Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF (NCT NCT04533022)
NCT ID: NCT04533022
Last Updated: 2025-05-23
Results Overview
Number of participants with adverse events occurring over the trial period incl. number of participants with any TEAE, serious TEAEs, TEAEs leading to withdrawal from trial, TEAEs leading to discontinuation of treatment, treatment-related TEAEs leading to discontinuation of treatment, TEAEs leading to death, and serious treatment-related TEAEs. Adverse events were recorded from signing of informed consent until end of trial. Nature and frequency of adverse events are presented in details in the adverse events section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Trial period of 36 weeks
Results posted on
2025-05-23
Participant Flow
52 participants were enrolled and received at least one dose of C21. 138 participants signed informed content and were screened, however, 86 of those were screening failures and thus not enrolled.
Participant milestones
| Measure |
C21 100 mg BID
Oral administration of 100 mg BID C21 (200 mg daily)
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
C21 100 mg BID
Oral administration of 100 mg BID C21 (200 mg daily)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Death
|
1
|
|
Overall Study
FVC decline and FVCpp<60%
|
2
|
|
Overall Study
FVC decline, FVCpp<60% and worsening of respiratory symptoms
|
1
|
Baseline Characteristics
Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF
Baseline characteristics by cohort
| Measure |
C21 100 mg BID, SAS
n=52 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Age, Continuous
|
67.3 Years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
|
Region of Enrollment
India
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
3 participants
n=5 Participants
|
|
Height
|
161.69 cm
STANDARD_DEVIATION 8.723 • n=5 Participants
|
|
Weight
|
64.64 kg
STANDARD_DEVIATION 14.178 • n=5 Participants
|
|
Body mass index
|
24.57 kg/m^2
STANDARD_DEVIATION 4.119 • n=5 Participants
|
|
Smoking status
Current
|
0 Participants
n=5 Participants
|
|
Smoking status
Former
|
10 Participants
n=5 Participants
|
|
Smoking status
Never
|
42 Participants
n=5 Participants
|
|
Smoking status
Missing
|
0 Participants
n=5 Participants
|
|
E-cigarettes and vapes status
Current
|
0 Participants
n=5 Participants
|
|
E-cigarettes and vapes status
Former
|
1 Participants
n=5 Participants
|
|
E-cigarettes and vapes status
Never
|
51 Participants
n=5 Participants
|
|
E-cigarettes and vapes status
Missing
|
0 Participants
n=5 Participants
|
|
Time since diagnosis of idiopathic pulmonary fibrosis
|
1.01 Years
STANDARD_DEVIATION 1.195 • n=5 Participants
|
|
Oxygen saturation at screening
|
95.3 Percentage of oxygen saturation
STANDARD_DEVIATION 2.40 • n=5 Participants
|
|
FEV1
|
1.912 L
STANDARD_DEVIATION 0.528 • n=5 Participants
|
|
FVC
|
2.387 L
STANDARD_DEVIATION 0.667 • n=5 Participants
|
|
FEV1/FVC
|
0.804 ratio
STANDARD_DEVIATION 0.067 • n=5 Participants
|
|
FEV1 (% predicted normal)
|
77.51 Percentage of predicted normal FEV1
STANDARD_DEVIATION 14.687 • n=5 Participants
|
|
FVC (% predicted normal)
|
75.46 Percentage of predicted normal FVC
STANDARD_DEVIATION 13.662 • n=5 Participants
|
|
Age of High-resolution computed tomography (HRCT) scan
|
5.58 Months
STANDARD_DEVIATION 8.720 • n=5 Participants
|
|
Previous use of antifibrotics
Nintedanib
|
0 Participants
n=5 Participants
|
|
Previous use of antifibrotics
Pirfenidone
|
0 Participants
n=5 Participants
|
|
HRCT pattern (central reading)
Typical usual interstitial pneumonitis (UIP) HRCT Pattern
|
20 Participants
n=5 Participants
|
|
HRCT pattern (central reading)
Probable UIP HRCT Pattern
|
32 Participants
n=5 Participants
|
|
HRCT pattern (central reading)
HRCT Feature most consistent with Non-IPF diagnosis
|
0 Participants
n=5 Participants
|
|
HRCT pattern (central reading)
Missing
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Trial period of 36 weeksPopulation: Safety analysis set
Number of participants with adverse events occurring over the trial period incl. number of participants with any TEAE, serious TEAEs, TEAEs leading to withdrawal from trial, TEAEs leading to discontinuation of treatment, treatment-related TEAEs leading to discontinuation of treatment, TEAEs leading to death, and serious treatment-related TEAEs. Adverse events were recorded from signing of informed consent until end of trial. Nature and frequency of adverse events are presented in details in the adverse events section.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=52 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with treatment-emergent adverse events (TEAEs)
|
37 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with serious TEAEs
|
5 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with TEAEs leading to withdrawal from study
|
6 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with TEAEs leading to discontinuation of treatment
|
12 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with treatment-related TEAEs leading to discontinuation of treatment
|
3 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with TEAEs leading to death
|
2 Participants
|
|
Number of Participants With Adverse Events Occurring Over the Trial Period
Total number of subjects with serious treatment-related TEAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: 12, 24, and 36 weeksPopulation: Participants in the Full analysis set (FAS) with a measurement.
Mean changes in forced vital capacity (FVC) (mL) from baseline to week 12, week 24, and week 36 were calculated
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=35 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Change From Baseline in Forced Vital Capacity (Non-imputed Data)
Week 12
|
-4.9 mL
Interval -73.2 to 63.4
|
|
Change From Baseline in Forced Vital Capacity (Non-imputed Data)
Week 24
|
16.0 mL
Interval -117.4 to 149.3
|
|
Change From Baseline in Forced Vital Capacity (Non-imputed Data)
Week 36
|
216.0 mL
Interval 36.9 to 395.1
|
SECONDARY outcome
Timeframe: 12, 24, and 36 weeksPopulation: Full analysis set with imputed data
Mean changes in forced vital capacity (FVC) (mL) from baseline to week 12, week 24, and week 36 were calculated
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=48 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Change From Baseline in Forced Vital Capacity (Imputed Data)
Week 36
|
9.4 mL
Interval -115.6 to 134.4
|
|
Change From Baseline in Forced Vital Capacity (Imputed Data)
Week 12
|
-57.6 mL
Interval -123.3 to 8.1
|
|
Change From Baseline in Forced Vital Capacity (Imputed Data)
Week 24
|
-70.3 mL
Interval -170.5 to 29.9
|
SECONDARY outcome
Timeframe: 12, 24, and 36 weeksPopulation: Full analysis set
Model-based mean (90% CI) FVC changes over 12, 24, and 36 weeks were normalized to change over 24 weeks. A piece-wise linear regression model with knots at weeks 6 and 24 and unstructured covariance matrix was fitted to change from baseline data. Knot selection was performed by visual inspection. The model based change over 12, 24, and 36 weeks was normalized to represent a change over 24 weeks. Rate of decline was computed as y(t) - y(0) = t\*Beta1 + max(0, t-6)\*Beta2 + max(0,t-24)\*Beta3, adjusted to show the decline per 24 weeks, where y is the value at the respective week and Beta is the model coefficient. No imputation of data was conducted.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=50 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Rate of Forced Vital Capacity Decline Over Time, FAS
Week 12
|
-8.2 mL
Interval -141.9 to 125.5
|
|
Rate of Forced Vital Capacity Decline Over Time, FAS
Week 24
|
36.4 mL
Interval -87.1 to 160.0
|
|
Rate of Forced Vital Capacity Decline Over Time, FAS
Week 36
|
108.9 mL
Interval -4.8 to 222.6
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose on Day 1The plasma concentration of C21 (ng/mL) was calculated in a subset of subjects at specified timepoints post-dose.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=12 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
Prior to dosing
|
5.00 ng/mL
Standard Deviation 0.00
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
30 min post dose
|
1622.0 ng/mL
Standard Deviation 1453.64
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
1 h post dose
|
1788.11 ng/mL
Standard Deviation 1112.48
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
2 h post dose
|
864.46 ng/mL
Standard Deviation 1062.15
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
3 h post dose
|
322.19 ng/mL
Standard Deviation 407.29
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Day 1
4 h post dose
|
282.82 ng/mL
Standard Deviation 379.31
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 12The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 12 weeks of dosing.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=8 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
Prior to dosing
|
27.13 ng/mL
Standard Deviation 62.58
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
30 min post dose
|
974.28 ng/mL
Standard Deviation 1028.90
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
1 h post dose
|
1044.02 ng/mL
Standard Deviation 1128.30
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
2 h post dose
|
794.02 ng/mL
Standard Deviation 774.34
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
3 h post dose
|
491.25 ng/mL
Standard Deviation 820.36
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 12
4 h post dose
|
101.50 ng/mL
Standard Deviation 113.96
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 24The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 24 weeks of dosing.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=9 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
Prior to dosing
|
20.14 ng/mL
Standard Deviation 28.608
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
30 min post dose
|
615.53 ng/mL
Standard Deviation 792.908
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
1 h post dose
|
898.61 ng/mL
Standard Deviation 779.723
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
2 h post dose
|
404.80 ng/mL
Standard Deviation 296.002
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
3 h post dose
|
151.30 ng/mL
Standard Deviation 125.292
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 24
4 h post dose
|
115.93 ng/mL
Standard Deviation 151.833
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Week 36The plasma concentration of C21 (ng/mL) was calculated at specified timepoints post-dose after 36 weeks of dosing.
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=9 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
Prior to dosing
|
89.78 ng/mL
Standard Deviation 176.452
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
30 min post dose
|
796.29 ng/mL
Standard Deviation 839.353
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
1 h post dose
|
713.86 ng/mL
Standard Deviation 453.540
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
2 h post dose
|
298.29 ng/mL
Standard Deviation 299.235
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
3 h post dose
|
374.16 ng/mL
Standard Deviation 459.545
|
|
Plasma Concentration of C21 Evaluated in a Sub-set of Subjects, Week 36
4 h post dose
|
348.11 ng/mL
Standard Deviation 479.786
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36The maximal plasma concentration (Cmax (ng/ml)) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=12 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Cmax in a Sub-set of Subjects
0 Weeks
|
1852.13 ng/mL
Geometric Coefficient of Variation 80.1
|
|
Cmax in a Sub-set of Subjects
12 Weeks
|
954.29 ng/mL
Geometric Coefficient of Variation 127.9
|
|
Cmax in a Sub-set of Subjects
24 Weeks
|
524.79 ng/mL
Geometric Coefficient of Variation 281.6
|
|
Cmax in a Sub-set of Subjects
36 Weeks
|
961.86 ng/mL
Geometric Coefficient of Variation 73.3
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36The time for the maximal plasma concentration (Tmax (h)) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=12 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Tmax in a Sub-set of Subjects
Week 0
|
1.00 h
Interval 0.5 to 4.0
|
|
Tmax in a Sub-set of Subjects
Week 12
|
1.50 h
Interval 0.5 to 4.0
|
|
Tmax in a Sub-set of Subjects
Week 24
|
1.00 h
Interval 0.0 to 1.0
|
|
Tmax in a Sub-set of Subjects
Week 36
|
1.00 h
Interval 0.5 to 4.0
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36Area under the plasma concentration time curve to the last quantified concentration (AUClast) (h\*ng/mL) was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=12 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
AUClast in a Sub-set of Subjects
Week 0
|
3018.151 h*ng/mL
Geometric Coefficient of Variation 60.5
|
|
AUClast in a Sub-set of Subjects
Week 12
|
1704.924 h*ng/mL
Geometric Coefficient of Variation 126.6
|
|
AUClast in a Sub-set of Subjects
Week 24
|
995.600 h*ng/mL
Geometric Coefficient of Variation 213.2
|
|
AUClast in a Sub-set of Subjects
Week 36
|
1622.774 h*ng/mL
Geometric Coefficient of Variation 49.8
|
SECONDARY outcome
Timeframe: Prior to dosing, 30 min post dose, 1 h post dose, 2 h post dose, 3 h post dose, and 4 h post dose at Weeks 0, 12, 24, and 36Accumulation ratio AUC was calculated in a subset of subjects after 0, 12, 24, and 36 weeks of dosing
Outcome measures
| Measure |
C21 100 mg BID, SAS
n=12 Participants
Oral administration of 100 mg BID C21 (200 mg daily) Safety analysis set (SAS)
|
|---|---|
|
Accumulation Ratio AUC in a Sub-set of Subjects
Week 36
|
0.73765 Ratio
Geometric Coefficient of Variation 67.9
|
|
Accumulation Ratio AUC in a Sub-set of Subjects
Week 12
|
0.84598 Ratio
Geometric Coefficient of Variation 120.5
|
|
Accumulation Ratio AUC in a Sub-set of Subjects
Week 24
|
0.45256 Ratio
Geometric Coefficient of Variation 328.9
|
Adverse Events
C21 100 mg BID
Serious events: 5 serious events
Other events: 35 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
C21 100 mg BID
n=52 participants at risk
Oral administration of 100 mg BID C21 (200 mg daily)
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Cardiac disorders
Cardiac failure
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Infections and infestations
COVID-19
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Infections and infestations
Kidney infection
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Cardiac disorders
Sepsis
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
1.9%
1/52 • Number of events 1 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
Other adverse events
| Measure |
C21 100 mg BID
n=52 participants at risk
Oral administration of 100 mg BID C21 (200 mg daily)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
10/52 • Number of events 10 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
4/52 • Number of events 6 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
7.7%
4/52 • Number of events 4 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
3/52 • Number of events 6 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
Blood creatinine increased
|
7.7%
4/52 • Number of events 4 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
C-reactive protein increased
|
5.8%
3/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
Blood alkaline phosphatase increased
|
3.8%
2/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
Blood glucose increased
|
3.8%
2/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
Alanine aminotransferase abnormal
|
1.9%
1/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Investigations
Aspartate aminotransferase abnormal
|
1.9%
1/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Infections and infestations
Lower respiratory tract infection
|
5.8%
3/52 • Number of events 4 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
4/52 • Number of events 5 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.8%
3/52 • Number of events 5 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
3.8%
2/52 • Number of events 6 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Cardiac disorders
Bundle branch block left
|
5.8%
3/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
General disorders
Pyrexia
|
7.7%
4/52 • Number of events 4 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
General disorders
Influenza like illness
|
1.9%
1/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Number of events 8 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Nervous system disorders
Lethargy
|
5.8%
3/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Psychiatric disorders
Insomnia
|
3.8%
2/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Number of events 3 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
2/52 • Number of events 2 • Throughout the trial from signing of informed consent until the end-of-trial visit, up to 44 weeks
At each visit the subject was asked about AEs in an objective manner, e.g.: "Have you experienced any problems since the last visit?"
|
Additional Information
Chief medical officer Bertil Lindmark
Vicore Pharma AB
Phone: +46 707661505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place