Systemic Lupus Erythematosus
Conditions
Brief summary
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
Detailed description
Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2024.
Interventions
BIOLOGICALDaxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Willing and able to understand and provide written informed consent. * Must have completed the treatment period in the RECAST SLE study. * Women of childbearing potential must have a negative urine pregnancy test on Day 1. * Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.
Exclusion criteria
* Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration. * Participation in another clinical study with an IP during the RECAST SLE study period. * Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety. * Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1. * Clinically significant active infection at Visit 1, in the opinion of the Investigator. * Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to approximately 56 weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study. |
| Number of Participants Who Experienced Serious Adverse Events (SAEs) | Up to approximately 56 weeks | An AE is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s). |
| Number of Participants Who Experienced AEs of Special Interest (AESI) | Up to approximately 56 weeks | An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Daxdilimab | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 | Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study. |
| Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56 | PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study. |
| Number of Participants Expressing Anti-drug Antibodies (ADA) | Up to approximately 56 weeks | ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive. |
Countries
Argentina, Greece, India, Mexico, Poland, Serbia, Spain, Taiwan, United States
Participant flow
Recruitment details
This was an open-label extension (OLE) of study VIB7734.P2.S1 (NCT04925934). Eligible participants were enrolled after the completion of the VIB7734.P2.S1 study. 155 participants were enrolled at 54 centers in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain and Taiwan from 01 June 2022 to 31 October 2023.
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Daxdilimab 200 mg Q12W Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 47 |
| Daxdilimab 200 mg Q4W in Parent Study Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 57 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study. | 51 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Trial terminated by Sponsor | 39 | 50 | 46 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo/Daxdilimab 200 mg Q12W | Daxdilimab 200 mg Q4W in Parent Study | Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Total |
|---|---|---|---|---|
| Age, Continuous | 41.3 Years STANDARD_DEVIATION 10.3 | 44.8 Years STANDARD_DEVIATION 12.8 | 45.9 Years STANDARD_DEVIATION 11.2 | 44.1 Years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 24 Participants | 16 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 33 Participants | 35 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 5 Participants | 8 Participants | 20 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 5 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 6 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 39 Participants | 35 Participants | 109 Participants |
| Sex: Female, Male Female | 44 Participants | 52 Participants | 46 Participants | 142 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 57 | 0 / 51 |
| other Total, other adverse events | 12 / 47 | 19 / 57 | 19 / 51 |
| serious Total, serious adverse events | 3 / 47 | 5 / 57 | 5 / 51 |
Outcome results
Primary
Number of Participants Who Experienced AEs of Special Interest (AESI)
An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).
Time frame: Up to approximately 56 weeks
Population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced AEs of Special Interest (AESI) | 1 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Who Experienced AEs of Special Interest (AESI) | 2 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced AEs of Special Interest (AESI) | 1 Participants |
Primary
Number of Participants Who Experienced Serious Adverse Events (SAEs)
An AE is considered serious if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).
Time frame: Up to approximately 56 weeks
Population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Serious Adverse Events (SAEs) | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Who Experienced Serious Adverse Events (SAEs) | 5 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Serious Adverse Events (SAEs) | 5 Participants |
Primary
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Time frame: Up to approximately 56 weeks
Population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 25 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 31 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | 31 Participants |
Secondary
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Time frame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. The overall number of participants analzyed represents the number of participants contributing data to any individual timepoint within the table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 0 | 70.59 Percentage change in pDCs count | Standard Deviation 225.39 |
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 12 | 1.33 Percentage change in pDCs count | Standard Deviation 142.08 |
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 24 | -14.39 Percentage change in pDCs count | Standard Deviation 164.63 |
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 36 | 13.64 Percentage change in pDCs count | Standard Deviation 255.67 |
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 48 | -49.47 Percentage change in pDCs count | Standard Deviation 34.54 |
| Placebo/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 56 | -75.22 Percentage change in pDCs count | Standard Deviation 14.11 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 56 | -43.13 Percentage change in pDCs count | Standard Deviation 49.49 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 0 | -58.37 Percentage change in pDCs count | Standard Deviation 36.19 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 36 | -41.36 Percentage change in pDCs count | Standard Deviation 41.29 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 48 | -58.65 Percentage change in pDCs count | Standard Deviation 43.33 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 12 | 13.57 Percentage change in pDCs count | Standard Deviation 158.14 |
| Daxdilimab 200 mg Q4W in Parent Study | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 24 | -24.98 Percentage change in pDCs count | Standard Deviation 79.85 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 12 | -21.25 Percentage change in pDCs count | Standard Deviation 66.97 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 24 | -19.86 Percentage change in pDCs count | Standard Deviation 77.23 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 56 | 4.15 Percentage change in pDCs count | Standard Deviation 96.43 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 36 | -51.11 Percentage change in pDCs count | Standard Deviation 35.28 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 0 | -30.40 Percentage change in pDCs count | Standard Deviation 50.67 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count | Week 48 | -4.44 Percentage change in pDCs count | Standard Deviation 74.93 |
Secondary
Number of Participants Expressing Anti-drug Antibodies (ADA)
ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.
Time frame: Up to approximately 56 weeks
Population: Any Daxdilimab Analysis Set: all participants who received at least 1 dose of daxdilimab in parent study or OLE study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Both Baseline and post-Baseline positive | 7 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Persistent positive | 4 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Transient positive | 9 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only Baseline positive | 0 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA not detected | 34 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only post-Baseline positive | 6 Participants |
| Placebo/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA Incidence | 7 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | Both Baseline and post-Baseline positive | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA Incidence | 6 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only Baseline positive | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | Persistent positive | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only post-Baseline positive | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | Transient positive | 3 Participants |
| Daxdilimab 200 mg Q4W in Parent Study | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA not detected | 48 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Transient positive | 3 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA not detected | 44 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | ADA Incidence | 4 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only Baseline positive | 0 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Only post-Baseline positive | 3 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Both Baseline and post-Baseline positive | 2 Participants |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Number of Participants Expressing Anti-drug Antibodies (ADA) | Persistent positive | 2 Participants |
Secondary
Serum Concentration of Daxdilimab
Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Time frame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
Population: PK Analysis Set: all participants who received any dose of daxdilimab in OLE study and had at least 1 measurable PK concentration post dose. Number analyzed represents the number of participants with available data at that time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 56 | 0.399 ug/mL | Standard Deviation 0.251 |
| Placebo/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 48 | 0.813 ug/mL | Standard Deviation 1.044 |
| Placebo/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 24 | 0.414 ug/mL | Standard Deviation 0.575 |
| Placebo/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 36 | 0.508 ug/mL | Standard Deviation 0.616 |
| Placebo/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 12 | 0.291 ug/mL | Standard Deviation 0.39 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 24 | 0.398 ug/mL | Standard Deviation 0.531 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 56 | 0.146 ug/mL | Standard Deviation 0.009 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 0 | 5.527 ug/mL | Standard Deviation 4.412 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 12 | 0.502 ug/mL | Standard Deviation 0.74 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 36 | 0.464 ug/mL | Standard Deviation 0.467 |
| Daxdilimab 200 mg Q4W in Parent Study | Serum Concentration of Daxdilimab | Week 48 | 0.380 ug/mL | Standard Deviation 0.395 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 48 | 0.815 ug/mL | Standard Deviation 0.759 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 36 | 1.002 ug/mL | Standard Deviation 1.404 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 12 | 0.400 ug/mL | Standard Deviation 0.52 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 0 | 0.458 ug/mL | Standard Deviation 0.614 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 24 | 0.437 ug/mL | Standard Deviation 0.437 |
| Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 56 | 0.997 ug/mL | Standard Deviation 0.898 |