Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01478360
Recruitment Status : Terminated (Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.)
First Posted : November 23, 2011
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: AIN457 (secukinumab)
Drug: Placebo
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description AIN457 10 mg/kg Placebo intravenous injection
Period Title: Overall Study
Started 31 15
PD (Pharmacodynamic) Analysis Set 31 15
PK (Pharmacokinetics) Analysis Set 31 [1] 0
Completed 29 12
Not Completed 2 3
Reason Not Completed
Lost to Follow-up             1             0
Adverse Event             0             1
Administrative problems             1             2
[1]
Serum samples were collected during the study and analyzed only for the AIN457 group
Arm/Group Title AIN457 Placebo Total
Hide Arm/Group Description AIN457 10 mg/kg Placebo intravenous injection Total of all reporting groups
Overall Number of Baseline Participants 31 15 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 15 participants 46 participants
49.8  (11.62) 46.2  (10.40) 48.6  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 15 participants 46 participants
Female
16
  51.6%
7
  46.7%
23
  50.0%
Male
15
  48.4%
8
  53.3%
23
  50.0%
1.Primary Outcome
Title Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
Hide Description The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Time Frame Baseline and 85 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.
Arm/Group Title AIN457 Placebo
Hide Arm/Group Description:
AIN457 10 mg/kg
Placebo intravenous injection
Overall Number of Participants Analyzed 29 13
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Score
-0.173
(-0.425 to 0.079)
-0.007
(-0.380 to 0.365)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AIN457, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5392
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.166
Confidence Interval (2-Sided) 90%
-0.617 to 0.285
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIN457 10 mg/kg Placebo
Hide Arm/Group Description AIN457 10 mg/kg Placebo
All-Cause Mortality
AIN457 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
AIN457 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/31 (3.23%)   2/15 (13.33%) 
Injury, poisoning and procedural complications     
WRIST FRACTURE  1  1/31 (3.23%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
INTERVERTEBRAL DISC PROTRUSION  1  0/31 (0.00%)  1/15 (6.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  0/31 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIN457 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/31 (67.74%)   13/15 (86.67%) 
Ear and labyrinth disorders     
TINNITUS  1  0/31 (0.00%)  1/15 (6.67%) 
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER  1  0/31 (0.00%)  1/15 (6.67%) 
ABDOMINAL RIGIDITY  1  0/31 (0.00%)  1/15 (6.67%) 
CONSTIPATION  1  0/31 (0.00%)  1/15 (6.67%) 
DIARRHOEA  1  0/31 (0.00%)  2/15 (13.33%) 
NAUSEA  1  2/31 (6.45%)  4/15 (26.67%) 
VOMITING  1  1/31 (3.23%)  3/15 (20.00%) 
General disorders     
CHILLS  1  1/31 (3.23%)  1/15 (6.67%) 
FATIGUE  1  1/31 (3.23%)  1/15 (6.67%) 
FEELING COLD  1  0/31 (0.00%)  1/15 (6.67%) 
VESSEL PUNCTURE SITE BRUISE  1  0/31 (0.00%)  1/15 (6.67%) 
Infections and infestations     
CYSTITIS  1  2/31 (6.45%)  0/15 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  3/31 (9.68%)  2/15 (13.33%) 
NASOPHARYNGITIS  1  11/31 (35.48%)  6/15 (40.00%) 
OTITIS EXTERNA  1  0/31 (0.00%)  1/15 (6.67%) 
RESPIRATORY TRACT INFECTION  1  0/31 (0.00%)  1/15 (6.67%) 
VIRAL INFECTION  1  0/31 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
CONTUSION  1  1/31 (3.23%)  1/15 (6.67%) 
NAIL INJURY  1  0/31 (0.00%)  1/15 (6.67%) 
PERIORBITAL CONTUSION  1  0/31 (0.00%)  1/15 (6.67%) 
Investigations     
BODY TEMPERATURE INCREASED  1  0/31 (0.00%)  1/15 (6.67%) 
WEIGHT INCREASED  1  0/31 (0.00%)  1/15 (6.67%) 
Metabolism and nutrition disorders     
IRON DEFICIENCY  1  0/31 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/31 (6.45%)  0/15 (0.00%) 
MUSCLE SPASMS  1  0/31 (0.00%)  1/15 (6.67%) 
PAIN IN EXTREMITY  1  0/31 (0.00%)  1/15 (6.67%) 
Nervous system disorders     
DIZZINESS  1  1/31 (3.23%)  1/15 (6.67%) 
HEADACHE  1  3/31 (9.68%)  4/15 (26.67%) 
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  7/31 (22.58%)  2/15 (13.33%) 
COUGH  1  0/31 (0.00%)  1/15 (6.67%) 
DYSPNOEA  1  3/31 (9.68%)  1/15 (6.67%) 
HAEMOPTYSIS  1  2/31 (6.45%)  0/15 (0.00%) 
OROPHARYNGEAL PAIN  1  1/31 (3.23%)  1/15 (6.67%) 
RHINORRHOEA  1  0/31 (0.00%)  2/15 (13.33%) 
Skin and subcutaneous tissue disorders     
RASH  1  0/31 (0.00%)  1/15 (6.67%) 
XANTHOMA  1  0/31 (0.00%)  1/15 (6.67%) 
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
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: NCT01478360    
Other Study ID Numbers: CAIN457D2204
First Submitted: November 17, 2011
First Posted: November 23, 2011
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015