Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata (NCT NCT05556265)
NCT ID: NCT05556265
Last Updated: 2025-05-31
Results Overview
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region \[24%\], top region \[40%\], left region \[18%\] and, right region \[18%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Baseline (Day 1) and Week 24
Results posted on
2025-05-31
Participant Flow
Study was terminated due to change in business objectives.
94 participants randomized and treated in Placebo controlled period. the 31 participants in the placebo cohort, were re-randomized into the active treatment cohort.
Participant milestones
| Measure |
Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|---|
|
Placebo-Controlled (Day 1 to Week 24)
STARTED
|
32
|
31
|
31
|
0
|
0
|
|
Placebo-Controlled (Day 1 to Week 24)
COMPLETED
|
32
|
26
|
31
|
0
|
0
|
|
Placebo-Controlled (Day 1 to Week 24)
NOT COMPLETED
|
0
|
5
|
0
|
0
|
0
|
|
Active Treatment (Week 25 to Week 52)
STARTED
|
32
|
26
|
0
|
16
|
15
|
|
Active Treatment (Week 25 to Week 52)
COMPLETED
|
8
|
5
|
0
|
5
|
3
|
|
Active Treatment (Week 25 to Week 52)
NOT COMPLETED
|
24
|
21
|
0
|
11
|
12
|
Reasons for withdrawal
| Measure |
Deucravacitinib 6 mg QD
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Deucravacitinib 6 mg BID
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally QD till Week 52 in Active Treatment Period.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|---|
|
Placebo-Controlled (Day 1 to Week 24)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Placebo-Controlled (Day 1 to Week 24)
Participant request to discontinue study treatment
|
0
|
2
|
0
|
0
|
0
|
|
Placebo-Controlled (Day 1 to Week 24)
Adverse Event
|
0
|
2
|
0
|
0
|
0
|
|
Active Treatment (Week 25 to Week 52)
Withdrawal by Subject
|
2
|
2
|
0
|
3
|
1
|
|
Active Treatment (Week 25 to Week 52)
Participant request to discontinue study treatment
|
1
|
3
|
0
|
0
|
1
|
|
Active Treatment (Week 25 to Week 52)
Study terminated by sponsor
|
19
|
12
|
0
|
6
|
9
|
|
Active Treatment (Week 25 to Week 52)
Lost to Follow-up
|
0
|
2
|
0
|
0
|
1
|
|
Active Treatment (Week 25 to Week 52)
Lack of Efficacy
|
1
|
1
|
0
|
1
|
0
|
|
Active Treatment (Week 25 to Week 52)
Adverse Event
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Baseline characteristics by cohort
| Measure |
Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 13.81 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 14.40 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 14.04 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp: back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by it's respective weighting factor (percentage surface area of the scalp in that area; back region \[24%\], top region \[40%\], left region \[18%\] and, right region \[18%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Change From Baseline in Severity of Alopecia Tool Score at Week 24 in Placebo-Controlled Treatment Period
|
-5.809 Score on a Scale
Standard Deviation 13.3892
|
1.027 Score on a Scale
Standard Deviation 14.7258
|
-7.302 Score on a Scale
Standard Deviation 17.8732
|
—
|
PRIMARY outcome
Timeframe: From first dose (Day 1) and up to 30 days after last dose for all participants (up to approximately 28 weeks)Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included herpes zoster, malignancy, opportunistic infection or tuberculosis infection.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
Treatment Emergent Adverse Events
|
25 Participants
|
28 Participants
|
20 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
Serious Treatment Emergent Adverse Events
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
Treatment Emergent Adverse Events Leading to Discontinuation of Study
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
TEAE of Interest-Herpes Zoster
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
TEAE of Interest-Malignancy-Bowen's Disease)
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
TEAE of Interest - Opportunistic Infections
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events in Placebo-Controlled Period
TEAE of Interest - Tuberculosis Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose (Day 1) of Week 25 and up to 30 days after last dose for all participants (up to approximately 28 weeks)Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. Adverse event of interest included Herpes zoster, malignancy, opportunities infection or tuberculosis infection.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=26 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=16 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 Participants
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
Treatment Emergent Adverse Events
|
21 Participants
|
17 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
Serious Treatment Emergent Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
Treatment Emergent Adverse Events Leading to Discontinuation of Study
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
TEAE of Interest-Herpes Zoster
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
TEAE of Interest-Malignancy-Bowen's Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
TEAE of Interest-Malignancy-Nodular lymphocyte predominant Hodgkin Lymphoma
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
TEAE of Interest - Opportunistic Infections
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events in Active Treatment Period
TEAE of Interest - Tuberculosis Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) through Week 24Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
HEMOGLOBIN, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
PLATELET COUNT, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
LEUKOCYTES, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
ALANINE AMINOTRANSFERASE (ALT), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
ALKALINE PHOSPHATASE (ALP), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
ASPARTATE AMINOTRANSFERASE (AST), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
BILIRUBIN, TOTAL, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
CREATININE, ENZYMATIC, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
ALBUMIN, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
CALCIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
CALCIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
CHOLESTEROL, TOTAL (TC), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
CREATINE KINASE (CK), HIGH
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
GLUCOSE, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
POTASSIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
POTASSIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
SODIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
SODIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
TRIGLYCERIDES, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in Placebo-Controlled Period
GLUCOSE FASTING, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From Week 25 to Week 52Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Blood samples were collected for assessment of laboratory test results. All abnormalities are graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=26 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=16 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 Participants
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
TRIGLYCERIDES, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
GLUCOSE FASTING, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
HEMOGLOBIN, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
PLATELET COUNT, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
LEUKOCYTES, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
ALANINE AMINOTRANSFERASE (ALT), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
ALKALINE PHOSPHATASE (ALP), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
ASPARTATE AMINOTRANSFERASE (AST), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
BILIRUBIN, TOTAL, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
CREATININE, ENZYMATIC, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
ALBUMIN, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
CALCIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
CALCIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
CHOLESTEROL, TOTAL (TC), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
CREATINE KINASE (CK), HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
GLUCOSE, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
POTASSIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
POTASSIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
SODIUM, LOW
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Toxicity Grade Change From Baseline to Grade 3/Grade 4 in Laboratory Test Results as Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in in Active Treatment Period
SODIUM, HIGH
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose (Day 1) to Week 24Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with ECG measurements at specified timepoints are included in the analysis.
A 12-lead ECG was performed after the participant remained supine for at least 5 minutes prior to the ECG. The ECG results read by the principal study investigator or a qualified and delegated designee as per local requirements
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=29 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QRS INTERVAL >= 120 MSEC
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QTCF 450 -< 480 MILLISECONDS (MSEC)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QTCF 480 -< 500 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QTCF >= 500 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
QTCF CHANGE FROM BASELINE > 60 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Placebo-Controlled Period
PR INTERVAL >= 200 MSEC
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 25 to Week 52Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with ECG measurements at specified timepoints are included in the analysis.
A 12-lead ECG should be performed after the participant has remained supine for at least 5 minutes prior to the ECG. The ECG results will be read by the principal study investigator or a qualified and delegated designee as per local requirements
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=28 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=19 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=14 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=14 Participants
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QTCF CHANGE FROM BASELINE > 60 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QTCF 450 -< 480 MILLISECONDS (MSEC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QTCF 480 -< 500 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QTCF >= 500 MSEC
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QTCF 30 < CHANGE FROM BASELINE <= 60 MSEC
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
PR INTERVAL >= 200 MSEC
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Electrocardiogram Abnormalities in Active Treatment Period
QRS INTERVAL >= 120 MSEC
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose (Day 1) to Week 24Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with vital sign measurements at specified timepoints are included in the analysis.
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant has been resting quietly for at least 5 minutes.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=30 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Placebo-Controlled Period
DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 25 to Week 52Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention. Participants with vital sign measurements at specified timepoints are included in the analysis.
Vital signs such as systolic blood pressures (SBP), diastolic blood pressure (DBP) and heart rate were assessed. The evaluation of the marked abnormality criteria is based on participants highest change from baseline in the period. Blood pressure and heart rate were to be measured after the participant had been resting quietly for at least 5 minutes.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=26 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=16 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 Participants
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
HEART RATE > 100 BPM AND CHANGE FROM BASELINE > 30 BPM
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
HEART RATE < 55 BPM AND CHANGE FROM BASELINE < -15 BPM
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
SBP >140 MM HG AND CHANGE FROM BASELINE > 20 MM HG
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
SBP <90 MM HG AND CHANGE FROM BASELINE < -20 MM HG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
DBP >90 MM HG AND CHANGE FROM BASELINE > 10 MM HG
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Marked Vital Signs in Active Treatment Period
DBP <55 MM HG AND CHANGE FROM BASELINE < -10 MM HG
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose (Day 1) to Week 24Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Participants were assessed for abnormalities in targeted physical parameters.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
General Appearance
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Genitourinary
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Head, Eyes, Ears, Nose, Throat
|
3 Participants
|
6 Participants
|
2 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Lymph Nodes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Mouth
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Musculoskeletal
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Neck
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Abdomen
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Extremities
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Neurological
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Psychiatric
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Respiratory
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Skin
|
9 Participants
|
14 Participants
|
6 Participants
|
—
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Placebo-Controlled Period
Other
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 25 to Week 52Population: Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
Participants were assessed for abnormalities in targeted physical parameters.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=26 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=16 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 Participants
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Abdomen
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Extremities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
General Appearance
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Genitourinary
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Head, Eyes, Ears, Nose, Throat
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Lymph Nodes
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Mouth
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Musculoskeletal
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Neck
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Neurological
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Other
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Psychiatric
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Respiratory
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Targeted Physical Examination Parameters in Active Treatment Parameters
Skin
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. SALT50 response indicates at least a 50% improvement from baseline in the SALT score at a particular time point, indicating 50% hair regrowth.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a ≥ 50% Reduction in Severity of Alopecia Tool (SALT) Score (SALT50 Response) From Baseline at Week 24
|
3.1 Percentage of participants
|
0 Percentage of participants
|
6.5 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 24Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
The Severity of Alopecia Tool (SALT) score is a quantitative rating scale for measuring the severity of alopecia areata based on the amount of terminal hair loss in each of the 4 quadrants of the scalp; back region, top region, left and right regions of the scalp. To calculate a SALT score, the degree of scalp hair loss, as a percentage of each scalp region affected, is determined. Each region is multiplied by its respective weighting factor (percentage surface area of the scalp in that area; Back region \[24%\], Left Region \[18%\], Right Region \[18%\], Top Region \[40%\]), in order to achieve a subtotal for each region. The SALT score is the sum of the scalp hair loss in each area (sum of the subtotals). The score ranges from 0 to 100, the higher score reflects high severity of alopecia areata. percentage of participants achieving an absolute SALT score ≤ 20, indicates ≤ 20% scalp hair loss.
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and week 24Population: Randomized population includes all participants who were in the enrolled population (who signed informed consent form) and were randomized using Interactive Response Technology (IRT).
The AA-IGA utilizes a 5-points scale, in which the investigator assesses scalp hair loss based on the SALT assessment. The AA-IGA measures alopecia areata severity at a single point in time(without taking into account the baseline disease condition).The participant's scalp hair loss, as it look at the time of evaluation is scored as none (0) (0% scalp hair loss), limited (1) (1%-20% scalp hair loss), moderate (2) (21%-49% scalp hair loss), severe (3) (50%-94% scalp hair loss), or very severe (4)(95%-100 % scalp hair loss).
Outcome measures
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 Participants
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 Participants
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Participants initially randomized to receive placebo in Placebo-controlled period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving an Alopecia Areata Investigator Global Assessment (AA-IGA) Score of 0 or 1 at Week 24 With at Least a 2-Point Change From Baseline
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
Adverse Events
Placebo-Controlled: Deucravacitinib 6 mg QD
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo-Controlled: Deucravacitinib 6 mg BID
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Active-Treatment Period: Deucravacitinib 6 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Active-Treatment Period: Deucravacitinib 6 mg BID
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 participants at risk
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 participants at risk
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 participants at risk
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active-Treatment Period: Deucravacitinib 6 mg QD
n=32 participants at risk
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
|
Active-Treatment Period: Deucravacitinib 6 mg BID
n=26 participants at risk
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
n=16 participants at risk
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib QD tablet orally till Week 52 in Active Treatment Period.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 participants at risk
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular lymphocyte predominant Hodgkin Lymphoma
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Placebo-Controlled: Deucravacitinib 6 mg QD
n=32 participants at risk
Participants with alopecia areata received deucravacitinib 6 mg tablet orally once daily (QD) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo-Controlled: Deucravacitinib 6 mg BID
n=31 participants at risk
Participants with alopecia areata received deucravacitinib 6 mg tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Placebo
n=31 participants at risk
Participants with alopecia areata received placebo tablet orally twice daily (BID) from Day 1 to Week 24 in Placebo-controlled Period.
|
Active-Treatment Period: Deucravacitinib 6 mg QD
n=32 participants at risk
Participants initially randomized to deucravacitinib 6 mg QD in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
|
Active-Treatment Period: Deucravacitinib 6 mg BID
n=26 participants at risk
Participants initially randomized to deucravacitinib 6 mg BID in Placebo-controlled Period continued on their assigned dosage in Active Treatment Period till Week 52.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg QD
n=16 participants at risk
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib QD tablet orally till Week 52 in Active Treatment Period.
|
Active-Treatment Period: Placebo Followed by Deucravacitinib 6 mg BID
n=15 participants at risk
Participants initially randomized to receive placebo in Placebo-controlled Period were re-randomized to this arm at the Week 24 visit. Participants in this arm received 6 mg deucravacitinib tablet orally BID till Week 52 in Active Treatment Period.
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.5%
2/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Amalgam tattoo
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
9.4%
3/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.9%
4/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
7.7%
2/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
13.3%
2/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.9%
4/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
13.3%
2/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
General disorders
Mass
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
9.4%
3/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
13.3%
2/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Cystitis
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Folliculitis
|
15.6%
5/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
19.4%
6/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
7.7%
2/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Influenza
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Nail infection
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
5/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
25.8%
8/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
23.1%
6/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.5%
2/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Oral herpes
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Pharyngitis
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
7.7%
2/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Tonsillitis
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.9%
4/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.9%
4/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.5%
4/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
19.2%
5/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
25.0%
4/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
26.7%
4/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
9.7%
3/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.8%
1/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Investigations
Weight increased
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
2/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.5%
2/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
9.7%
3/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
9.7%
3/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
9.4%
3/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.2%
1/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.2%
1/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
7.7%
2/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Acne
|
15.6%
5/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
12.9%
4/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
9.7%
3/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
18.8%
3/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
26.7%
4/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/31 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
3.1%
1/32 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/26 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
0.00%
0/16 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
|
6.7%
1/15 • All cause mortality was collected from Week 0 to Week 52. Serious AEs were collected from informed consent form signing (Week -4) and up to 30 days after last dose for all participants (up to approximately 32 weeks and 28 weeks in Placebo-controlled and Active Treatment Period respectively). Non Serious AEs were collected from first dose (Day 1) and up to 30 days after last dose (up to approximately 28 weeks for each Placebo-controlled and Active Treatment Period).
Safety population included all participants who were in the randomized population and received at least 1 dose of study intervention.
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Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER