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Trial record 13 of 762 for:    plaque | "Psoriasis"

A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00669916
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Basic Science
Condition Plaque Psoriasis
Interventions Biological: AIN457
Drug: Placebo
Enrollment 36

Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description AIN457A 3mg/kg was administered intravenously as a single dose. Placebo was administered intravenously as a single dose.
Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title AIN457 Placebo Total
Hide Arm/Group Description AIN457A 3mg/kg was administered intravenously as a single dose. Placebo was administered intravenously as a single dose. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
50.7  (8.73) 50.9  (12.04) 50.8  (10.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
11
  61.1%
13
  72.2%
24
  66.7%
Male
7
  38.9%
5
  27.8%
12
  33.3%
1.Primary Outcome
Title Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Mean Score
Hide Description 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.
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Placebo was administered intravenously as a single dose.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: Percentage change in PASI mean score
58 4
2.Primary Outcome
Title Percentage of Participants With Change From Baseline in Investigators Global Assessment (IGA) Score
Hide Description 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.
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Placebo was administered intravenously as a single dose.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: Percentage of participants
Change in IGA score = -1 5.6 11.1
Change in IGA score = 0 11.1 77.8
Change in IGA score = 1 33.3 11.1
Change in IGA score = 2 44.4 0
Change in IGA score = 3 5.6 0
3.Secondary Outcome
Title Pharmacokinetics of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population included all AIN457 treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: days
0.11
(0.08 to 0.17)
4.Secondary Outcome
Title Pharmacokinetics of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: ug/mL
74.5  (13.1)
5.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All AIN457A treatment group participants
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: day*ug/mL
AUClast 1532  (343)
AUCinf 1629  (361)
6.Secondary Outcome
Title Pharmacokinetics of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 16
Mean (Standard Error)
Unit of Measure: Liters
7.31  (1.72)
7.Secondary Outcome
Title Pharmacokinetics of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population included all AIN457A treatment group participants except for two participants who had a nontypical PK profile for Tmax, Cmax, CI and Vz.
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Liters/day
0.18  (0.05)
8.Secondary Outcome
Title Pharmacokinetics of AIN457: Terminal Elimination Half-life (T1/2)
Hide Description 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.
Time Frame Day 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All AIN457A treatment group participants
Arm/Group Title AIN457
Hide Arm/Group Description:
AIN457A 3mg/kg was administered intravenously as a single dose.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: day
29.2  (6.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457A Placebo
Hide Arm/Group Description AIN457A 3mg/kg was administered intravenously as a single dose. Placebo was administered intravenously as a single dose.
All-Cause Mortality
AIN457A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AIN457A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   0/18 (0.00%) 
Cardiac disorders     
Cardiac failure congestive  1  1/18 (5.56%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/18 (50.00%)   8/18 (44.44%) 
Eye disorders     
Corneal degeneration  1  0/18 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Abdominal distension  1  0/18 (0.00%)  1/18 (5.56%) 
Nausea  1  1/18 (5.56%)  0/18 (0.00%) 
General disorders     
Fatigue  1  2/18 (11.11%)  1/18 (5.56%) 
Oedema peripheral  1  1/18 (5.56%)  0/18 (0.00%) 
Infections and infestations     
Fungal infection  1  1/18 (5.56%)  0/18 (0.00%) 
Gastroenteritis viral  1  0/18 (0.00%)  1/18 (5.56%) 
Influenza  1  1/18 (5.56%)  0/18 (0.00%) 
Injection site infection  1  1/18 (5.56%)  0/18 (0.00%) 
Peritonsillar abscess  1  1/18 (5.56%)  0/18 (0.00%) 
Pneumonia  1  0/18 (0.00%)  1/18 (5.56%) 
Sinusitis  1  1/18 (5.56%)  1/18 (5.56%) 
Tonsillitis  1  1/18 (5.56%)  0/18 (0.00%) 
Upper respiratory tract infection  1  0/18 (0.00%)  1/18 (5.56%) 
Investigations     
Alanine aminotransferase increased  1  1/18 (5.56%)  0/18 (0.00%) 
Aspartate aminotransferase increased  1  1/18 (5.56%)  0/18 (0.00%) 
Blood alkaline phosphatase increased  1  1/18 (5.56%)  0/18 (0.00%) 
Blood cholesterol increased  1  2/18 (11.11%)  0/18 (0.00%) 
Blood creatine phosphokinase increased  1  0/18 (0.00%)  1/18 (5.56%) 
Blood glucose increased  1  2/18 (11.11%)  1/18 (5.56%) 
Blood ketone body increased  1  1/18 (5.56%)  0/18 (0.00%) 
Blood triglycerides increased  1  2/18 (11.11%)  2/18 (11.11%) 
Glucose urine present  1  1/18 (5.56%)  0/18 (0.00%) 
Lipase increased  1  0/18 (0.00%)  1/18 (5.56%) 
Protein urine present  1  1/18 (5.56%)  1/18 (5.56%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  1/18 (5.56%)  0/18 (0.00%) 
Hyperlipidaemia  1  1/18 (5.56%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Neck pain  1  0/18 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid neoplasm  1  0/18 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Headache  1  1/18 (5.56%)  1/18 (5.56%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/18 (5.56%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/18 (5.56%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/18 (5.56%)  0/18 (0.00%) 
Pruritus  1  1/18 (5.56%)  0/18 (0.00%) 
Rash  1  1/18 (5.56%)  0/18 (0.00%) 
Skin exfoliation  1  1/18 (5.56%)  0/18 (0.00%) 
Skin fissures  1  1/18 (5.56%)  0/18 (0.00%) 
Skin maceration  1  1/18 (5.56%)  0/18 (0.00%) 
Surgical and medical procedures     
Cataract operation  1  0/18 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hypertension  1  2/18 (11.11%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: Study Director
Organization: Novartis
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00669916     History of Changes
Other Study ID Numbers: CAIN457A2102
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: January 28, 2015
Results First Posted: April 10, 2015
Last Update Posted: April 10, 2015