Trial Outcomes & Findings for Study to Assess Efficacy and Safety of VIT-2763 (Vamifeport) in Subjects With Sickle Cell Disease (NCT NCT04817670)
NCT ID: NCT04817670
Last Updated: 2025-02-18
Results Overview
Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline and after 8 weeks of treatment
Results posted on
2025-02-18
Participant Flow
There were 22 sites initiated for this study in 5 countries (The United Kingdom, Lebanon, Greece, the United States, and France).
A total of 46 participants were screened in this study, of which 28 were screen failures. Out of these 28 participants, 9 were rescreened, and 7 were found eligible for the study. 25 participants were enrolled in the study.
Participant milestones
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
Participants received VIT-2763 60 milligrams (mg) (2 x 30 mg capsules), orally, twice daily (BID) for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, three times daily (TID) for 8 weeks.
|
Cohort 4: Placebo
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
1
|
|
Overall Study
Intent-to-treat (ITT) Population
|
6
|
6
|
6
|
6
|
0
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
Participants received VIT-2763 60 milligrams (mg) (2 x 30 mg capsules), orally, twice daily (BID) for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, three times daily (TID) for 8 weeks.
|
Cohort 4: Placebo
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study to Assess Efficacy and Safety of VIT-2763 (Vamifeport) in Subjects With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=6 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 7.41 • n=99 Participants
|
36.0 years
STANDARD_DEVIATION 11.87 • n=107 Participants
|
29.3 years
STANDARD_DEVIATION 9.48 • n=206 Participants
|
25.3 years
STANDARD_DEVIATION 7.17 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 9.40 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 8 weeks of treatmentPopulation: This analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified timepoint.
Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=5 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin)
Baseline
|
24.0 micromoles per liter (umol/L)
Standard Deviation 13.51
|
56.4 micromoles per liter (umol/L)
Standard Deviation 43.71
|
44.0 micromoles per liter (umol/L)
Standard Deviation 24.48
|
31.2 micromoles per liter (umol/L)
Standard Deviation 12.95
|
—
|
|
Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin)
Change at 8 weeks
|
-4.0 micromoles per liter (umol/L)
Standard Deviation 4.69
|
-5.8 micromoles per liter (umol/L)
Standard Deviation 11.35
|
-21.8 micromoles per liter (umol/L)
Standard Deviation 11.62
|
0.6 micromoles per liter (umol/L)
Standard Deviation 7.30
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 8 weeks of treatmentPopulation: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified category.
Mean change from baseline in haemolysis markers was measured by direct and total bilirubin.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=5 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin)
Direct Bilirubin
|
-0.5 umol/L
Standard Deviation 1.29
|
-2.0 umol/L
Standard Deviation 2.83
|
-2.5 umol/L
Standard Deviation 7.05
|
-0.4 umol/L
Standard Deviation 1.52
|
—
|
|
Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin)
Total Bilirubin
|
-4.2 umol/L
Standard Deviation 4.76
|
-13.2 umol/L
Standard Deviation 16.57
|
-26.0 umol/L
Standard Deviation 16.00
|
-0.2 umol/L
Standard Deviation 7.08
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 8 weeks of treatmentPopulation: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure.
Mean change from baseline in haemolysis markers was measured by lactate dehydrogenase.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=4 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=3 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=3 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=5 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase)
|
-45.8 units per liter (U/L)
Standard Deviation 47.56
|
-24.0 units per liter (U/L)
Standard Deviation 6.08
|
7.7 units per liter (U/L)
Standard Deviation 197.50
|
47.8 units per liter (U/L)
Standard Deviation 60.06
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 8 weeks of treatmentPopulation: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure.
Mean change from baseline in haemolysis markers was measured by potassium.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=5 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Haemolysis Marker (Potassium)
|
0.08 millimoles per liter (mmol/L)
Standard Deviation 0.396
|
0.08 millimoles per liter (mmol/L)
Standard Deviation 0.192
|
-0.22 millimoles per liter (mmol/L)
Standard Deviation 0.319
|
-0.05 millimoles per liter (mmol/L)
Standard Deviation 0.295
|
—
|
SECONDARY outcome
Timeframe: Baseline and after 8 weeks of treatmentPopulation: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified category.
Mean change from baseline in haemolysis markers was measured by hemoglobin and haptoglobin.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=5 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=5 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin)
Hemoglobin
|
-3.400 grams per liter (g/L)
Standard Deviation 1.4748
|
-2.067 grams per liter (g/L)
Standard Deviation 5.5142
|
-1.575 grams per liter (g/L)
Standard Deviation 8.4017
|
2.733 grams per liter (g/L)
Standard Deviation 9.9933
|
—
|
|
Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin)
Haptoglobin
|
0.102 grams per liter (g/L)
Standard Deviation 0.2281
|
-0.012 grams per liter (g/L)
Standard Deviation 0.0286
|
0.528 grams per liter (g/L)
Standard Deviation 0.8312
|
0.000 grams per liter (g/L)
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 12 weeksPopulation: Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
TEAEs were defined as adverse events (AEs) with an onset date later or on the same date as first investigational medicinal product (IMP) intake. The severity grading was determined according to the Common Terminology Criteria for AEs, where the Common Terminology Criteria grades relate to severity as follows: Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening and Grade 5: Death.
Outcome measures
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=6 Participants
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=6 Participants
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 Participants
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
n=1 Participants
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
Any TEAEs
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs related to IMP
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs with severity: Mild
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs with severity: Moderate
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs with severity: Severe
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs with severity: Life threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs with severity: Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=6 participants at risk
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 participants at risk
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=6 participants at risk
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 participants at risk
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
n=1 participants at risk
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
100.0%
1/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
100.0%
1/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
Other adverse events
| Measure |
Cohort 1: VIT-2763 60 mg BID (120 mg/Day)
n=6 participants at risk
Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks.
|
Cohort 2: VIT-2763 120 mg BID (240 mg/Day)
n=6 participants at risk
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks.
|
Cohort 3: VIT-2763 120 mg TID (360 mg/Day)
n=6 participants at risk
Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks.
|
Cohort 4: Placebo
n=6 participants at risk
Participants received placebo capsules, orally, BID or TID for 8 weeks.
|
Cohort 2a: VIT-2763 30 mg BID (60 mg/Day)
n=1 participants at risk
One participant received VIT-2763 30 mg, orally, BID for 8 weeks under Protocol Version 2.0. However, after the implementation of Protocol Version 3.0 and higher, this participant was excluded from the efficacy analysis and only safety data were reported (as planned).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
50.0%
3/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Infections and infestations
Viral infection
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
General disorders
Fatigue
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
General disorders
Pain
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
33.3%
2/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Congenital, familial and genetic disorders
Sickle cell disease
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
100.0%
1/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
100.0%
1/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
|
Vascular disorders
Pallor
|
16.7%
1/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/6 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
0.00%
0/1 • From the first dose of study drug up to 12 weeks
Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place