Trial Outcomes & Findings for Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata (NCT NCT03941548)
NCT ID: NCT03941548
Last Updated: 2023-04-05
Results Overview
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2023-04-05
Participant Flow
Participants were enrolled at 12 study centers in Canada and the United States from 24 May 2019 to 10 April 2020.
94 participants were screened out of which 66 participants who experienced an episode of hair loss due to alopecia areata were enrolled and randomized to receive CTP-543 12 milligrams (mg) twice daily (BID) or CTP-543 24 mg once daily (QD).
Participant milestones
| Measure |
CTP-543 12 mg BID
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
Safety Population
|
34
|
32
|
|
Overall Study
mITT Population
|
34
|
32
|
|
Overall Study
COMPLETED
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
CTP-543 12 mg BID
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal of Informed Consent due to an Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy and Tolerability Study of Two Dosing Regimens of CTP-543 in Adults With Alopecia Areata
Baseline characteristics by cohort
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 11.89 • n=93 Participants
|
40.4 years
STANDARD_DEVIATION 14.20 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 12.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Severity of Alopecia Tool (SALT) Score
|
85.77 score on a scale
STANDARD_DEVIATION 19.473 • n=93 Participants
|
87.76 score on a scale
STANDARD_DEVIATION 17.280 • n=4 Participants
|
86.73 score on a scale
STANDARD_DEVIATION 18.328 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Outcome measures
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
|
58.44 percent change
Standard Deviation 34.747
|
51.96 percent change
Standard Deviation 37.887
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Percentage of participants achieving at least a 50%, 75%, 90% relative reduction in SALT score from baseline at Weeks 4, 8, 12, 16, 20, and 24 are reported.
Outcome measures
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 20
|
32.4 percentage of participants
|
21.9 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 24
|
32.4 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 12
|
14.7 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 16
|
23.5 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 20
|
35.3 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 24
|
38.2 percentage of participants
|
34.4 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 8
|
8.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 20
|
52.9 percentage of participants
|
43.8 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 24
|
61.8 percentage of participants
|
53.1 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 12
|
8.8 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
90% Reduction: Week 16
|
20.6 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
75% Reduction: Week 8
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 12
|
32.4 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Achieving at Least a 90%, 75%, and 50% Reduction in SALT Score From Baseline
50% Reduction: Week 16
|
44.1 percentage of participants
|
40.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Absolute change equals the difference in SALT measurements (baseline SALT score - follow-up SALT score).
Outcome measures
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 4
|
1.95 score on a scale
Standard Deviation 4.247
|
3.02 score on a scale
Standard Deviation 5.211
|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 8
|
11.68 score on a scale
Standard Deviation 17.674
|
13.61 score on a scale
Standard Deviation 15.795
|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 16
|
38.83 score on a scale
Standard Deviation 30.699
|
31.32 score on a scale
Standard Deviation 28.637
|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 20
|
45.44 score on a scale
Standard Deviation 32.169
|
37.78 score on a scale
Standard Deviation 31.021
|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 24
|
48.63 score on a scale
Standard Deviation 31.733
|
42.82 score on a scale
Standard Deviation 31.470
|
|
Absolute Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16, 20, and 24
Change from Baseline at Week 12
|
26.07 score on a scale
Standard Deviation 28.086
|
25.33 score on a scale
Standard Deviation 27.874
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16 and 20Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized.
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
Outcome measures
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 4
|
3.12 percent change
Standard Deviation 7.474
|
3.95 percent change
Standard Deviation 7.126
|
|
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 8
|
14.57 percent change
Standard Deviation 19.800
|
17.24 percent change
Standard Deviation 19.034
|
|
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 12
|
32.10 percent change
Standard Deviation 30.960
|
31.90 percent change
Standard Deviation 33.820
|
|
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 20
|
54.58 percent change
Standard Deviation 35.582
|
46.24 percent change
Standard Deviation 37.891
|
|
Relative Change From Baseline in SALT Scores at Weeks 4, 8, 12, 16 and 20
Change from Baseline at Week 16
|
47.20 percent change
Standard Deviation 34.663
|
39.08 percent change
Standard Deviation 35.750
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8, 12 and 24Population: mITT Population included all randomized participants who received at least one dose of study drug and had at least 1 post-treatment SALT assessment. Participants were summarized according to study drug regimen to which they were randomized, with data available for analysis. Number analyzed indicates the number of participants with available data for analysis at the specific timepoint.
Participant satisfaction question was used to assess overall satisfaction with hair coverage, with responses ranging from 1 to 5, as follows: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat satisfied), 4 (mostly satisfied), 5 (very satisfied). Higher scores indicate better satisfaction with hair coverage. The percentage of participants with change from Baseline to Weeks 8, 12 and 24 satisfaction level was reported as categories: satisfied to satisfied; satisfied to dissatisfied; dissatisfied to satisfied and dissatisfied to dissatisfied. Data is reported only for participants with change from Baseline in satisfaction level.
Outcome measures
| Measure |
CTP-543 12 mg BID
n=32 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=31 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 8: Satisfied to Satisfied
|
3.6 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 8: Satisfied to Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 8: Dissatisfied to Satisfied
|
39.3 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 8: Dissatisfied to Dissatisfied
|
57.1 percentage of participants
|
55.2 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 12: Satisfied to Satisfied
|
6.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 12: Satisfied to Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 12: Dissatisfied to Satisfied
|
35.5 percentage of participants
|
67.7 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 12: Dissatisfied to Dissatisfied
|
58.1 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 24: Satisfied to Satisfied
|
6.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 24: Satisfied to Dissatisfied
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 24: Dissatisfied to Satisfied
|
68.8 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With Change in Satisfaction of Hair Coverage From Baseline
Week 24: Dissatisfied to Dissatisfied
|
25.0 percentage of participants
|
30.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dose up to 28 weeksPopulation: Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event.
Outcome measures
| Measure |
CTP-543 12 mg BID
n=34 Participants
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 Participants
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
|
28 Participants
|
24 Participants
|
Adverse Events
CTP-543 12 mg BID
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
CTP-543 24 mg QD
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTP-543 12 mg BID
n=34 participants at risk
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 participants at risk
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
Other adverse events
| Measure |
CTP-543 12 mg BID
n=34 participants at risk
Participants received 1 x 12 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, BID for 24 weeks.
|
CTP-543 24 mg QD
n=32 participants at risk
Participants received 24 mg (2 x 12 mg) CTP-543 tablets, QD and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
6.2%
2/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Fatigue
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Seasonal allergy
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Folliculitis
|
0.00%
0/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
9.4%
3/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Nasopharyngitis
|
11.8%
4/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
9.4%
3/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Sinusitis
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Upper respiratory tract infection
|
11.8%
4/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
18.8%
6/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
General disorders
Urinary tract infection
|
2.9%
1/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
9.4%
3/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Amylase increased
|
8.8%
3/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
3/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Blood bicarbonate decreased
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Blood creatine phosphokinase increased
|
32.4%
11/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
12.5%
4/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Blood potassium increased
|
8.8%
3/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
6.2%
2/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Lipase increased
|
11.8%
4/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
6.2%
2/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
Weight increased
|
8.8%
3/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
9.4%
3/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
6.2%
2/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
3.1%
1/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
18.8%
6/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.9%
1/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
12.5%
4/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Skin and subcutaneous tissue disorders
Acne
|
11.8%
4/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
6.2%
2/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.9%
2/34 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
0.00%
0/32 • From first dose up to 28 weeks
Safety population included all participants who received at least one dose of study drug. Participants were summarized according to study drug regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an Investigator wants to publish study data or results, the publication or presentation must be provided to Concert for review at least 60 days in advance. If Concert needs to file a patent application prior to publication, the publication can be delayed up to 90 days from Sponsor providing notice to the investigator of such need.
- Publication restrictions are in place
Restriction type: OTHER