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Trial record 85 of 154 for:    Dermatitis, Atopic, 8

Secukinumab for Treatment of Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02594098
Recruitment Status : Completed
First Posted : November 2, 2015
Results First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Emma.Guttman, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Secukinumab
Drug: Placebo
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Secukinumab Extrinsic Placebo Then Secukinumab Extrinsic
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 27 14
Completed 1 1
Not Completed 26 13
Reason Not Completed
Lack of Efficacy             17             6
Withdrawal by Subject             1             3
Terminated participation             6             2
Seek alternative treatment             2             1
Other             0             1
Arm/Group Title Placebo Then Secukinumab Secukinumab Only Total
Hide Arm/Group Description

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 (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 of all reporting groups
Overall Number of Baseline Participants 14 27 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 27 participants 41 participants
33.9  (15.9) 38.3  (13.8) 36.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 27 participants 41 participants
Female
6
  42.9%
12
  44.4%
18
  43.9%
Male
8
  57.1%
15
  55.6%
23
  56.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 27 participants 41 participants
Hispanic or Latino
0
   0.0%
3
  11.1%
3
   7.3%
Not Hispanic or Latino
14
 100.0%
24
  88.9%
38
  92.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 27 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  42.9%
10
  37.0%
16
  39.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  14.3%
2
   7.4%
4
   9.8%
White
6
  42.9%
14
  51.9%
20
  48.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.7%
1
   2.4%
Eczema Area and Severity Index (EASI) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 27 participants 41 participants
29.9  (12.6) 29.0  (12.0) 29.3  (12.04)
[1]
Measure Description: 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.
SCORing Atopic Dermatitis (SCORAD) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 27 participants 41 participants
63.3  (14.1) 65.0  (12.7) 64.4  (13.0)
[1]
Measure Description: SCORing Atopic Dermatitis -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.
IgE level   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 14 participants 27 participants 41 participants
3424  (3509) 5101  (11157) 4555.8  (9348.9)
[1]
Measure Description: Intrinsic Atopic Dermatitis IgE =< 500 kU/L; Extrinsic Atopic Dermatitis, IgE > 500 kU/L
1.Primary Outcome
Title Fold-Change in Epidermal Thickness of Lesional Skin
Hide Description Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data only for those that returned for week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
1.15  (1.22) 1.5  (1.3) 1.18  (1.15) -1  (1.15)
2.Secondary Outcome
Title Fold-Change in K16 Expression of Lesional Skin
Hide Description Epidermal 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
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
1.14  (1.89) -3.96  (2.33) 1.36  (1.56) -1.3  (1.84)
3.Secondary Outcome
Title Number of Patients With SCORAD-50
Hide Description 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.
Time Frame Week 4, Week 16, Week 32, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
data for participants who returned for the respective week visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 8 5 17 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 8 participants 5 participants 17 participants 10 participants
0
   0.0%
0
   0.0%
2
  11.8%
0
   0.0%
Week 16 Number Analyzed 7 participants 3 participants 14 participants 8 participants
0
   0.0%
0
   0.0%
3
  21.4%
2
  25.0%
Week 32 Number Analyzed 1 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
Week 52 Number Analyzed 1 participants 0 participants 0 participants 1 participants
1
 100.0%
0 0
1
 100.0%
4.Secondary Outcome
Title Number of Patients Who Achieve EASI-50 Score
Hide Description 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.
Time Frame Week 4, Week 16, Week 32, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
data for participants who returned for the respective week visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 8 5 17 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4 Number Analyzed 8 participants 5 participants 17 participants 10 participants
0
   0.0%
0
   0.0%
1
   5.9%
0
   0.0%
Week 16 Number Analyzed 7 participants 3 participants 14 participants 8 participants
0
   0.0%
1
  33.3%
3
  21.4%
4
  50.0%
Week 32 Number Analyzed 1 participants 2 participants 1 participants 2 participants
0
   0.0%
2
 100.0%
0
   0.0%
1
  50.0%
Week 52 Number Analyzed 1 participants 0 participants 0 participants 1 participants
1
 100.0%
0 0
1
 100.0%
5.Secondary Outcome
Title Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Hide Description 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).
Time Frame Week 16, Week 32, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
data for participants who returned for the respective week visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 8 5 17 10
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16 Number Analyzed 7 participants 3 participants 14 participants 8 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
Week 32 Number Analyzed 1 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 52 Number Analyzed 1 participants 0 participants 0 participants 1 participants
0
   0.0%
0 0
0
   0.0%
6.Secondary Outcome
Title Percentage Change From Baseline in SCORAD Score
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
data for participants who returned for the week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: percentage change
-3.19  (9.92) -27.31  (7.48) -8.54  (6.22) -6.11  (13.85)
7.Secondary Outcome
Title Percentage Change From Baseline in EASI Scores
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: percentage change
5.27  (12.71) -28.74  (15.01) -4.96  (7.54) -16.9  (18.92)
8.Secondary Outcome
Title Fold-Change in Elafin/Pi3 Level From Baseline
Hide Description 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
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
-1.00  (2.06) -7.90  (2.60) 1.3  (1.66) -2.65  (2.00)
9.Secondary Outcome
Title Fold-Change in CCL20 Level
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
1.35  (1.76) -1.38  (2.10) 1.23  (1.48) -1.85  (1.72)
10.Secondary Outcome
Title Fold-Change in CXCL1 Level
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
1.12  (1.71) -2.72  (2.02) 1.31  (1.45) -1.38  (1.67)
11.Secondary Outcome
Title Fold-Change in S100A7 Level
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
-1.13  (1.83) -5.25  (2.24) 1.43  (1.52) -2.59  (1.79)
12.Secondary Outcome
Title Fold-Change in A8 Level
Hide Description 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
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Data analysis only for those who returned for Week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
-1.32  (2.12) -9.51  (2.72) 1.51  (1.69) -2.61  (2.1)
13.Secondary Outcome
Title Fold-Change in A9 Level
Hide Description 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.
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
data only for those who returned for week 16 visit
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
-1.47  (0.86) -20.03  (1.36) 1.58  (0.6) -2.16  (0.85)
14.Secondary Outcome
Title Fold-Change in A12 Level
Hide Description Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline
Time Frame at Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Secukinumab for Extrinsic AD Placebo Then Secukinumab for Intrinsic AD Secukinumab Only for Extrinsic AD Secukinumab Only for Intrinsic AD
Hide Arm/Group Description:

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 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 (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 (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.

Overall Number of Participants Analyzed 7 3 14 8
Mean (Standard Error)
Unit of Measure: fold-change
1.24  (2.24) -15.06  (2.91) 1.95  (1.76) -2.87  (2.17)
Time Frame up to 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Then Secukinumab Secukinumab Only
Hide Arm/Group Description

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 (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.

All-Cause Mortality
Placebo Then Secukinumab Secukinumab Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Then Secukinumab Secukinumab Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Then Secukinumab Secukinumab Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   3/27 (11.11%) 
Infections and infestations     
Orbital Cellulitis  1  0/14 (0.00%)  1/27 (3.70%) 
Upper Respiratory Infection  1  0/14 (0.00%)  1/27 (3.70%) 
Streptococcal Pharyngitis  1  0/14 (0.00%)  1/27 (3.70%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Emma Guttman
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
EMail: emma.guttman@mountsinai.org
Layout table for additonal information
Responsible Party: Emma.Guttman, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02594098     History of Changes
Other Study ID Numbers: GCO 15-1486
CAIN457AUS02T ( Other Identifier: Novartis Pharmaceuticals Corporation )
First Submitted: October 30, 2015
First Posted: November 2, 2015
Results First Submitted: April 18, 2019
Results First Posted: June 12, 2019
Last Update Posted: June 12, 2019