933776 (6 mg/kg) |
Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
|
| OG003 |
| GSK933776 (15 mg/kg) |
Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
|
Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
| OG003 | GSK933776 (15 mg/kg) | Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|
Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
|
|
|
|
|
|
|
|
| OG003 |
| GSK933776 (15 mg/kg) |
Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months. |
|
|