We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

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: NCT01009281
Recruitment Status : Terminated
First Posted : November 6, 2009
Results First Posted : July 12, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Crohn's Disease
Inflammatory Bowel Disease
Intervention Drug: AIN457
Enrollment 7
Recruitment Details The study was conducted at 6 centers in 3 countries USA, Canada, Poland between 30-August-2009 (first participant enrolled) to 19-August-2010 (Last participant completed).
Pre-assignment Details A total of 7 participants enrolled in the study. All seven participants were discontinued due to early termination of the core study (CAIN457A2202 [NCT00584740]) due to lack of efficacy.
Arm/Group Title Secukinumab
Hide Arm/Group Description Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Period Title: Overall Study
Started 7
Completed 0
Not Completed 7
Reason Not Completed
Administrative problems             7
Arm/Group Title Secukinumab
Hide Arm/Group Description Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
44.9  (15.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
1
  14.3%
Male
6
  85.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
7
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 7 participants
7
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame From Start of the Study up to Study Termination (up to 42 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
2.Secondary Outcome
Title Number of Participants With Anti-AIN457 Antibodies
Hide Description Anti-AIN457 antibodies were assessed in serum.
Time Frame From Start of the Study up to Study Termination (up to 42 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Due to significant delays in sample processing this analysis was not conducted, hence results are not available.
3.Secondary Outcome
Title Change From Baseline in Concentration of Interleukin 17 (IL-17)
Hide Description [Not Specified]
Time Frame Baseline up to Study Termination (up to 42 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Due to technical issues this analysis could not be conducted and therefore no results are available for inclusion in this report.
4.Secondary Outcome
Title Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Hide Description [Not Specified]
Time Frame Baseline up to Study Termination (up to 42 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1] 
[1]
Results are unavailable as the analysis could not be performed due to early termination and the small number of participants in the study
5.Secondary Outcome
Title Change From Baseline in C-Reactive Protein Levels
Hide Description [Not Specified]
Time Frame Baseline up to Study Termination (up to 42 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all participants who received at least one dose of study drug. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: milligram per liter (mg/L)
14.2  (20.54)
6.Secondary Outcome
Title Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss)
Hide Description [Not Specified]
Time Frame Pre-dose, post dose on week 44 (end of infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss)
Hide Description [Not Specified]
Time Frame Pre-dose, post dose on week 44 (end of infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic data analysis included all participants with evaluable pharmacokinetic data. Due to the early discontinuation of all participants, the full dataset of concentration measurements could not be obtained, analyzed and reported.
Arm/Group Title Secukinumab
Hide Arm/Group Description:
Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Start of the Study up to Study Termination (up to 42 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Secukinumab
Hide Arm/Group Description Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment.
All-Cause Mortality
Secukinumab
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
Secukinumab
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Secukinumab
Affected / at Risk (%)
Total   3/7 (42.86%) 
Gastrointestinal disorders   
Abdominal distension  1  1/7 (14.29%) 
Gastrooesophageal reflux disease  1  1/7 (14.29%) 
Nausea  1  1/7 (14.29%) 
Vomiting  1  1/7 (14.29%) 
General disorders   
Influenza like illness  1  1/7 (14.29%) 
Infections and infestations   
Upper respiratory tract infection  1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  1/7 (14.29%) 
Psychiatric disorders   
Depression  1  1/7 (14.29%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
The study was terminated early as participants were discontinued prematurely due to early termination of the core trial (CAIN457A2202 [NCT00584740]). This decision was based on fulfillment of the futility criterion for lack of efficacy, assessed during a scheduled interim analysis in the core trial. Therefore, only very limited information is available from this extension study (CAIN457A2202E1 [NCT01009281]).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01009281    
Other Study ID Numbers: CAIN457A2202E1
EudraCT number: 2009-011621-14
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: May 13, 2021
Results First Posted: July 12, 2021
Last Update Posted: July 12, 2021