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Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

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ClinicalTrials.gov Identifier: NCT02547714
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : June 27, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: Secukinumab (AIN457)
Enrollment 34
Recruitment Details  
Pre-assignment Details The overall treatment period consisted of a 4 week induction period (Day 1 and weeks 1, 2, 3 and 4) and a 12 week maintenance period (weeks 8 and 12). All participants entered and completed both periods.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
51.5  (12.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
10
  29.4%
Male
24
  70.6%
1.Primary Outcome
Title Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
Hide Description PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 was defined as participants achieving >= 75% improvement from baseline.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Percentage of participants
82.4
2.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Score
Hide Description PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change from baseline indicates improvement.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: Percent change
-65.64  (37.200)
3.Secondary Outcome
Title Percentage of Participants Achieving PASI 50 or PASI 75
Hide Description

PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Percentage of participants
PASI 50 76.5
PASI 75 44.1
4.Secondary Outcome
Title Percentage of Participants Achieving PASI 90 and Investigator’s Global Assessment (IGA) of 0 or 1 Response
Hide Description

PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).

PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.

Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Percentage of participants
PASI 90 64.7
IGA 0/1 70.6
5.Secondary Outcome
Title Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was considered for the analysis. Only participants who had both baseline and week 16 values were included in the analysis. The full analysis set included all participants who received at least one dose of study drug.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Percent change
-63.07  (59.192)
6.Secondary Outcome
Title Percentage of Participants Achieving DLQI 0 or 1
Hide Description The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
Arm/Group Title Secukinumab (AIN457) 300 mg
Hide Arm/Group Description:
Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Percentage of participants
76.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Entire Period - Secukinumab (AIN457) Induction Period - Secukinumab (AIN457)
Hide Arm/Group Description Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12. During the induction period, participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, and 4.
All-Cause Mortality
Entire Period - Secukinumab (AIN457) Induction Period - Secukinumab (AIN457)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Entire Period - Secukinumab (AIN457) Induction Period - Secukinumab (AIN457)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Entire Period - Secukinumab (AIN457) Induction Period - Secukinumab (AIN457)
Affected / at Risk (%) Affected / at Risk (%)
Total   24/34 (70.59%)   10/34 (29.41%) 
Eye disorders     
Conjunctivitis allergic  1  1/34 (2.94%)  0/34 (0.00%) 
Dry eye  1  1/34 (2.94%)  0/34 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/34 (2.94%)  0/34 (0.00%) 
Gastric polyps  1  1/34 (2.94%)  0/34 (0.00%) 
Gastritis  1  1/34 (2.94%)  0/34 (0.00%) 
Gastrooesophageal reflux disease  1  1/34 (2.94%)  0/34 (0.00%) 
General disorders     
Injection site erythema  1  1/34 (2.94%)  0/34 (0.00%) 
Malaise  1  1/34 (2.94%)  0/34 (0.00%) 
Infections and infestations     
Angular cheilitis  1  1/34 (2.94%)  0/34 (0.00%) 
Gastroenteritis  1  1/34 (2.94%)  0/34 (0.00%) 
Nasopharyngitis  1  7/34 (20.59%)  4/34 (11.76%) 
Paronychia  1  1/34 (2.94%)  0/34 (0.00%) 
Sinusitis  1  1/34 (2.94%)  1/34 (2.94%) 
Tinea versicolour  1  1/34 (2.94%)  0/34 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/34 (2.94%)  0/34 (0.00%) 
Laceration  1  1/34 (2.94%)  0/34 (0.00%) 
Wound  1  1/34 (2.94%)  0/34 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/34 (2.94%)  0/34 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/34 (2.94%)  0/34 (0.00%) 
Oropharyngeal discomfort  1  1/34 (2.94%)  1/34 (2.94%) 
Productive cough  1  1/34 (2.94%)  1/34 (2.94%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/34 (2.94%)  1/34 (2.94%) 
Dermatitis contact  1  2/34 (5.88%)  1/34 (2.94%) 
Eczema  1  1/34 (2.94%)  0/34 (0.00%) 
Pruritus  1  1/34 (2.94%)  1/34 (2.94%) 
Rash  1  2/34 (5.88%)  0/34 (0.00%) 
Vascular disorders     
Hot flush  1  1/34 (2.94%)  0/34 (0.00%) 
Hypertension  1  2/34 (5.88%)  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02547714     History of Changes
Other Study ID Numbers: CAIN457AJP01
First Submitted: July 12, 2015
First Posted: September 11, 2015
Results First Submitted: April 11, 2017
Results First Posted: June 27, 2017
Last Update Posted: September 11, 2017