Trial Outcomes & Findings for Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis (NCT NCT04340362)
NCT ID: NCT04340362
Last Updated: 2025-09-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
From Baseline up to Week 13
Results posted on
2025-09-24
Participant Flow
This study was planned in 2 parts: Part A (Treatment Period), which consisted of 2 cohorts (i.e., cohort 1 and 2) and Part B (Optional Exploratory Off-treatment Follow-up Period). The primary and secondary efficacy analyses and safety analyses were planned for only Part A.
This study was conducted on adult participants who had APOL1-mediated focal segmental glomerulosclerosis (FSGS).
Participant milestones
| Measure |
VX-147
All participants received VX-147 at a dosage of 15 mg once daily (qd) for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately greater than or equal to (≥) 3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Cohort 1
|
3
|
|
Overall Study
Cohort 2
|
13
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
VX-147
All participants received VX-147 at a dosage of 15 mg once daily (qd) for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately greater than or equal to (≥) 3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Overall Study
Withdrawal of consent (not due to adverse event)
|
1
|
Baseline Characteristics
The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
Baseline characteristics by cohort
| Measure |
VX-147
n=16 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Race (NIH/OMB)
Cohort 2 · White
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · American Indian or Alaska Native
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · Asian
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · Black or African American
|
13 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Age, Continuous
Cohort 1
|
45.0 years
STANDARD_DEVIATION 10.5 • n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Age, Continuous
Cohort 2
|
37.3 years
STANDARD_DEVIATION 15.2 • n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Sex: Female, Male
Cohort 1 · Female
|
2 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Sex: Female, Male
Cohort 1 · Male
|
1 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Sex: Female, Male
Cohort 2 · Female
|
7 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Sex: Female, Male
Cohort 2 · Male
|
6 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Hispanic or Latino
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Not Hispanic or Latino
|
3 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 1 · Unknown or Not Reported
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Hispanic or Latino
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Not Hispanic or Latino
|
13 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Ethnicity (NIH/OMB)
Cohort 2 · Unknown or Not Reported
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · American Indian or Alaska Native
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · Asian
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · Black or African American
|
3 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · White
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · More than one race
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 1 · Unknown or Not Reported
|
0 Participants
n=3 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · More than one race
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Race (NIH/OMB)
Cohort 2 · Unknown or Not Reported
|
0 Participants
n=13 Participants • The Baseline data were planned to be presented separately for Cohort 1 and Cohort 2. Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Urine Protein to Creatinine Ratio (UPCR)
Cohort 1
|
3.47 g/g
STANDARD_DEVIATION 1.07 • n=3 Participants • The baseline data were planned to be presented for the overall treatment arm (i.e. Cohort 1 and Cohort 2). Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
|
Urine Protein to Creatinine Ratio (UPCR)
Cohort 2
|
1.77 g/g
STANDARD_DEVIATION 0.49 • n=13 Participants • The baseline data were planned to be presented for the overall treatment arm (i.e. Cohort 1 and Cohort 2). Here, "Number Analyzed" signifies participants who were evaluable for specified Cohort of the study.
|
PRIMARY outcome
Timeframe: From Baseline up to Week 13Population: The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug in the treatment period. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome and the "Number Analyzed" signifies participants who were evaluable for the specified Cohorts.
Outcome measures
| Measure |
VX-147
n=13 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks and had ≥ 80% adherence to investigational product. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Percent Change From Baseline in UPCR
Cohort 1
|
-47.7 percent change
Interval -70.1 to -8.5
|
|
Percent Change From Baseline in UPCR
Cohort 2
|
-47.5 percent change
Interval -63.4 to -24.6
|
|
Percent Change From Baseline in UPCR
Total
|
-47.6 percent change
Interval -60.0 to -31.3
|
SECONDARY outcome
Timeframe: From Baseline up to Week 17Population: Safety set included all participants who received at least 1 dose of study drug in the treatment period. Here, the "Number Analyzed" signifies participants who were evaluable for the specified cohorts.
Outcome measures
| Measure |
VX-147
n=16 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks and had ≥ 80% adherence to investigational product. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Cohort 1: Participants With TEAEs
|
3 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Cohort 1: Participants With SAEs
|
0 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Cohort 2: Participants With TEAEs
|
12 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Cohort 2: Participants With SAEs
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 2, 4, and 12 hours post-dose on Day 1 and Week 5Population: The PK set included all those who received at least 1 dose of study drug. Though participants in this study were divided into two cohorts based on their UPCR range, PK data was collected and presented based on dose levels as all participants received 15 mg qd for 2 weeks and 45 mg qd for 11 weeks. Therefore, presenting data based on cohorts as per UPCR range was not relevant for purpose of PK endpoints. Here "Number Analyzed" signifies participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
VX-147
n=16 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks and had ≥ 80% adherence to investigational product. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
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|---|---|
|
Maximum Observed Concentration (Cmax) of VX-147
15 mg qd: Day 1
|
0.168 micrograms per milliliter (mcg/ml)
Standard Deviation 0.0630
|
|
Maximum Observed Concentration (Cmax) of VX-147
45 mg qd: Week 5
|
0.846 micrograms per milliliter (mcg/ml)
Standard Deviation 0.303
|
SECONDARY outcome
Timeframe: Pre-dose on Day 8, 15, Week 3, 5, 9 and 13Population: The PK set included all those who received at least 1 dose of study drug. Though participants in this study were divided into two cohorts based on their UPCR range, PK data was collected and presented based on dose levels as all participants received 15 mg qd for 2 weeks and 45 mg qd for 11 weeks. Therefore, presenting data based on cohorts as per UPCR range was not relevant for purpose of PK endpoints. Here "Number Analyzed" signifies participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
VX-147
n=16 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks and had ≥ 80% adherence to investigational product. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
15 mg qd: Day 8
|
0.153 mcg/ml
Standard Deviation 0.0984
|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
15 mg qd: Day 15
|
0.123 mcg/ml
Standard Deviation 0.0796
|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
45 mg qd: Week 3
|
0.379 mcg/ml
Standard Deviation 0.249
|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
45 mg qd: Week 5
|
0.492 mcg/ml
Standard Deviation 0.265
|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
45 mg qd: Week 9
|
0.446 mcg/ml
Standard Deviation 0.342
|
|
Observed Pre-dose Concentration (Ctrough) of VX-147
45 mg qd: Week 13
|
0.529 mcg/ml
Standard Deviation 0.302
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 2, 4, 12 and 24 hours Post-dose on Week 5Population: The PK set included all those who received at least 1 dose of study drug. Though participants in this study were divided into two cohorts based on their UPCR range, PK data was collected and presented based on dose levels as all participants received 15 mg qd for 2 weeks and 45 mg qd for 11 weeks. Therefore, presenting data based on cohorts as per UPCR range was not relevant for purpose of PK endpoints. Here "Number Analyzed" signifies participants who were evaluable at specified timepoint.
Outcome measures
| Measure |
VX-147
n=13 Participants
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks and had ≥ 80% adherence to investigational product. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|
|
Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-147
|
15.3 hour*mcg/mL (h*mcg/mL)
Standard Deviation 6.37
|
Adverse Events
VX-147 : Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VX-147: Cohort 2
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
VX-147 Total
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VX-147 : Cohort 1
n=3 participants at risk
Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%).
|
VX-147: Cohort 2
n=13 participants at risk
Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2
|
VX-147 Total
n=16 participants at risk
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
Other adverse events
| Measure |
VX-147 : Cohort 1
n=3 participants at risk
Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%).
|
VX-147: Cohort 2
n=13 participants at risk
Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2
|
VX-147 Total
n=16 participants at risk
All participants received VX-147 at a dosage of 15 mg qd for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately ≥3 g/g (± 10%) and \<10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
12.5%
2/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Day 1 up to Week 17
|
15.4%
2/13 • Day 1 up to Week 17
|
12.5%
2/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Day 1 up to Week 17
|
15.4%
2/13 • Day 1 up to Week 17
|
18.8%
3/16 • Day 1 up to Week 17
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
General disorders
Fatigue
|
0.00%
0/3 • Day 1 up to Week 17
|
15.4%
2/13 • Day 1 up to Week 17
|
12.5%
2/16 • Day 1 up to Week 17
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
Tinea pedis
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • Day 1 up to Week 17
|
15.4%
2/13 • Day 1 up to Week 17
|
12.5%
2/16 • Day 1 up to Week 17
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Investigations
Electrocardiogram ST segment depression
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Day 1 up to Week 17
|
23.1%
3/13 • Day 1 up to Week 17
|
18.8%
3/16 • Day 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Day 1 up to Week 17
|
15.4%
2/13 • Day 1 up to Week 17
|
12.5%
2/16 • Day 1 up to Week 17
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Day 1 up to Week 17
|
23.1%
3/13 • Day 1 up to Week 17
|
25.0%
4/16 • Day 1 up to Week 17
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
33.3%
1/3 • Day 1 up to Week 17
|
0.00%
0/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Day 1 up to Week 17
|
7.7%
1/13 • Day 1 up to Week 17
|
6.2%
1/16 • Day 1 up to Week 17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place