Trial Outcomes & Findings for A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis (NCT NCT00669916)
NCT ID: NCT00669916
Last Updated: 2015-04-10
Results Overview
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.
COMPLETED
PHASE1/PHASE2
36 participants
Baseline, Week 4
2015-04-10
Participant Flow
Participant milestones
| Measure |
AIN457
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
AIN457
n=18 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
n=18 Participants
Placebo was administered intravenously as a single dose.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.7 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
50.9 Years
STANDARD_DEVIATION 12.04 • n=7 Participants
|
50.8 Years
STANDARD_DEVIATION 10.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: All participants
The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease) where a reduction in PASI score from baseline indicates improvement. The percentage change was calculated by subtracting the week 4 values from the baseline values.The percentage change was calculated for each entire treatment group (not for each participant). A positive percentage change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457
n=18 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
n=18 Participants
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score
|
58 Percentage change in PASI mean score
|
4 Percentage change in PASI mean score
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: All participants
The IGA is an instrument which captured and categorized the global assessment of all clinical signs and symptoms of disease. The investigator used all available information for the assessment, including subjective information from the participant and (where available) photographs taken at baseline. The IGA categories were clear, almost clear, mild disease, moderate disease, severe disease and very severe disease. This outcome measure shows the percentage of patients who experienced a category change from baseline. Category changes of 1, 2 or 3 indicate improvement.
Outcome measures
| Measure |
AIN457
n=18 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
n=18 Participants
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Change in IGA score = -1
|
5.6 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Change in IGA score = 0
|
11.1 Percentage of participants
|
77.8 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Change in IGA score = 1
|
33.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Change in IGA score = 2
|
44.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Change in IGA score = 3
|
5.6 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 182Population: The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=16 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
|
0.11 days
Interval 0.08 to 0.17
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=16 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
|
74.5 ug/mL
Standard Deviation 13.1
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: All AIN457A treatment group participants
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=18 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
AUClast
|
1532 day*ug/mL
Standard Deviation 343
|
—
|
|
Pharmacokinetics of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)
AUCinf
|
1629 day*ug/mL
Standard Deviation 361
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=16 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
|
7.31 Liters
Standard Error 1.72
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=16 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)
|
0.18 Liters/day
Standard Deviation 0.05
|
—
|
SECONDARY outcome
Timeframe: Day 182Population: All AIN457A treatment group participants
Blood was drawn for PK analyses at baseline (prior to dosing), end of infusion, 1 hr and 2 hr after infusion, and during office visits in Weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 26. The PK samples may have been taken at any time during each office visit, following the day of study drug infusion. This outcome measure shows the mean of all values resulting from each time point outlined above.
Outcome measures
| Measure |
AIN457
n=18 Participants
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)
|
29.2 day
Standard Deviation 6.4
|
—
|
Adverse Events
AIN457A
Placebo
Serious adverse events
| Measure |
AIN457A
n=18 participants at risk
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
n=18 participants at risk
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
5.6%
1/18
|
0.00%
0/18
|
Other adverse events
| Measure |
AIN457A
n=18 participants at risk
AIN457A 3mg/kg was administered intravenously as a single dose.
|
Placebo
n=18 participants at risk
Placebo was administered intravenously as a single dose.
|
|---|---|---|
|
Eye disorders
Corneal degeneration
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18
|
0.00%
0/18
|
|
General disorders
Fatigue
|
11.1%
2/18
|
5.6%
1/18
|
|
General disorders
Oedema peripheral
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Fungal infection
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Influenza
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Injection site infection
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Peritonsillar abscess
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18
|
5.6%
1/18
|
|
Infections and infestations
Tonsillitis
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18
|
5.6%
1/18
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18
|
0.00%
0/18
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18
|
0.00%
0/18
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
1/18
|
0.00%
0/18
|
|
Investigations
Blood cholesterol increased
|
11.1%
2/18
|
0.00%
0/18
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/18
|
5.6%
1/18
|
|
Investigations
Blood glucose increased
|
11.1%
2/18
|
5.6%
1/18
|
|
Investigations
Blood ketone body increased
|
5.6%
1/18
|
0.00%
0/18
|
|
Investigations
Blood triglycerides increased
|
11.1%
2/18
|
11.1%
2/18
|
|
Investigations
Glucose urine present
|
5.6%
1/18
|
0.00%
0/18
|
|
Investigations
Lipase increased
|
0.00%
0/18
|
5.6%
1/18
|
|
Investigations
Protein urine present
|
5.6%
1/18
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.6%
1/18
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.6%
1/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18
|
5.6%
1/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/18
|
5.6%
1/18
|
|
Nervous system disorders
Headache
|
5.6%
1/18
|
5.6%
1/18
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.6%
1/18
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
5.6%
1/18
|
0.00%
0/18
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/18
|
5.6%
1/18
|
|
Vascular disorders
Hypertension
|
11.1%
2/18
|
5.6%
1/18
|
Additional Information
Study Director
Novartis
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