Crohn's Disease, Inflammatory Bowel Disease
Conditions
Keywords
Crohn's Disease, Crohns, Bowel disease, digestive disorders, auto immune, diarrhea, Inflammatory Bowel Disease (IBD), gastrointestinal diseases, digestive system diseases, Antibody, IL 17, anti IL-17, monoclonal antibody, Crohn's Disease (Chron's, CD)
Brief summary
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
Interventions
DRUGAIN457
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.
Exclusion criteria
* Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician. * Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study * Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | From Start of the Study up to Study Termination (up to 42 Weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-AIN457 Antibodies | From Start of the Study up to Study Termination (up to 42 Weeks) | Anti-AIN457 antibodies were assessed in serum. |
| Change From Baseline in Concentration of Interleukin 17 (IL-17) | Baseline up to Study Termination (up to 42 Weeks) | — |
| Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin | Baseline up to Study Termination (up to 42 Weeks) | — |
| Change From Baseline in C-Reactive Protein Levels | Baseline up to Study Termination (up to 42 Weeks) | — |
| 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) | Pre-dose, post dose on week 44 (end of infusion) | — |
| 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) | Pre-dose, post dose on week 44 (end of infusion) | — |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Secukinumab Participants received 3 milligrams per kilogram (mg/kg) of intravenous (IV) secukinumab once every 4 weeks (q4wk) up to one year of treatment. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative problems | 7 |
Baseline characteristics
| Characteristic | Secukinumab |
|---|---|
| Age, Continuous | 44.9 Years STANDARD_DEVIATION 15.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race/Ethnicity, Customized Caucasian | 7 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 3 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)
Population: Safety analysis set consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Participants With Adverse Events | 3 Participants |
Secondary
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Time frame: Baseline up to Study Termination (up to 42 Weeks)
Population: Safety analysis set consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Change From Baseline in Concentration of Interleukin 17 (IL-17) | NA Participants |
Secondary
Change From Baseline in C-Reactive Protein Levels
Time frame: Baseline up to Study Termination (up to 42 Weeks)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secukinumab | Change From Baseline in C-Reactive Protein Levels | 14.2 milligram per liter (mg/L) | Standard Deviation 20.54 |
Secondary
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Time frame: Baseline up to Study Termination (up to 42 Weeks)
Population: Safety analysis set consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin | NA Participants |
Secondary
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)
Time frame: Pre-dose, post dose on week 44 (end of infusion)
Population: 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.
Secondary
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)
Time frame: Pre-dose, post dose on week 44 (end of infusion)
Population: 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.
Secondary
Number of Participants With Anti-AIN457 Antibodies
Anti-AIN457 antibodies were assessed in serum.
Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)
Population: Safety analysis set consisted of all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Secukinumab | Number of Participants With Anti-AIN457 Antibodies | NA Participants |