Trial Outcomes & Findings for Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients (NCT NCT01537432)
NCT ID: NCT01537432
Last Updated: 2016-01-05
Results Overview
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
COMPLETED
PHASE2
36 participants
Baseline, Week 12
2016-01-05
Participant Flow
Participant milestones
| Measure |
AIN457 300mg
AIN457 300mg subcutaneously weekly
|
Placebo
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
12
|
|
Overall Study
COMPLETED
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
AIN457 300mg
AIN457 300mg subcutaneously weekly
|
Placebo
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Administrative problems
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
Baseline Characteristics
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Baseline characteristics by cohort
| Measure |
AIN457 300mg
n=24 Participants
AIN457 300mg subcutaneously weekly
|
Placebo
n=12 Participants
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.
Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Outcome measures
| Measure |
AIN457 300mg
n=23 Participants
AIN457 300mg subcutaneously weekly
|
Placebo
n=12 Participants
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12
|
56.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.
Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; - 1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.
Outcome measures
| Measure |
AIN457 300mg
n=24 Participants
AIN457 300mg subcutaneously weekly
|
Placebo
n=12 Participants
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52
|
62.5 percentage of participants
|
33.3 percentage of participants
|
Adverse Events
AIN457 300 mg
Placebo
Serious adverse events
| Measure |
AIN457 300 mg
n=24 participants at risk
AIN457 300mg subcutaneously weekly
|
Placebo
n=12 participants at risk
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Infections and infestations
Lobar pneumonia
|
4.2%
1/24
|
0.00%
0/12
|
Other adverse events
| Measure |
AIN457 300 mg
n=24 participants at risk
AIN457 300mg subcutaneously weekly
|
Placebo
n=12 participants at risk
Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24
|
8.3%
1/12
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/24
|
8.3%
1/12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24
|
8.3%
1/12
|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24
|
8.3%
1/12
|
|
General disorders
Fatigue
|
0.00%
0/24
|
8.3%
1/12
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24
|
8.3%
1/12
|
|
General disorders
Oedema
|
0.00%
0/24
|
8.3%
1/12
|
|
General disorders
Oedema peripheral
|
0.00%
0/24
|
8.3%
1/12
|
|
General disorders
Pyrexia
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Candida infection
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Cellulitis
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Fungal infection
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Nasopharyngitis
|
20.8%
5/24
|
25.0%
3/12
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24
|
8.3%
1/12
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/24
|
8.3%
1/12
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24
|
8.3%
1/12
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24
|
8.3%
1/12
|
|
Investigations
Blood creatinine increased
|
0.00%
0/24
|
8.3%
1/12
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.2%
1/24
|
8.3%
1/12
|
|
Investigations
Weight increased
|
0.00%
0/24
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/24
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/24
|
8.3%
1/12
|
|
Vascular disorders
Hypertension
|
0.00%
0/24
|
8.3%
1/12
|
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