Trial Outcomes & Findings for Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS (NCT NCT06524739)
NCT ID: NCT06524739
Last Updated: 2026-04-13
Results Overview
The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \[SBP; orthostatic hypotension\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
At Baseline and at Week 25
Results posted on
2026-04-13
Participant Flow
This study was conducted in the United States.
A total of 66 participants were screened, and 50 of these were screen failures. A total of 16 participants were randomized in the study.
Participant milestones
| Measure |
IgPro20/IgPro20
Participants received IgPro20 during Periods 1 and 2.
|
Placebo/IgPro20
Participants received a volume-matched placebo during Period 1, followed by IgPro20 in Period 2.
|
|---|---|---|
|
Double-blind Period (Period 1)
STARTED
|
11
|
5
|
|
Double-blind Period (Period 1)
COMPLETED
|
3
|
0
|
|
Double-blind Period (Period 1)
NOT COMPLETED
|
8
|
5
|
|
Open-label Period (Period 2)
STARTED
|
3
|
0
|
|
Open-label Period (Period 2)
COMPLETED
|
0
|
0
|
|
Open-label Period (Period 2)
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
IgPro20/IgPro20
Participants received IgPro20 during Periods 1 and 2.
|
Placebo/IgPro20
Participants received a volume-matched placebo during Period 1, followed by IgPro20 in Period 2.
|
|---|---|---|
|
Double-blind Period (Period 1)
Study Terminated by Sponsor
|
8
|
5
|
|
Open-label Period (Period 2)
Study Terminated by Sponsor
|
3
|
0
|
Baseline Characteristics
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
Baseline characteristics by cohort
| Measure |
IgPro20/IgPro20
n=11 Participants
Participants received IgPro20 during Periods 1 and 2.
|
Placebo/IgPro20
n=5 Participants
Participants received a volume-matched placebo during Period 1, followed by IgPro20 in Period 2.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
16 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Continuous
|
31.2 Years
STANDARD_DEVIATION 8.78 • n=193 Participants
|
37.8 Years
STANDARD_DEVIATION 8.47 • n=193 Participants
|
33.3 Years
STANDARD_DEVIATION 8.98 • n=386 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
5 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: At Baseline and at Week 25Population: Analysis was performed on the ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified time point. Due to early study termination, no participants in the placebo arm had available data at Week 25.
The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of \>=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure \[SBP; orthostatic hypotension\]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=11 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=5 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])
At Baseline
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
|
Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension])
At Week 25
|
33.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline and at Week 25Population: Analysis was performed on the ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25.
The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling "goofy," or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=3 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31)
|
-25.3 Score on a scale
Standard Deviation 10.07
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline and at Week 25Population: Analysis was performed on ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25.
The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of \>=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=3 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Change From Baseline in COMPASS-31 Total Score
|
-46.65 Score on a scale
Standard Deviation 6.014
|
—
|
—
|
SECONDARY outcome
Timeframe: At Baseline and at Week 25Population: Analysis was performed on ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25.
Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=2 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test
|
-13.25 Beats per minute
Standard Deviation 6.718
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any investigational product (IP).
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=11 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=5 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Any TEAE
|
10 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Any TEAE Related to Study Treatment
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Any Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE
Any Serious TEAE Related to Study Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP.
The participant data were rounded to one decimal place.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=11 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=5 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE
Any TEAE
|
90.9 Percentage of participants
|
80.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE
Any TEAE Related to Study Treatment
|
81.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE
Any Serious TEAE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE
Any Serious TEAE Related to Study Treatment
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=10 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=4 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=10 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=4 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Percentage of Participants With Clinically Significant ECG Abnormalities
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=10 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=4 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 45Population: Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure. Here, the 'N' included all participants who were evaluated for this outcome measure, and the 'n', included all participants who were evaluated for this outcome measure.
Outcome measures
| Measure |
IgPro20 (Double-blind Period)
n=10 Participants
Participants received IgPro20 during Double-blind treatment Period.
|
Placebo (Double-blind Period)
n=4 Participants
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 Participants
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
IgPro20 (Double-blind Period)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo (Double-blind Period)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IgPro20 (Open-label Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IgPro20 (Double-blind Period)
n=11 participants at risk
Participants received IgPro20 during Double-blind period.
|
Placebo (Double-blind Period)
n=5 participants at risk
Participants received a volume- matched placebo during Double-blind treatment Period.
|
IgPro20 (Open-label Period)
n=3 participants at risk
Participants received IgPro20 during Open-label period.
|
|---|---|---|---|
|
General disorders
Infusion site pain
|
27.3%
3/11 • Number of events 5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Pain
|
18.2%
2/11 • Number of events 2 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Catheter site pain
|
9.1%
1/11 • Number of events 2 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 4 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Infusion site swelling
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Injection site bruising
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
General disorders
Injection site pain
|
27.3%
3/11 • Number of events 3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 4 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
18.2%
2/11 • Number of events 2 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.1%
1/11 • Number of events 3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Investigations
Eosinophil count increased
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Investigations
Grip strength decreased
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Psychiatric disorders
Major depression
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
20.0%
1/5 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Renal and urinary disorders
Nephrolithiasis
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
|
Vascular disorders
Flushing
|
9.1%
1/11 • Number of events 1 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/5 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
0.00%
0/3 • Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place