Trial Outcomes & Findings for Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis (NCT NCT03410056)
NCT ID: NCT03410056
Last Updated: 2021-06-22
Results Overview
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
Results posted on
2021-06-22
Participant Flow
Participants in phase 1b were to be enrolled into 1 of 4 planned dosing cohorts and randomized in a 3:1 ratio to receive Efavaleukin alfa or placebo according to 1 of 2 dosing schedules; A (less frequent) and B (more frequent).
Enrollment of the phase 1b part of this study was stopped as of 30 September 2019, due to data that suggested that there is not sufficient benefit-risk for the use of Efavaleukin alfa plus standard of care therapy in this study population. The study was terminated prior to the enrollment of any participants into phase 1b Cohort 4 and phase 2a cohorts.
Participant milestones
| Measure |
Phase 1b: Placebo
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 4
A medium/high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
No participants were enrolled into this cohort as the study was terminated prior to initiation of Cohort 4.
|
Phase 2a: Placebo
Matching placebo administered via subcutaneous injection, depending on the recommended phase 2 dose (RP2D) and dosing schedule as determined in phase 1b, for a total of up to 12 weeks.
The study was terminated prior to the start of phase 2a and no participants were enrolled.
|
Phase 2a: Efavaleukin Alfa
Efavaleukin alfa administered via subcutaneous injection depending on the RP2D and dosing schedule determined in phase 1b, for up to a total of up to 12 weeks.
The study was terminated prior to the start of phase 2a and no participants were enrolled.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
11
|
11
|
0
|
0
|
0
|
|
Overall Study
Received Treatment
|
8
|
6
|
11
|
11
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
4
|
3
|
6
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
8
|
5
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1b: Placebo
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 4
A medium/high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
No participants were enrolled into this cohort as the study was terminated prior to initiation of Cohort 4.
|
Phase 2a: Placebo
Matching placebo administered via subcutaneous injection, depending on the recommended phase 2 dose (RP2D) and dosing schedule as determined in phase 1b, for a total of up to 12 weeks.
The study was terminated prior to the start of phase 2a and no participants were enrolled.
|
Phase 2a: Efavaleukin Alfa
Efavaleukin alfa administered via subcutaneous injection depending on the RP2D and dosing schedule determined in phase 1b, for up to a total of up to 12 weeks.
The study was terminated prior to the start of phase 2a and no participants were enrolled.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Decision by Sponsor
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
5
|
5
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
53.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
51.9 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: The safety analysis set: All participants who received at least 1 dose of investigational product. Only cohorts with enrolled participants are included.
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated. Serious adverse events (SAEs) were defined as meeting at least 1 of the following criteria: * Results in death (fatal) * Immediately life-threatening * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other medically important serious event
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs
|
3 Participants
|
5 Participants
|
11 Participants
|
11 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Grade ≥ 2 TEAEs
|
2 Participants
|
3 Participants
|
8 Participants
|
8 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Grade ≥ 3 TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Grade ≥ 4 TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs leading to discontinuation of study treatment
|
0 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Life-threatening TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Fatal TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: The safety analysis set: All participants who received at least 1 dose of investigational product. Only cohorts with enrolled participants are included.
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: The safety analysis set: All participants who received at least 1 dose of investigational product. Only cohorts with enrolled participants are included.
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Laboratory Safety Tests
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of treatment maximum of 12 weeksPopulation: The safety analysis set: All participants who received at least 1 dose of investigational product. Only cohorts with enrolled participants are included.
Any changes in ECG parameters that were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
ACR 20 response defined as at least 20 percent improvement from baseline in both tender and swollen joint counts, and a 20 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-dose), 6 and 12 hours post-dose, and days 2, 3, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and Day 85 (pre-dose), 6 and 12 hours post-dose and days 86, 87, 88, 92, 99, 113 and 127Population: The pharmacokinetic (PK) analysis set: All participants who received at least one dose of Efavaleukin alfa and had at least one quantifiable PK sample collected. Only participants with PK data available for analysis are presented. Only cohorts with enrolled participants are included.
A summary of mean serum concentrations of Efavaleukin alfa over time is presented. Any results below the lower limit of quantification were set to 0.00.
Outcome measures
| Measure |
Phase 1b: Placebo
n=6 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=11 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 1 (pre-dose)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 1 (6 hours post-dose)
|
1.35 ng/mL
Standard Deviation 0.795
|
7.67 ng/mL
Standard Deviation 8.01
|
2.13 ng/mL
Standard Deviation 2.98
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 1 (12 hours post-dose)
|
2.43 ng/mL
Standard Deviation 0.867
|
14.6 ng/mL
Standard Deviation 12.1
|
4.09 ng/mL
Standard Deviation 4.70
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 2
|
2.59 ng/mL
Standard Deviation 0.875
|
22.0 ng/mL
Standard Deviation 11.5
|
5.44 ng/mL
Standard Deviation 5.09
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 3
|
1.70 ng/mL
Standard Deviation 0.850
|
18.6 ng/mL
Standard Deviation 9.16
|
3.65 ng/mL
Standard Deviation 3.13
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 4
|
0.727 ng/mL
Standard Deviation 0.277
|
7.65 ng/mL
Standard Deviation 5.85
|
2.36 ng/mL
Standard Deviation 2.84
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 8
|
0.0555 ng/mL
Standard Deviation 0.0924
|
0.108 ng/mL
Standard Deviation 0.146
|
0.0284 ng/mL
Standard Deviation 0.0624
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 11
|
0.0230 ng/mL
Standard Deviation 0.0514
|
0.0115 ng/mL
Standard Deviation 0.0364
|
0.930 ng/mL
Standard Deviation 0.780
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 15
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.107 ng/mL
Standard Deviation 0.150
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 22
|
0.0830 ng/mL
Standard Deviation 0.144
|
0.0703 ng/mL
Standard Deviation 0.112
|
0.235 ng/mL
Standard Deviation 0.373
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 29
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.217 ng/mL
Standard Deviation 0.344
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 36
|
0.0644 ng/mL
Standard Deviation 0.144
|
0.102 ng/mL
Standard Deviation 0.203
|
0.239 ng/mL
Standard Deviation 0.425
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 43
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.104 ng/mL
Standard Deviation 0.275
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 50
|
0.205 ng/mL
Standard Deviation 0.304
|
0.105 ng/mL
Standard Deviation 0.210
|
0.122 ng/mL
Standard Deviation 0.322
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 57
|
0.0368 ng/mL
Standard Deviation 0.0735
|
0.00 ng/mL
Standard Deviation 0.00
|
0.0886 ng/mL
Standard Deviation 0.234
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 64
|
0.336 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.212 ng/mL
Standard Deviation 0.424
|
0.0294 ng/mL
Standard Deviation 0.0657
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 71
|
0.0635 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 78
|
0.154 ng/mL
Standard Deviation 0.267
|
0.355 ng/mL
Standard Deviation 0.614
|
0.0508 ng/mL
Standard Deviation 0.0819
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 85 (pre-dose)
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
0.0578 ng/mL
Standard Deviation 0.0958
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 85 (6 hours post-dose)
|
2.41 ng/mL
Standard Deviation 1.56
|
5.91 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
1.92 ng/mL
Standard Deviation 2.64
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 85 (12 hours post-dose)
|
4.00 ng/mL
Standard Deviation 2.05
|
12.9 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
2.92 ng/mL
Standard Deviation 4.03
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 86
|
3.60 ng/mL
Standard Deviation 2.07
|
12.3 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
2.97 ng/mL
Standard Deviation 4.48
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 87
|
2.10 ng/mL
Standard Deviation 1.15
|
4.39 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
1.87 ng/mL
Standard Deviation 2.43
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 88
|
1.48 ng/mL
Standard Deviation 0.623
|
1.01 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.903 ng/mL
Standard Deviation 1.17
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 92
|
0.113 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.00 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.0953 ng/mL
Standard Deviation 0.115
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 99
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.110 ng/mL
Standard Deviation 0.268
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 113
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
Phase 1b: Efavaleukin Alfa Serum Concentrations
Day 127
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation NA
Insufficient samples were collected to assess SD.
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and days 92, 99, 113 and 127Population: The PK analysis set: All participants who received at least one dose of Efavaleukin alfa and had at least one quantifiable PK sample collected. Only participants with PK data available for analysis are presented. Only cohorts with enrolled participants are included.
Outcome measures
| Measure |
Phase 1b: Placebo
n=6 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=11 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
First dose (Day 1)
|
2.66 ng/mL
Standard Deviation 0.852
|
23.0 ng/mL
Standard Deviation 11.2
|
5.71 ng/mL
Standard Deviation 5.10
|
—
|
|
Phase 1b: Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa
Last dose (Day 85)
|
4.00 ng/mL
Standard Deviation 2.05
|
NA ng/mL
Standard Deviation NA
Insufficient samples were collected to assess mean Cmax.
|
3.22 ng/mL
Standard Deviation 4.35
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and days 92, 99, 113 and 127Population: The PK analysis set: All participants who received at least one dose of Efavaleukin alfa and had at least one quantifiable PK sample collected. Only participants with PK data available for analysis are presented. Only cohorts with enrolled participants are included.
Outcome measures
| Measure |
Phase 1b: Placebo
n=6 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=11 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Time to Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
First dose (Day 1)
|
18 hours
Interval 12.0 to 24.0
|
24 hours
Interval 24.0 to 48.0
|
24 hours
Interval 12.0 to 72.0
|
—
|
|
Phase 1b: Time to Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa
Last dose (Day 85)
|
12 hours
Interval 12.0 to 12.0
|
30 hours
Interval 12.0 to 48.0
|
12 hours
Interval 6.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4, 8, 11 and 15, Day 85 (pre-dose) and 6 to 72 hours post-dose, and days 92 and 99Population: The PK analysis set: All participants who received at least one dose of Efavaleukin alfa and had at least one quantifiable PK sample collected. Only participants with PK data available for analysis are presented. Only cohorts with enrolled participants are included.
AUC0-14 was only assessed for the participants who received Efavaleukin alfa using dosing schedule A.
Outcome measures
| Measure |
Phase 1b: Placebo
n=6 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=10 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 14 Days (AUC0-14) Post Dose
First dose (Day 1)
|
167 hr*ng/mL
Standard Deviation 60.9
|
1570 hr*ng/mL
Standard Deviation 859
|
—
|
—
|
|
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 14 Days (AUC0-14) Post Dose
Last dose (Day 85)
|
282 hr*ng/mL
Standard Deviation 207
|
NA hr*ng/mL
Standard Deviation NA
Insufficient samples were collected to assess AUC0-14
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and 6 to 48 hours post-dose, and days 4 and 8, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Day 92Population: The PK analysis set: All participants who received at least one dose of Efavaleukin alfa and had at least one quantifiable PK sample collected. Only participants with PK data available for analysis are presented. Only cohorts with enrolled participants are included.
AUC0-7 was only assessed for the participants who received Efavaleukin alfa using dosing schedule B.
Outcome measures
| Measure |
Phase 1b: Placebo
n=10 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 7 Days (AUC0-7) Post Dose
First dose (Day 1)
|
315 hr*ng/mL
Standard Deviation 239
|
—
|
—
|
—
|
|
Phase 1b: Area Under the Concentration-time Curve From Time 0 to 7 Days (AUC0-7) Post Dose
Last dose (Day 85)
|
195 hr*ng/mL
Standard Deviation 264
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: All participants who received at least 1 dose of investigational product and had a baseline and at least 1 post-baseline result. Only participants who tested positive for anti-Efavaleukin alfa antibodies were analyzed for presence of anti-IL2 binding antibodies. Only cohorts with enrolled participants are included.
Number of participants who tested positive for anti-Efavaleukin alfa binding antibodies and number of those participants who cross-reacted with native human IL-2 (i.e. with anti-IL-2 binding antibodies) are reported.
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies
Binding anti-AMG 592 antibody positive post-baseline with a negative or no result at baseline
|
2 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
|
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies
Binding anti-IL2 antibody positive post-baseline with a negative or no result at baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: All participants who received at least 1 dose of investigational product and had a baseline and at least 1 post-baseline result. Only participants who tested positive for anti-Efavaleukin alfa antibodies were analyzed for presence of anti-IL2 neutralizing antibodies. Only cohorts with enrolled participants are included.
The number of participants who tested positive for anti-Efavaleukin alfa neutralizing antibodies and number of participants with anti-IL2 neutralizing antibodies who tested negative or no result at baseline are reported.
Outcome measures
| Measure |
Phase 1b: Placebo
n=8 Participants
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=5 Participants
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 Participants
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=10 Participants
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies
Neutralizing anti-AMG 592 antibodies positive post-baseline with a negative or no result at baseline
|
2 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
|
Phase 1b: Number of Participants With Anti-Efavaleukin Alfa Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies
Neutralizing anti-IL2 antibody positive post-baseline with a negative or no result at baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
ACR 50 and ACR 70 response defined as at least 50 percent or 70 percent improvement from baseline in both tender and swollen joint counts, and a 50 percent or 70 percent improvement or more in at least 3 of the following 5 criteria: * physician global assessment of disease activity (PGA) * subject global assessment of disease activity (SGA) * patient global assessment of joint pain * subject self-assessment of disability (HAQ-DI) * C-Reactive Protein (CRP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Change from baseline in DAS28-ER at Week 12. DAS28-ESR was to assess disease activity in patients with rheumatoid arthritis. DAS28-ESR is a composite score that includes 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score range from 0-10, higher score indicates more disease activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Change from baseline in DAS28-CRP at Week 12. 2. DAS28-CRP was to assess disease activity in patients with rheumatoid arthritis. DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by CRP in mg/L. DAS28-CRP total score range from 0-10, higher score indicates more disease activity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Any changes in systolic/diastolic blood pressure, heart rate, respiratory rate, and temperature that were deemed as clinically significant by the Investigator were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Laboratory safety tests included chemistry and hematology parameters. Clinically significant laboratory safety tests were any events assessed as CTCAE Grade ≥3 at any post-baseline visit. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4 Life-threatening consequences; urgent interventions indicated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
A summary of mean serum concentrations of Efavaleukin alfa over time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (pre-dose) and weeks 2, 4, 6, 8, 10 and 12Population: No data is available for phase 2a. Study was terminated prior to any participants enrolling in phase 2a.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1b: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1b: Efavaleukin Alfa Cohort 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1b: Efavaleukin Alfa Cohort 2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 1b: Efavaleukin Alfa Cohort 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b: Placebo
n=8 participants at risk
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 participants at risk
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 participants at risk
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 participants at risk
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
Other adverse events
| Measure |
Phase 1b: Placebo
n=8 participants at risk
Matching placebo administered via subcutaneous injection for a total of up to 12 weeks. Participants received placebo in 1 of 2 dosing schedules (i.e. dosing schedule A \[less frequent\] or schedule B \[more frequent\]).
|
Phase 1b: Efavaleukin Alfa Cohort 1
n=6 participants at risk
A low dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 2
n=11 participants at risk
A high dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule A (less frequent than schedule B) for a total of up to 12 weeks.
|
Phase 1b: Efavaleukin Alfa Cohort 3
n=11 participants at risk
A medium dose of Efavaleukin alfa administered via subcutaneous injection using dosing schedule B (more frequent than schedule A) for a total of up to 12 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
27.3%
3/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Eye disorders
Cataract
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Administration site reaction
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Chest pain
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Chills
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
66.7%
4/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
27.3%
3/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site pain
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site pruritus
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
54.5%
6/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
72.7%
8/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Injection site swelling
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Pain
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Gingivitis
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Investigations
Blood pressure increased
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Investigations
Body temperature increased
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
27.3%
3/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
16.7%
1/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
36.4%
4/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Nervous system disorders
Dizziness postural
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
33.3%
2/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
9.1%
1/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/6 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
0.00%
0/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
18.2%
2/11 • Day 1 up to end of study, maximum of 18 weeks (12-weeks double-blind treatment, 6-weeks safety follow-up)
All-cause mortality is reported for all participants enrolled/randomized in the study. Treatment emergent serious adverse events and other adverse events, including disease-related events are reported for all participants who received at least one dose of study drug. No data is available for phase 1b Cohort 4 or phase 2a cohorts as the study was terminated prior to any participants enrolling.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER