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A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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ClinicalTrials.gov Identifier: NCT01071252
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Plaque-type Psoriasis
Interventions Drug: AIN457
Drug: Placebo
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Hide Arm/Group Description AIN457 25mg Subcutaneously as a single dose AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Period Title: Overall Study
Started 29 26 21 27 22
Completed 14 16 17 20 11
Not Completed 15 10 4 7 11
Reason Not Completed
unsatisfactory therapeutic effect             4             6             2             0             6
Withdrawal by Subject             8             2             1             2             3
administrative problems             1             1             0             2             1
Lost to Follow-up             1             0             1             2             0
Adverse Event             1             1             0             1             0
Death             0             0             0             0             1
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo Total
Hide Arm/Group Description AIN457 25mg Subcutaneously as a single dose AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) Total of all reporting groups
Overall Number of Baseline Participants 29 26 21 27 22 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 26 participants 21 participants 27 participants 22 participants 125 participants
46.1  (12.65) 46.3  (13.43) 45.8  (12.36) 45.4  (11.64) 45.9  (10.88) 45.9  (12.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 26 participants 21 participants 27 participants 22 participants 125 participants
Female
9
  31.0%
4
  15.4%
7
  33.3%
6
  22.2%
8
  36.4%
34
  27.2%
Male
20
  69.0%
22
  84.6%
14
  66.7%
21
  77.8%
14
  63.6%
91
  72.8%
1.Primary Outcome
Title Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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).
Time Frame week 13
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Hide Arm/Group Description:
AIN457 25mg Subcutaneously as a single dose
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Overall Number of Participants Analyzed 29 26 21 27 22
Measure Type: Number
Unit of Measure: percentage of participants
3.4 19.2 57.1 81.5 9.1
2.Secondary Outcome
Title Percentage of Participants With Investigator's Global Assessment (IGA) Response
Hide Description IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Time Frame Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Hide Arm/Group Description:
AIN457 25mg Subcutaneously as a single dose
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Overall Number of Participants Analyzed 29 26 21 27 22
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 0 0 0 3.7 0
Week 3 0 0 0 3.7 0
Week 5 0 3.8 4.8 7.4 0
Week 9 0 7.7 28.6 37 9.1
Week 13 0 11.5 33.3 48.1 9.1
Week 17 3.4 19.2 28.6 51.9 9.1
Week 21 0 19.2 38.1 40.7 13.6
Week 25 0 15.4 33.3 37 18.2
Week 29 0 11.5 19.0 40.7 13.6
Week 33 0 15.4 19.0 29.6 0
Week 37 0 15.4 9.5 25.9 0
3.Secondary Outcome
Title Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)
Hide Description PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for 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).
Time Frame Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Hide Arm/Group Description:
AIN457 25mg Subcutaneously as a single dose
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Overall Number of Participants Analyzed 29 26 21 27 22
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 2 PASI 50 3.4 7.7 4.8 11.1 0
Week 2 PASI 75 0 0 0 0 0
Week 2 PASI 90 0 0 0 0 0
Week 3 PASI 50 3.4 7.7 23.8 18.5 4.5
Week 3 PASI 75 0 0 0 0 0
Week 3 PASI 90 0 0 0 0 0
Week 5 PASI 50 10.3 15.4 28.6 48.1 4.5
Week 5 PASI 75 0 7.7 4.8 14.8 4.5
Week 5 PASI 90 0 0 0 3.7 0
Week 9 PASI 50 10.3 38.5 52.4 85.2 13.6
Week 9 PASI 75 3.4 11.5 33.3 66.7 9.1
Week 9 PASI 90 0 3.8 9.5 14.8 0
Week 13 PASI 50 17.2 57.7 81.0 85.2 18.2
Week 13 PASI 75 3.4 19.2 57.1 81.5 9.1
Week 13 PASI 90 0 7.7 19.0 51.9 4.5
Week 17 PASI 50 20.7 53.8 76.2 85.2 27.3
Week 17 PASI 75 6.9 26.9 42.9 81.5 13.6
Week 17 PASI 90 0 15.4 9.5 44.4 0
Week 21 PASI 50 13.8 50.0 57.1 85.2 31.8
Week 21 PASI 75 0 23.1 38.1 77.8 13.6
Week 21 PASI 90 0 15.4 9.5 37.0 4.5
Week 25 PASI 50 13.8 50.0 57.1 85.2 31.8
Week 25 PASI 75 0 19.2 33.3 70.4 9.1
Week 25 PASI 90 0 11.5 19.0 29.6 4.5
Week 29 PASI 50 17.2 46.2 52.4 85.2 27.3
Week 29 PASI 75 0 15.4 23.8 59.3 13.6
Week 29 PASI 90 0 7.7 14.3 22.2 9.1
Week 33 PASI 50 10.3 34.6 47.6 77.8 22.7
Week 33 PASI 75 3.4 19.2 23.8 55.6 4.5
Week 33 PASI 90 0 0 9.5 18.5 4.5
Week 37 PASI 50 17.2 30.8 47.6 63.0 22.7
Week 37 PASI 75 3.4 19.2 19.0 25.9 4.5
Week 37 PASI 90 0 3.8 9.5 11.1 4.5
4.Secondary Outcome
Title To Assess the Time to Relapse
Hide Description Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Time Frame 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg
Hide Arm/Group Description:
AIN457 25mg Subcutaneously as a single dose
AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
Overall Number of Participants Analyzed 1 5 12 22
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [2] 
(198 to NA)
203 [2] 
(203 to NA)
[1]
Not Estimable because no relapses occured
[2]
Not Estimable because very low relapses occured
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Hide Arm/Group Description AIN457 25mg Subcutaneously as a single dose AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9) Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
All-Cause Mortality
AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   2/26 (7.69%)   1/21 (4.76%)   0/27 (0.00%)   2/22 (9.09%) 
Cardiac disorders           
Acute myocardial infarction  1  0/29 (0.00%)  0/26 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/22 (4.55%) 
Atrial fibrillation  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  0/27 (0.00%)  0/22 (0.00%) 
Cardiomyopathy  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  0/27 (0.00%)  0/22 (0.00%) 
Myocardial infarction  1  0/29 (0.00%)  0/26 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/22 (4.55%) 
Wolff-Parkinson-White syndrome  1  0/29 (0.00%)  0/26 (0.00%)  1/21 (4.76%)  0/27 (0.00%)  0/22 (0.00%) 
Infections and infestations           
Gastroenteritis viral  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  0/27 (0.00%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders           
Psoriatic arthropathy  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  0/27 (0.00%)  0/22 (0.00%) 
Nervous system disorders           
Transient ischaemic attack  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  0/27 (0.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 1x25mg AIN457 3x25mg AIN457 3x75mg AIN457 3x150mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/29 (48.28%)   11/26 (42.31%)   10/21 (47.62%)   16/27 (59.26%)   8/22 (36.36%) 
General disorders           
Fatigue  1  0/29 (0.00%)  0/26 (0.00%)  0/21 (0.00%)  3/27 (11.11%)  1/22 (4.55%) 
Oedema peripheral  1  0/29 (0.00%)  0/26 (0.00%)  0/21 (0.00%)  2/27 (7.41%)  1/22 (4.55%) 
Infections and infestations           
Nasopharyngitis  1  1/29 (3.45%)  4/26 (15.38%)  4/21 (19.05%)  4/27 (14.81%)  2/22 (9.09%) 
Pharyngitis  1  0/29 (0.00%)  1/26 (3.85%)  0/21 (0.00%)  2/27 (7.41%)  0/22 (0.00%) 
Respiratory tract infection viral  1  1/29 (3.45%)  1/26 (3.85%)  1/21 (4.76%)  0/27 (0.00%)  2/22 (9.09%) 
Upper respiratory tract infection  1  3/29 (10.34%)  2/26 (7.69%)  1/21 (4.76%)  2/27 (7.41%)  0/22 (0.00%) 
Injury, poisoning and procedural complications           
Muscle strain  1  1/29 (3.45%)  0/26 (0.00%)  0/21 (0.00%)  2/27 (7.41%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  0/29 (0.00%)  1/26 (3.85%)  2/21 (9.52%)  1/27 (3.70%)  0/22 (0.00%) 
Myalgia  1  2/29 (6.90%)  0/26 (0.00%)  0/21 (0.00%)  0/27 (0.00%)  1/22 (4.55%) 
Nervous system disorders           
Headache  1  1/29 (3.45%)  2/26 (7.69%)  1/21 (4.76%)  1/27 (3.70%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders           
Pruritus  1  1/29 (3.45%)  0/26 (0.00%)  0/21 (0.00%)  1/27 (3.70%)  3/22 (13.64%) 
Psoriasis  1  8/29 (27.59%)  4/26 (15.38%)  4/21 (19.05%)  3/27 (11.11%)  2/22 (9.09%) 
Vascular disorders           
Hypertension  1  1/29 (3.45%)  1/26 (3.85%)  0/21 (0.00%)  2/27 (7.41%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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: NCT01071252    
Other Study ID Numbers: CAIN457A2220
2009-016807-42
First Submitted: February 18, 2010
First Posted: February 19, 2010
Results First Submitted: January 28, 2015
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015