Trial Outcomes & Findings for Secukinumab for Treatment of Atopic Dermatitis (NCT NCT02594098)
NCT ID: NCT02594098
Last Updated: 2019-06-12
Results Overview
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
at Week 16
Results posted on
2019-06-12
Participant Flow
Participant milestones
| Measure |
Secukinumab Extrinsic
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Placebo Then Secukinumab Extrinsic
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
14
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
26
|
13
|
Reasons for withdrawal
| Measure |
Secukinumab Extrinsic
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Placebo Then Secukinumab Extrinsic
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
17
|
6
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Terminated participation
|
6
|
2
|
|
Overall Study
Seek alternative treatment
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Secukinumab for Treatment of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo Then Secukinumab
n=14 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only
n=27 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eczema Area and Severity Index (EASI) score
|
29.9 units on a scale
STANDARD_DEVIATION 12.6 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 12.0 • n=7 Participants
|
29.3 units on a scale
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
SCORing Atopic Dermatitis (SCORAD) score
|
63.3 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
65.0 units on a scale
STANDARD_DEVIATION 12.7 • n=7 Participants
|
64.4 units on a scale
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
IgE level
|
3424 kU/L
STANDARD_DEVIATION 3509 • n=5 Participants
|
5101 kU/L
STANDARD_DEVIATION 11157 • n=7 Participants
|
4555.8 kU/L
STANDARD_DEVIATION 9348.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: at Week 16Population: Data only for those that returned for week 16 visit
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in Epidermal Thickness of Lesional Skin
|
1.15 fold-change
Standard Error 1.22
|
1.5 fold-change
Standard Error 1.3
|
1.18 fold-change
Standard Error 1.15
|
-1 fold-change
Standard Error 1.15
|
SECONDARY outcome
Timeframe: at Week 16Epidermal hyperplasia assessed using change in the epidermal proliferation marker Ki67 at week 16 as compared to baseline. Staining quantification was performed with ImageJ 1.42
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in K16 Expression of Lesional Skin
|
1.14 fold-change
Standard Error 1.89
|
-3.96 fold-change
Standard Error 2.33
|
1.36 fold-change
Standard Error 1.56
|
-1.3 fold-change
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Week 4, Week 16, Week 32, Week 52Population: data for participants who returned for the respective week visit
The proportion of patients who achieve an improvement of 50% or greater from their Baseline objective SCORAD up to week 52. SCORing Atopic Dermatitis (SCORAD) -The intensity part of the SCORAD index consists of six items: erythema, edema⁄papulation, excoriations, lichenification, oozing⁄crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=8 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=5 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=17 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=10 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Number of Patients With SCORAD-50
Week 16
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Patients With SCORAD-50
Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With SCORAD-50
Week 4
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Patients With SCORAD-50
Week 52
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 16, Week 32, Week 52Population: data for participants who returned for the respective week visit
The proportion of patients who achieve an improvement of 50% or greater from their Baseline EASI score up to week 52. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=8 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=5 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=17 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=10 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Number of Patients Who Achieve EASI-50 Score
Week 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients Who Achieve EASI-50 Score
Week 16
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Patients Who Achieve EASI-50 Score
Week 32
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients Who Achieve EASI-50 Score
Week 52
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 16, Week 32, Week 52Population: data for participants who returned for the respective week visit
The proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score at Week 16 as compared to Baseline. The static IGA score represents an overall static evaluation of dermatitis, performed by the investigator at each visit. It utilizes a scale of 6-points; total scale ranging from 0 (clear) to 5 (very severe disease).
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=8 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=5 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=17 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=10 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Week 16
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Week 32
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Week 52
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Week 16Population: data for participants who returned for the week 16 visit
Percentage change in SCORAD scores at Week 16 as compared to baseline. SCORing Atopic Dermatitis (SCORAD) full score is 0-103, with higher score indicating more symptoms.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in SCORAD Score
|
-3.19 percentage change
Standard Error 9.92
|
-27.31 percentage change
Standard Error 7.48
|
-8.54 percentage change
Standard Error 6.22
|
-6.11 percentage change
Standard Error 13.85
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Percentage change in EASI scores at Week 16 as compared to baseline. Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in EASI Scores
|
5.27 percentage change
Standard Error 12.71
|
-28.74 percentage change
Standard Error 15.01
|
-4.96 percentage change
Standard Error 7.54
|
-16.9 percentage change
Standard Error 18.92
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of elafin/Pi3 at week 16 as compared to baseline
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in Elafin/Pi3 Level From Baseline
|
-1.00 fold-change
Standard Error 2.06
|
-7.90 fold-change
Standard Error 2.60
|
1.3 fold-change
Standard Error 1.66
|
-2.65 fold-change
Standard Error 2.00
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CCL20 at week 16 as compared to baseline.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in CCL20 Level
|
1.35 fold-change
Standard Error 1.76
|
-1.38 fold-change
Standard Error 2.10
|
1.23 fold-change
Standard Error 1.48
|
-1.85 fold-change
Standard Error 1.72
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CXCL1 at week 16 as compared to baseline.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in CXCL1 Level
|
1.12 fold-change
Standard Error 1.71
|
-2.72 fold-change
Standard Error 2.02
|
1.31 fold-change
Standard Error 1.45
|
-1.38 fold-change
Standard Error 1.67
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of S100A7 at week 16 as compared to baseline.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in S100A7 Level
|
-1.13 fold-change
Standard Error 1.83
|
-5.25 fold-change
Standard Error 2.24
|
1.43 fold-change
Standard Error 1.52
|
-2.59 fold-change
Standard Error 1.79
|
SECONDARY outcome
Timeframe: at Week 16Population: Data analysis only for those who returned for Week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A8 at week 16 as compared to baseline
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in A8 Level
|
-1.32 fold-change
Standard Error 2.12
|
-9.51 fold-change
Standard Error 2.72
|
1.51 fold-change
Standard Error 1.69
|
-2.61 fold-change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: at Week 16Population: data only for those who returned for week 16 visit
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A9 at Week 16 as compared to baseline.
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in A9 Level
|
-1.47 fold-change
Standard Error 0.86
|
-20.03 fold-change
Standard Error 1.36
|
1.58 fold-change
Standard Error 0.6
|
-2.16 fold-change
Standard Error 0.85
|
SECONDARY outcome
Timeframe: at Week 16Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline
Outcome measures
| Measure |
Placebo Then Secukinumab for Extrinsic AD
n=7 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Placebo Then Secukinumab for Intrinsic AD
n=3 Participants
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only for Extrinsic AD
n=14 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
Secukinumab Only for Intrinsic AD
n=8 Participants
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|---|---|
|
Fold-Change in A12 Level
|
1.24 fold-change
Standard Error 2.24
|
-15.06 fold-change
Standard Error 2.91
|
1.95 fold-change
Standard Error 1.76
|
-2.87 fold-change
Standard Error 2.17
|
Adverse Events
Placebo Then Secukinumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Secukinumab Only
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Then Secukinumab
n=14 participants at risk
Placebo via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received placebo Q4W, while the remaining 5 patients received a higher dosing schedule of placebo Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to placebo Q4W or the higher dosing placebo Q2W received secukinumab 300 mg Q4W from Week 16 to Week 20, followed by every 4 weeks until Week 48 or every 2 weeks through Week 48 for the higher dosing schedule.
|
Secukinumab Only
n=27 participants at risk
Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes at Weeks 0, 1, 2, 3, 4.
Thereafter through Week 16, the first 36 patients assessed at baseline received secukinumab 300 mg Q4W, while the remaining 5 patients received a higher dosing schedule of secukinumab 300 mg Q2W.
Starting at Week 16, all subjects received secukinumab 300 mg. Patients initially randomized to secukinumab 300 mg Q4W or the higher dosing secukinumab 300 mg Q2W continued to receive their respective dosages through Week 48.
|
|---|---|---|
|
Infections and infestations
Orbital Cellulitis
|
0.00%
0/14 • up to 52 weeks
|
3.7%
1/27 • up to 52 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/14 • up to 52 weeks
|
3.7%
1/27 • up to 52 weeks
|
|
Infections and infestations
Streptococcal Pharyngitis
|
0.00%
0/14 • up to 52 weeks
|
3.7%
1/27 • up to 52 weeks
|
Additional Information
Dr. Emma Guttman
Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place