Trial Outcomes & Findings for Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A (NCT NCT02547714)
NCT ID: NCT02547714
Last Updated: 2017-09-11
Results Overview
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.
COMPLETED
PHASE4
34 participants
Week 16
2017-09-11
Participant Flow
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.
Participant milestones
| Measure |
Secukinumab (AIN457) 300 mg
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 Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
Baseline characteristics by cohort
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)
|
82.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Mean Percent Change From Baseline in PASI Score
|
-65.64 Percent change
Standard Deviation 37.200
|
SECONDARY outcome
Timeframe: Week 4Population: The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving PASI 50 or PASI 75
PASI 50
|
76.5 Percentage of participants
|
|
Percentage of Participants Achieving PASI 50 or PASI 75
PASI 75
|
44.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
PASI 90
|
64.7 Percentage of participants
|
|
Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response
IGA 0/1
|
70.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: 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.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=33 Participants
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.
|
|---|---|
|
Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
|
-63.07 Percent change
Standard Deviation 59.192
|
SECONDARY outcome
Timeframe: Week 16Population: The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.
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.
Outcome measures
| Measure |
Secukinumab (AIN457) 300 mg
n=34 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving DLQI 0 or 1
|
76.5 Percentage of participants
|
Adverse Events
Entire Period - Secukinumab (AIN457)
Induction Period - Secukinumab (AIN457)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Entire Period - Secukinumab (AIN457)
n=34 participants at risk
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.
|
Induction Period - Secukinumab (AIN457)
n=34 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
2.9%
1/34
|
0.00%
0/34
|
|
Eye disorders
Dry eye
|
2.9%
1/34
|
0.00%
0/34
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
1/34
|
0.00%
0/34
|
|
Gastrointestinal disorders
Gastric polyps
|
2.9%
1/34
|
0.00%
0/34
|
|
Gastrointestinal disorders
Gastritis
|
2.9%
1/34
|
0.00%
0/34
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
1/34
|
0.00%
0/34
|
|
General disorders
Injection site erythema
|
2.9%
1/34
|
0.00%
0/34
|
|
General disorders
Malaise
|
2.9%
1/34
|
0.00%
0/34
|
|
Infections and infestations
Angular cheilitis
|
2.9%
1/34
|
0.00%
0/34
|
|
Infections and infestations
Gastroenteritis
|
2.9%
1/34
|
0.00%
0/34
|
|
Infections and infestations
Nasopharyngitis
|
20.6%
7/34
|
11.8%
4/34
|
|
Infections and infestations
Paronychia
|
2.9%
1/34
|
0.00%
0/34
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34
|
2.9%
1/34
|
|
Infections and infestations
Tinea versicolour
|
2.9%
1/34
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
1/34
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Laceration
|
2.9%
1/34
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Wound
|
2.9%
1/34
|
0.00%
0/34
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/34
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
2.9%
1/34
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
1/34
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/34
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
2/34
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.9%
1/34
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
2/34
|
0.00%
0/34
|
|
Vascular disorders
Hot flush
|
2.9%
1/34
|
0.00%
0/34
|
|
Vascular disorders
Hypertension
|
5.9%
2/34
|
2.9%
1/34
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER