Trial Outcomes & Findings for Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis (NCT NCT04521114)
NCT ID: NCT04521114
Last Updated: 2023-03-01
Results Overview
Change in hepatic fat fraction from baseline assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) at week 14
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Change from baseline (day one, first day of treatment) to EOT (day 92, 13 weeks of treatment)
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Leronlimab 700 mg
700 mg SC weekly injection
|
Leronlimab 350 mg
350 mg SC weekly injection
|
Placebo
Placebo SC weekly injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
27
|
30
|
|
Overall Study
COMPLETED
|
24
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
2
|
Reasons for withdrawal
| Measure |
Leronlimab 700 mg
700 mg SC weekly injection
|
Leronlimab 350 mg
350 mg SC weekly injection
|
Placebo
Placebo SC weekly injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Sponsor Wish
|
1
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
2
|
2
|
0
|
Baseline Characteristics
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Leronlimab 700 mg
n=30 Participants
700mg SC weekly injection
|
Leronlimab 350 mg
n=27 Participants
350mg SC weekly injection
|
Placebo
n=30 Participants
Placebo SC weekly injection
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Age
|
53.2 years
STANDARD_DEVIATION 13.68 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
53.80 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI
|
41.2 kg/m^2
STANDARD_DEVIATION 9.56 • n=5 Participants
|
38.0 kg/m^2
STANDARD_DEVIATION 5.52 • n=7 Participants
|
38.4 kg/m^2
STANDARD_DEVIATION 5.89 • n=5 Participants
|
39.2 kg/m^2
STANDARD_DEVIATION 7.33 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (day one, first day of treatment) to EOT (day 92, 13 weeks of treatment)Population: Full Analysis Set
Change in hepatic fat fraction from baseline assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) at week 14
Outcome measures
| Measure |
Leronlimab 700 mg
n=22 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=22 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
MRI-PDFF Change From Baseline to Week 14
|
-1.25 Percentage of hepatic fat fraction
Interval -2.6 to 2.3
|
-0.90 Percentage of hepatic fat fraction
Interval -3.1 to 0.4
|
0.90 Percentage of hepatic fat fraction
Interval -0.2 to 3.7
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Full Analysis Set
MRI corrected T1 (cT1) is emerging as a promising quantitative surrogate metric for assessing a composite of liver inflammation and fibrosis.
Outcome measures
| Measure |
Leronlimab 700 mg
n=22 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=22 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
MRI-cT1 Change From Baseline to Week 14
|
-7.0 Milliseconds (ms)
Interval -35.0 to 22.0
|
-2.00 Milliseconds (ms)
Interval -54.0 to 24.0
|
22.0 Milliseconds (ms)
Interval 2.0 to 41.0
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Alkaline Phosphatase
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Alkaline Phosphatase
|
0.37 IU/L
Standard Deviation 7.77
|
-3.68 IU/L
Standard Deviation 7.99
|
-0.83 IU/L
Standard Deviation 7.75
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at day 92Population: Safety Analysis Set
Change from Baseline to Week 14 in Alanine Aminotraferase (ALT)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Alanine Aminotraferase (ALT)
|
4.77 U/L
Standard Deviation 32.06
|
-0.76 U/L
Standard Deviation 16.65
|
1.79 U/L
Standard Deviation 18.83
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Aspartate Aminotransferase (AST)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Aspartate Aminotransferase (AST)
|
1.40 U/L
Standard Deviation 15.10
|
-6.12 U/L
Standard Deviation 33.33
|
2.17 U/L
Standard Deviation 13.23
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Gamma Glutamyl transferase, GGT S
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
GGT S
|
5.67 U/L
Standard Deviation 14.12
|
-3.00 U/L
Standard Deviation 14.73
|
0.90 U/L
Standard Deviation 11.61
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1, start of treatment) and at EOT (day 92)Population: Safety Analysis Set
Change in Neutrophils/Leukocytes ratio from Baseline to Week 14
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Neutrophils/Leukocytes
|
0.93 Ratio of neutrophils to leukocytes
Standard Deviation 5.94
|
-4.32 Ratio of neutrophils to leukocytes
Standard Deviation 8.42
|
0.55 Ratio of neutrophils to leukocytes
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Monocyte Chemotactic Protein 1 (CCL2)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
CCL2
|
57.60 pg/mL
Standard Deviation 175.98
|
-77.0 pg/mL
Standard Deviation 161.99
|
-38.57 pg/mL
Standard Deviation 140.75
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1, start of treatment) and at EOT (day 92)Population: Safety Analysis Population
Change from Baseline (day 1, start of treatment) to Week 14 (EOT) in Macrophage Inflammatory Protein 1 Alpha
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
CCL3
|
1.40 pg/mL
Standard Deviation 6.22
|
-7.20 pg/mL
Standard Deviation 5.03
|
-0.96 pg/mL
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in CCL-5 (Rantes)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
CCL5 (Rantes)
|
8.14 ng/mL
Standard Deviation 15.82
|
-6.80 ng/mL
Standard Deviation 44.40
|
-0.39 ng/mL
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1, start of treatment) and at EOT (day 92)Population: Safety Analysis Set
Change from baseline (day 1, start of treatment) to Week 14 (EOT) in Fibro Test Score measured on a scale of 0 to 1, where 0 to 0.27 is no fibrosis, 0.27 to 0.48 is minimal fibrosis, 0.48 to 0.58 is moderate fibrosis, 0.58 to 0.74 is advanced fibrosis and 0.74 to 1.00 is severe fibrosis (Cirrhosis). Minimum score is zero, maximum score (worst outcome) is 1.
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=29 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Fibro Test Score
|
0.02 score on a scale
Standard Deviation 0.06
|
0.01 score on a scale
Standard Deviation 0.07
|
-0.00 score on a scale
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1, start of treatment) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Eosinophils Chemotactic Protein
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
CCL11( Eotaxin-1)
|
29.30 pg/mL
Standard Deviation 87.67
|
-3.88 pg/mL
Standard Deviation 95.10
|
-41.32 pg/mL
Standard Deviation 116.25
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Population
Change from Baseline to week 14 in CCL18 (Pulmonary \& Activation-Reg Chemokine)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
CCL18
|
6.77 ng/mL
Standard Deviation 36.16
|
-27.28 ng/mL
Standard Deviation 40.49
|
-2.14 ng/mL
Standard Deviation 34.43
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Vascular Cell Adhesion Molecule 1
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
VCAM
|
35.93 ng/mL
Standard Deviation 178.64
|
-82.80 ng/mL
Standard Deviation 79.95
|
8.89 ng/mL
Standard Deviation 109.96
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Interleukin-1 Beta
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
Interleukin-1 Beta
|
0.06 pg/mL
Standard Deviation 0.31
|
0.09 pg/mL
Standard Deviation 0.46
|
0.16 pg/mL
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Interleukin 1 Receptor Antagonist
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
IL-1RA
|
6.37 pg/mL
Standard Deviation 125.39
|
-16.24 pg/mL
Standard Deviation 74.40
|
15.93 pg/mL
Standard Deviation 54.63
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Interleukin 6
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
IL-6
|
0.17 pg/mL
Standard Deviation 1.18
|
-0.24 pg/mL
Standard Deviation 0.68
|
0.31 pg/mL
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline to Week 14 in Interleukin 8
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
IL-8
|
-3.25 pg/mL
Standard Deviation 8.89
|
-2.18 pg/mL
Standard Deviation 7.81
|
-0.54 pg/mL
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1, start of treatment) and at EOT (day 92)Population: Safety Analysis Set
Change from baseline (day 1, start of treatment) to Week 14 (EOT) in Tumor Necrosis Factor Receptor 2
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
TNF Receptor 2
|
1.04 pg/mL
Standard Deviation 3.25
|
-1.66 pg/mL
Standard Deviation 2.24
|
0.79 pg/mL
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from Baseline (day 1, start of treatment) to Week 14 (EOT) in Tissue Inhibitor of Metalloproteinases 1 (ng/mL)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
TIMP-1
|
8.30 ng/mL
Standard Deviation 32.39
|
-11.76 ng/mL
Standard Deviation 29.33
|
1.25 ng/mL
Standard Deviation 25.62
|
SECONDARY outcome
Timeframe: Measured at baseline (day 1) and at EOT (day 92)Population: Safety Analysis Set
Change from baseline (start of treatment, day 1) to Week 14 (EOT) in En Rage (Receptor Advanced Glycation End-Products)
Outcome measures
| Measure |
Leronlimab 700 mg
n=30 Participants
Leronlimab 700 mg SC weekly injection
|
Leronlimab 350 mg
n=25 Participants
Leronlimab 350mg SC weekly injection
|
Placebo
n=28 Participants
Placebo SC weekly injection
|
|---|---|---|---|
|
En Rage
|
30.77 ng/mL
Standard Deviation 229.87
|
-60.40 ng/mL
Standard Deviation 245.32
|
54.96 ng/mL
Standard Deviation 141.75
|
Adverse Events
Leronlimab 700 mg
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Leronlimab 350 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leronlimab 700 mg
n=30 participants at risk
Leronlimab 700mg (Randomized)
|
Leronlimab 350 mg
n=27 participants at risk
Leronlimab 350 mg (Non-Randomized)
|
Placebo
n=30 participants at risk
Placebo (Randomized)
|
|---|---|---|---|
|
Gastrointestinal disorders
TOOTH ABSCESS
|
0.00%
0/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
3.3%
1/30 • Number of events 1 • 14 Weeks
|
|
Infections and infestations
EYE INFECTION BACTERIAL
|
3.3%
1/30 • Number of events 1 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
3.3%
1/30 • Number of events 1 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
3.3%
1/30 • Number of events 1 • 14 Weeks
|
|
Injury, poisoning and procedural complications
ACCIDENT
|
0.00%
0/30 • 14 Weeks
|
3.7%
1/27 • Number of events 1 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
Other adverse events
| Measure |
Leronlimab 700 mg
n=30 participants at risk
Leronlimab 700mg (Randomized)
|
Leronlimab 350 mg
n=27 participants at risk
Leronlimab 350 mg (Non-Randomized)
|
Placebo
n=30 participants at risk
Placebo (Randomized)
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30 • 14 Weeks
|
7.4%
2/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Investigations
C-reactive protein increased
|
23.3%
7/30 • 14 Weeks
|
29.6%
8/27 • 14 Weeks
|
10.0%
3/30 • 14 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
5/30 • 14 Weeks
|
7.4%
2/27 • 14 Weeks
|
13.3%
4/30 • 14 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
5/30 • 14 Weeks
|
7.4%
2/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
16.7%
5/30 • 14 Weeks
|
11.1%
3/27 • 14 Weeks
|
10.0%
3/30 • 14 Weeks
|
|
General disorders
Injection site erythema
|
6.7%
2/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/30 • 14 Weeks
|
7.4%
2/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Injury, poisoning and procedural complications
Injection site pain
|
10.0%
3/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Injury, poisoning and procedural complications
Rotator cuff syndrome
|
6.7%
2/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
|
Endocrine disorders
Hyperglycaemia
|
13.3%
4/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
3.3%
1/30 • 14 Weeks
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • 14 Weeks
|
7.4%
2/27 • 14 Weeks
|
3.3%
1/30 • 14 Weeks
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • 14 Weeks
|
11.1%
3/27 • 14 Weeks
|
3.3%
1/30 • 14 Weeks
|
|
Gastrointestinal disorders
Injection site pruritus
|
6.7%
2/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
6.7%
2/30 • 14 Weeks
|
|
Infections and infestations
COVID-19
|
6.7%
2/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
0.00%
0/30 • 14 Weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
3.3%
1/30 • 14 Weeks
|
3.7%
1/27 • 14 Weeks
|
10.0%
3/30 • 14 Weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
3/30 • 14 Weeks
|
0.00%
0/27 • 14 Weeks
|
3.3%
1/30 • 14 Weeks
|
Additional Information
Joseph Meidling, Senior Director - Clinical Operations
CytoDyn Inc.
Phone: (360) 980-8524
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place