Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis (NCT NCT01756898)
NCT ID: NCT01756898
Last Updated: 2021-02-16
Results Overview
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
370 participants
Primary outcome timeframe
Baseline up to 29 days after initial dose.
Results posted on
2021-02-16
Participant Flow
A total of 370 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 42 clinic sites in the United States of America.
Adult male and female subjects with active atopic dermatitis (AD) were enrolled in this study.
Participant milestones
| Measure |
Placebo
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
93
|
93
|
|
Overall Study
COMPLETED
|
73
|
73
|
76
|
77
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
17
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
4
|
7
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
2
|
2
|
1
|
|
Overall Study
Withdrew Consent
|
5
|
3
|
5
|
6
|
|
Overall Study
Other
|
0
|
2
|
2
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
36.9 years
STANDARD_DEVIATION 14.34 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 14.82 • n=5 Participants
|
39 years
STANDARD_DEVIATION 13.71 • n=4 Participants
|
37.7 years
STANDARD_DEVIATION 14.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
260 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
282 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
235 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
90 participants
n=7 Participants
|
92 participants
n=5 Participants
|
93 participants
n=4 Participants
|
366 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA.
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
|
20 Participants
|
21 Participants
|
19 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA by subgroup.
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Male
|
1 participants
|
3 participants
|
7 participants
|
7 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Female
|
19 participants
|
18 participants
|
12 participants
|
11 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
White
|
13 participants
|
12 participants
|
14 participants
|
13 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Black or African American
|
6 participants
|
6 participants
|
4 participants
|
4 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Other
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline EASI score <15
|
18 participants
|
20 participants
|
18 participants
|
17 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline EASI score ≥15
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline Lichenification severity 0-3
|
15 participants
|
9 participants
|
10 participants
|
8 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline Lichenification severity 4-12
|
5 participants
|
12 participants
|
9 participants
|
10 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline % BSA involved <15%
|
16 participants
|
19 participants
|
16 participants
|
15 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline % BSA involved ≥15%
|
4 participants
|
2 participants
|
3 participants
|
3 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline IGA score = 2
|
9 participants
|
9 participants
|
10 participants
|
8 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline IGA score = 3
|
11 participants
|
12 participants
|
8 participants
|
9 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline IGA score = 4 or 5
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline IGA score = 3, 4, or 5
|
11 participants
|
12 participants
|
9 participants
|
10 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Allergic rhinitis/Asthma absent
|
10 participants
|
10 participants
|
8 participants
|
13 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Allergic rhinitis/Asthma present
|
10 participants
|
11 participants
|
11 participants
|
5 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline Immunoglobulin (IgE) <100 IU/mL
|
14 participants
|
10 participants
|
13 participants
|
11 participants
|
|
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Baseline Immunoglobulin (IgE) ≥100 IU/mL
|
6 participants
|
10 participants
|
6 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess EASI.
The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Baseline
|
12.6 Units on a scale
Standard Deviation 11.2
|
12.2 Units on a scale
Standard Deviation 9.67
|
11.2 Units on a scale
Standard Deviation 9.12
|
11.7 Units on a scale
Standard Deviation 9.96
|
|
Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Day 29
|
-3.43 Units on a scale
Standard Deviation 7.96
|
-3.24 Units on a scale
Standard Deviation 7.45
|
-3.51 Units on a scale
Standard Deviation 6.75
|
-2.75 Units on a scale
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the percent Body Surface Area.
Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Baseline
|
21.0 Percentage of BSA
Standard Deviation 20.87
|
19.6 Percentage of BSA
Standard Deviation 21.96
|
18.5 Percentage of BSA
Standard Deviation 19.00
|
18.1 Percentage of BSA
Standard Deviation 17.29
|
|
Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Day 29
|
-3.59 Percentage of BSA
Standard Deviation 7.69
|
-2.99 Percentage of BSA
Standard Deviation 9.44
|
-2.95 Percentage of BSA
Standard Deviation 6.23
|
-3.27 Percentage of BSA
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess pruritus score.
Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Baseline
|
2.3 Units on a scale
Standard Deviation 0.74
|
2.4 Units on a scale
Standard Deviation 0.68
|
2.2 Units on a scale
Standard Deviation 0.72
|
2.5 Units on a scale
Standard Deviation 0.64
|
|
Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Day 29
|
-0.75 Units on a scale
Standard Deviation 1.00
|
-0.80 Units on a scale
Standard Deviation 0.97
|
-0.72 Units on a scale
Standard Deviation 1.03
|
-0.76 Units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline up to 29 days after initial dose.Population: The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the insomnia score.
Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Outcome measures
| Measure |
Placebo
n=91 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=90 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Baseline
|
4.0 Units on a scale
Standard Deviation 3.13
|
3.9 Units on a scale
Standard Deviation 3.09
|
3.7 Units on a scale
Standard Deviation 3.30
|
3.6 Units on a scale
Standard Deviation 2.76
|
|
Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Day 29
|
-1.10 Units on a scale
Standard Deviation 2.69
|
-1.06 Units on a scale
Standard Deviation 2.76
|
-1.20 Units on a scale
Standard Deviation 3.02
|
-0.97 Units on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.Population: The Pharmacokinetic (PK) sample analyses were performed on the PK Population. Only plasma samples from active participants were analyzed for ASB17061 and ASB17584 concentrations.
Outcome measures
| Measure |
Placebo
n=92 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
5 to 10 hours ASB17061
|
8.03 ng/ML
Standard Deviation 9.15
|
18.0 ng/ML
Standard Deviation 20.6
|
38.8 ng/ML
Standard Deviation 55.2
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Day 29 (24-32 hours) ASB17061
|
3.07 ng/ML
Standard Deviation 6.30
|
5.32 ng/ML
Standard Deviation 15.2
|
3.35 ng/ML
Standard Deviation 8.27
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Predose ASB17061
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
0 to 2.5 hours ASB17061
|
24.4 ng/ML
Standard Deviation 18.7
|
48.3 ng/ML
Standard Deviation 51.4
|
89.6 ng/ML
Standard Deviation 78.6
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
2.5 to 5 hours ASB17061
|
18.3 ng/ML
Standard Deviation 13.7
|
33.3 ng/ML
Standard Deviation 24.9
|
72.7 ng/ML
Standard Deviation 48.2
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Predose ASB17584
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
NA ng/ML
Standard Deviation NA
Not Detected (less than 0.5 ng/mL)
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
0 to 2.5 hours ASB17584
|
9.21 ng/ML
Standard Deviation 7.63
|
18.1 ng/ML
Standard Deviation 17.1
|
27.3 ng/ML
Standard Deviation 25.2
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
2.5 to 5 hours ASB17584
|
7.50 ng/ML
Standard Deviation 5.60
|
14.4 ng/ML
Standard Deviation 13.0
|
30.7 ng/ML
Standard Deviation 21.3
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
5 to 10 hours ASB17584
|
2.98 ng/ML
Standard Deviation 3.67
|
6.29 ng/ML
Standard Deviation 6.16
|
15.1 ng/ML
Standard Deviation 20.5
|
—
|
|
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Day 29 (24-32 hours) ASB17584
|
2.40 ng/ML
Standard Deviation 4.21
|
2.31 ng/ML
Standard Deviation 3.11
|
2.11 ng/ML
Standard Deviation 4.24
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.Population: The Cmin was assessed in the Efficacy Evaluable (EE) Population.
The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=72 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=82 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Cmin ASB17061
|
0.88 ng/ML
Standard Deviation 2.09
|
1.34 ng/ML
Standard Deviation 0.94
|
2.43 ng/ML
Standard Deviation 2.44
|
—
|
|
Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Cmin ASB17584
|
0.58 ng/ML
Standard Deviation 0.76
|
0.97 ng/ML
Standard Deviation 0.69
|
1.82 ng/ML
Standard Deviation 1.58
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.Population: The Cmax was assessed in the Efficacy Evaluable (EE)Population.
Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=72 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=82 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Cmax ASB17584
|
11.27 ng/ML
Standard Deviation 4.24
|
22.25 ng/ML
Standard Deviation 8.79
|
42.73 ng/ML
Standard Deviation 15.36
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Cmax ASB17061
|
33.82 ng/ML
Standard Deviation 13.67
|
67.60 ng/ML
Standard Deviation 19.39
|
134.90 ng/ML
Standard Deviation 53.94
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).Population: The Cavg was analyzed in the Efficacy Evaluable Population.
The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=72 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=82 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Cavg ASB17061
|
5.59 ng/ML
Standard Deviation 3.57
|
11.04 ng/ML
Standard Deviation 4.21
|
21.88 ng/ML
Standard Deviation 10.30
|
—
|
|
Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Cavg ASB17584
|
2.16 ng/ML
Standard Deviation 1.21
|
4.18 ng/ML
Standard Deviation 2.04
|
8.30 ng/ML
Standard Deviation 3.84
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 57 follow-up visit post dose.Population: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Population.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
Outcome measures
| Measure |
Placebo
n=92 Participants
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=92 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 Participants
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Bronchitis
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Influenza
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Abdominal pain upper
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Constipation
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Diarrhea
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Dyspepsia
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Flatulence
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Nausea
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Vomiting
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Dermatitis atopic
|
3 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Dermatitis contact
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Eczema
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Pruritis
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Aspartate aminotransferase increased
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Oropharyngeal pain
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Myalgia
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Polyuria
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Hypertension
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Headache
|
4 Participants
|
9 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Nasopharyngitis
|
4 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Sinusitis
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Upper respiratory tract infection
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Urinary tract infection
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Abdominal pain
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Urticaria
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Somnolence
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Blood creatine phosphokinase increased
|
6 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Blood testosterone decreased
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Hepatic enzyme increased
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
White blood cell count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Cough
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Rhinorrhea
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Fatigue
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Arthropod bite
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Ligament sprain
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Insomnia
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Ovarian cyst
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
ASB17061 5 mg Low Dose
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
ASB17061 10 mg Middle Dose
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
ASB17061 20 mg High Dose
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=92 participants at risk
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=92 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=93 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Bilateral Clubfoot
|
0.00%
0/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
1.1%
1/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
0.00%
0/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
0.00%
0/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
Other adverse events
| Measure |
Placebo
n=92 participants at risk
Participants with atopic dermatitis were randomized to receive a placebo.
|
ASB17061 5 mg Low Dose
n=92 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg).
|
ASB17061 10 mg Middle Dose
n=93 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg).
|
ASB17061 20 mg High Dose
n=93 participants at risk
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg).
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
14.1%
13/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
27.2%
25/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
25.8%
24/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
18.3%
17/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
10/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
16.3%
15/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
17.2%
16/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
10.8%
10/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
8.7%
8/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
12.0%
11/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
10.8%
10/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
7.5%
7/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Nervous system disorders
Headache
|
6.5%
6/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
9.8%
9/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
10.8%
10/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
9.7%
9/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.1%
13/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
1.1%
1/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
7.5%
7/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
8.6%
8/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
4.3%
4/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
8.7%
8/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
5.4%
5/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
5.4%
5/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
5.4%
5/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
4.3%
4/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
2.2%
2/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
7.5%
7/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
General disorders
General disorders and administration site conditions
|
5.4%
5/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
3.3%
3/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
3.2%
3/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
2.2%
2/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
1.1%
1/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
1.1%
1/92 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
5.4%
5/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
2.2%
2/93 • Baseline up to 12 weeks after the initial dose.
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place