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| ID | Type | Description | Link |
|---|---|---|---|
| CD24Fc-003 | Other Identifier | OncoImmune, Inc. | |
| HP-00086029 | Other Identifier | OncoImmune, Inc. | |
| MK-7110-003 | Other Identifier | Merck |
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Business Reasons
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
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This is a phase 2, randomized, double-blinded, placebo-controlled clinical trial. The intervention drug will be efprezimod alfa (intravenous [IV] infusion). A cohort of 64 patients with HIV on antiretroviral therapy (ART) will be randomized in a 1:1 fashion to be administered 3 doses of efprezimod alfa (240mg IV infusion) or placebo once every 2 weeks (q2w) during a 4-week window, followed by a 24-week follow-up window to assess the changes in LDL.
This study is a phase 2, randomized, placebo-control, double-blinded clinical trial to assess the effect of efprezimod alfa on reduction in low-density lipoprotein (LDL) among patients with HIV. The effect of efprezimod alfa on total cholesterol and triglycerides, markers of immune activation (T cell activation, sCD14, and inflammatory cytokines), size of HIV reservoirs, hemoglobin (HbA1c) and leptin, and hepatic steatosis will be evaluated.
It is hypothesized that therapy with efprezimod alfa will result in significant decreases in LDL in HIV patients. In addition, efprezimod alfa may reduce leptin and cholesterol, HbA1c, hepatic steatosis and fibrosis, and markers of inflammation in patients with chronic HIV who are virally suppressed on ART.
In this phase 2 study, a cohort of 64 HIV patients virally suppressed on ART will be randomized in a 1:1 fashion to receive an intravenous infusion of 240 mg of efprezimod alfa vs. placebo administered every 2 weeks during a 4-week treatment window, followed by a 24- week follow-up period. Patients will be followed for safety and adverse events as well as changes in lipid metabolism and inflammatory markers during a 24-week follow-up period. This investigation will take place at the University of Maryland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efprezimod alfa Treatment | Experimental | Participants received an intravenous infusion of 240 mg of efprezimod alfa on Days 0, 14, and 28. |
|
| Placebo | Placebo Comparator | Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein) | Drug | Efprezimod alfa will be given as IV infusion, 240 mg per infusion, on Days 0, 14, and 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | LDL-C was measured in participant serum. The percent change from baseline at Week 6 is presented. | Baseline and Week 6 |
| Number of Participants With ≥1 Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who experienced an AE is presented. | Up to approximately 28 weeks |
| Number of Participants Who Withdrew From Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who withdrew from study treatment due to an AE is presented. | Up to approximately 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Total cholesterol, HDL-C, and triglycerides were measured in participant serum. The percent change from baseline at Weeks 6 and 28 for these lipid panel results is presented. | Baseline, Week 6, and Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Aortic F-fluorodeoxyglucose (FDG) Uptake | Arterial FDG uptake is used to evaluate arterial inflammation. Arterial FDG uptake was to be measured by positron emission tomography-computed tomography (PET/CT) scan at Baseline and Week 24 in the aortic root and the same superior vena cava, then reported as the aortic uptake value divided by the superior vena cava uptake value, the target-to-background ratio (TBR). The change from baseline at Week 24 was to be presented. |
Inclusion Criteria:
Provides signed and dated informed consent form
Is willing to comply with all study procedures and availability for the duration of the study
Is at least 50 years of age or older at screening
Has LDL-C > 70 mg/dL.
Has a median American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) ACC/AHA ASCVD risk score ≥ 7.5%.
Is available for clinical follow-up through Week 28 after enrollment.
Has chronic HIV infection based on documentation from a primary care physician that the participant has HIV and is on antiretroviral therapy (ART).
Is on a stable regimen of ART.
Has at least 2 years of maintained HIV ribonucleic acid (RNA) < 50 copies/mL (or < lower limit of quantification [LLOQ] if the local laboratory assay's LLOQ is ≥50 copies/mL) prior to Screening and HIV RNA<50 at screening.
Has CD4 cell count ≥350 cells/mm^3 at Screening.
Is able to communicate effectively with the study investigator and other key personnel
Has a primary care doctor for their medical management
Is willing to donate blood for sample storage to be used for future research
Female study participants with childbearing potential (defined below) and male study participants with female partners of childbearing potential must be willing to practice either:
Complete abstinence from sexual intercourse with a member of the opposite sex OR
Uses at least one form of effective contraception, in addition to correct use of either a male or female condom throughout dosing and for a defined period following the last dose (30 days for women, 14 days for men) of study medication
Agrees to adhere to Lifestyle Considerations throughout study duration
Exclusion Criteria:
Has a current or prior history of any of the following:
Has abnormal hematological and biochemical parameters at screening, unless the test has been repeated and at least one subsequent result is within the acceptable range prior to study drug administration, including:
Has poorly controlled diabetes as indicated by a screening glycosylated hemoglobin (HbA1c) >10
Has need for the use of the following medications from 21 days prior to the start of study drugs through the end of treatment:
Has hyperlipidemia (defined as an LDL ≥190 mg/dL), that is not being treated with 2018 ACC/AHA Cholesterol Clinical Practice guidelines (statins, Ezetimibe, PCSK9 inhibitors)
Has a known history of cardiac arrhythmia or baseline ECG with arrhythmia including but not limited to atrial fibrillation (with or without rapid ventricular rate), supraventricular tachycardia or ventricular tachycardia.
Has any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Is a female who is breast-feeding or planning to become pregnant during the first 24 weeks after study drug administration.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Virology, University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29983395 | Background | Tian RR, Zhang MX, Zhang LT, Zhang P, Ma JP, Liu M, Devenport M, Zheng P, Zhang XL, Lian XD, Ye M, Zheng HY, Pang W, Zhang GH, Zhang LG, Liu Y, Zheng YT. CD24 and Fc fusion protein protects SIVmac239-infected Chinese rhesus macaque against progression to AIDS. Antiviral Res. 2018 Sep;157:9-17. doi: 10.1016/j.antiviral.2018.07.004. Epub 2018 Jul 3. | |
| 32382131 |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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8 participants were randomized at 1 study site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD24Fc 240 mg | Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28. |
| FG001 | Placebo | Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2020 |
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Randomized, double blinded, placebo controlled.
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| Saline Solution | Drug | Sterile saline solution (0.9% sodium chloride) will be given as placebo via IV infusion, 100 ml per infusion, on Days 0, 14, and 28. |
|
|
| Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage |
The percent change from baseline in the percentage of T Cells in whole blood that are CD4+ and CD8+ at Weeks 6 and 28 was to be presented. |
| Baseline, Week 6, and Week 28 |
| Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | The percent change from baseline in the percentage of PBMCs that were INF+ at Weeks 6 and 28 was to be presented. | Baseline, Week 6, and Week 28 |
| Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | The percent change from baseline in the percentage of PBMCs that were TNF+ at Weeks 6 and 28 was to be presented. | Baseline, Week 6, and Week 28 |
| Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | The percent change from baseline in sCD14 concentration in whole blood at Weeks 6 and 28 was to be presented. | Baseline, Week 6, and Week 28 |
| Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Blood was collected at baseline, Week 6, and Week 28 for the determination of the number of copies of HIV proviral DNA in PBMCs. The change from baseline at Weeks 6 and 28 was to be presented. | Baseline, Week 6, and Week 28 |
| Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Troponin I and troponin T blood concentrations were to be measured. The percent change from baseline at Week 28 was to be presented. | Baseline and Week 28 |
| Percent Change From Baseline in Controlled Attenuation Parameter (CAP) as Determined by Transient Elastography of the Liver | CAP is a measure related to hepatic steatosis. CAP was measured in decibels per meter (dB/m) at baseline and Week 28. The percent change is presented. | Baseline and Week 28 |
| Percent Change From Baseline in Liver Stiffness as Determined by Transient Elastography of the Liver | Liver stiffness is a measure related to hepatic fibrosis. Liver stiffness was measured in kilopascals (kPa) at baseline and Week 28. The percent change is presented. | Baseline and Week 28 |
| Percent Change From Baseline in Leptin | Leptin concentration was measured in participant serum. The percent change from baseline at Weeks 6 and 28 is presented. | Baseline, Week 6, and Week 28 |
| Percent Change From Baseline in Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage HbA1c is the ratio of glycated hemoglobin to total hemoglobin x 100. The percent change from baseline at Weeks 6 and 28 is presented. | Baseline, Week 6, and Week 28 |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of CD24Fc | AUC was defined as the area of plasma concentration versus time curve from time zero to Week 28. Assessment of AUC was to be based on CD24Fc concentration measured in plasma samples collected at each study visit starting with Week 0. | Predose and 2 hours postdose at the Week 0, 2, and 4 visits; Any time during the Week 6, 16, and 28 visits. |
| Number of Participants With New Anti-Drug Antibodies | Anti-CD24Fc antibodies were to be quantified in participant blood samples. The number of participants who demonstrated development of new anti-drug antibodies were to be presented. | Baseline, Week 6, and Week 28 |
| Change From Baseline in Interluekin-6 (IL-6) Levels Following CD24Fc Treatment | Levels of IL-6 were to be measured in participant blood samples collected at baseline and Week 28. The change from baseline in IL-6 levels were to be presented. | Baseline and Week 28 |
| Change From Baseline in Apolipoprotein B (apoB) Levels | Levels of apoB were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. | Baseline and Week 28 |
| Change From Baseline in Lipoprotein(a) (Lp[a]) Levels | Levels of Lp(a) were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. | Baseline and Week 28 |
| Change From Baseline in Urine Albumin:Creatinine Ratio | The ratio between levels of albumin and creatine was measured in participant urine at baseline and Week 28. The change from baseline in the ratio is presented. | Baseline and Week 28 |
| Baseline and Week 24 |
| Tian RR, Zhang MX, Liu M, Fang X, Li D, Zhang L, Zheng P, Zheng YT, Liu Y. CD24Fc protects against viral pneumonia in simian immunodeficiency virus-infected Chinese rhesus monkeys. Cell Mol Immunol. 2020 Aug;17(8):887-888. doi: 10.1038/s41423-020-0452-5. Epub 2020 May 7. No abstract available. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CD24Fc 240 mg | Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28. |
| BG001 | Placebo | Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28. |
| BG002 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Low-Density Lipoprotein-Cholesterol (LDL-C) | LDL-C was measured in participant serum. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Serum Total Cholesterol | Total cholesterol was measured in participant serum. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Serum High-Density Lipoprotein-Cholesterol (HDL-C) | HDL-C was measured in participant serum. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Serum Triglycerides | Triglycerides were measured in participant serum. | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Controlled Attenuation Parameter (CAP) | Controlled Attenuation Parameter (CAP) was measured using Transient Elastography of the Liver. | Mean | Standard Deviation | Decibels/meter (dB/m) |
| ||||||||||||||
| Liver Stiffness | Liver stiffness was measured using Transient Elastography of the liver. | Mean | Standard Deviation | Kilopascal (kPa) |
| ||||||||||||||
| Serum Leptin | Leptin was measured in participant serum. | Mean | Standard Deviation | µg/L |
| ||||||||||||||
| Percent Glycated Hemoglobin (HbA1c) | HbA1c was measured in participant blood. | Mean | Standard Deviation | Percentage of Hemoglobin |
|
| 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 From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | LDL-C was measured in participant serum. The percent change from baseline at Week 6 is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 6 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With ≥1 Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who experienced an AE is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Up to approximately 28 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Withdrew From Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who withdrew from study treatment due to an AE is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Count of Participants | Participants | Up to approximately 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Total cholesterol, HDL-C, and triglycerides were measured in participant serum. The percent change from baseline at Weeks 6 and 28 for these lipid panel results is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 6, and Week 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage | The percent change from baseline in the percentage of T Cells in whole blood that are CD4+ and CD8+ at Weeks 6 and 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | The percent change from baseline in the percentage of PBMCs that were INF+ at Weeks 6 and 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
|
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| Secondary | Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | The percent change from baseline in the percentage of PBMCs that were TNF+ at Weeks 6 and 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | The percent change from baseline in sCD14 concentration in whole blood at Weeks 6 and 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Blood was collected at baseline, Week 6, and Week 28 for the determination of the number of copies of HIV proviral DNA in PBMCs. The change from baseline at Weeks 6 and 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Data for this outcome measure could not be collected because the laboratory was unable to run the assay. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Troponin I and troponin T blood concentrations were to be measured. The percent change from baseline at Week 28 was to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. Results for baseline and/or Week 28 were not quantifiable for any participants, so the change from baseline analysis could not be performed and no participants were analyzed. | Posted | Baseline and Week 28 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Controlled Attenuation Parameter (CAP) as Determined by Transient Elastography of the Liver | CAP is a measure related to hepatic steatosis. CAP was measured in decibels per meter (dB/m) at baseline and Week 28. The percent change is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 28 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Liver Stiffness as Determined by Transient Elastography of the Liver | Liver stiffness is a measure related to hepatic fibrosis. Liver stiffness was measured in kilopascals (kPa) at baseline and Week 28. The percent change is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline and Week 28 |
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| Secondary | Percent Change From Baseline in Leptin | Leptin concentration was measured in participant serum. The percent change from baseline at Weeks 6 and 28 is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 6, and Week 28 |
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| Secondary | Percent Change From Baseline in Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage HbA1c is the ratio of glycated hemoglobin to total hemoglobin x 100. The percent change from baseline at Weeks 6 and 28 is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 6, and Week 28 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of CD24Fc | AUC was defined as the area of plasma concentration versus time curve from time zero to Week 28. Assessment of AUC was to be based on CD24Fc concentration measured in plasma samples collected at each study visit starting with Week 0. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. The estimated time to set up new validated assays exceeds the known stability of collected samples; therefore the samples will not be analyzed. Therefore, no participants were analyzed. | Posted | Predose and 2 hours postdose at the Week 0, 2, and 4 visits; Any time during the Week 6, 16, and 28 visits. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New Anti-Drug Antibodies | Anti-CD24Fc antibodies were to be quantified in participant blood samples. The number of participants who demonstrated development of new anti-drug antibodies were to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. The estimated time to set up new validated assays exceeds the known stability of collected samples; therefore the samples will not be analyzed. Therefore, no participants were analyzed. | Posted | Baseline, Week 6, and Week 28 |
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| Secondary | Change From Baseline in Interluekin-6 (IL-6) Levels Following CD24Fc Treatment | Levels of IL-6 were to be measured in participant blood samples collected at baseline and Week 28. The change from baseline in IL-6 levels were to be presented. | The intended analysis population was all randomized participants who received ≥1 dose of study drug. No samples were collected for Week 28, so the change from baseline analysis could not be performed and no participants were analyzed. | Posted | Baseline and Week 28 |
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| Secondary | Change From Baseline in Apolipoprotein B (apoB) Levels | Levels of apoB were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 28 |
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| Secondary | Change From Baseline in Lipoprotein(a) (Lp[a]) Levels | Levels of Lp(a) were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. | All randomized participants who received ≥1 dose of study drug. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 28 |
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| Secondary | Change From Baseline in Urine Albumin:Creatinine Ratio | The ratio between levels of albumin and creatine was measured in participant urine at baseline and Week 28. The change from baseline in the ratio is presented. | All randomized participants who received ≥1 dose of study drug and had data available for the specified time point. | Posted | Mean | Standard Deviation | Ratio (g Albumin/mol Creatinine) | Baseline and Week 28 |
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| Other Pre-specified | Change From Baseline in Aortic F-fluorodeoxyglucose (FDG) Uptake | Arterial FDG uptake is used to evaluate arterial inflammation. Arterial FDG uptake was to be measured by positron emission tomography-computed tomography (PET/CT) scan at Baseline and Week 24 in the aortic root and the same superior vena cava, then reported as the aortic uptake value divided by the superior vena cava uptake value, the target-to-background ratio (TBR). The change from baseline at Week 24 was to be presented. | The intended analysis population was the first 12 randomized participants who received ≥1 dose of study drug, had LDL levels greater than 125 mg/dL, and volunteered for this optional measurement. No participants volunteered for the PET/CT scans required for this outcome measure. Therefore, no participants were analyzed. | Posted | Baseline and Week 24 |
|
|
Adverse events were monitored for up to approximately 28 weeks. All-Cause Mortality was monitored for up to approximately 36 weeks.
All-Cause Mortality includes all randomized participants. Adverse Events include participants who received ≥1 dose of study treatment.
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 | CD24Fc 240 mg | Participants received an intravenous infusion of 240 mg of CD24Fc on Days 0, 14, and 28. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Placebo | Participants received an intravenous infusion of placebo (sterile saline solution) on Days 0, 14, and 28. | 0 | 4 | 0 | 4 | 4 | 4 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glomerular filtration rate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Coronavirus test positive | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
Any reports, papers, and/or presentations must be reviewed and approved by the sponsor prior to submitting for publication. All publications relating to the study will comply with the guidelines set forth by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals drawn up by the International Committee of Medical Journal Editors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| May 12, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
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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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