A Phase 2 interventional study of AIN457 in Crohn's Disease and Inflammatory Bowel Disease, sponsored by Novartis Pharmaceuticals. Terminated at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 7 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: AIN457
Number of Participants With Adverse Events
Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)
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)
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Time frame: Baseline up to Study Termination (up to 42 Weeks)
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Time frame: Baseline up to Study Termination (up to 42 Weeks)
Change From Baseline in C-Reactive Protein Levels
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose, post dose on week 44 (end of infusion)
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).
| Milestone | Secukinumab |
|---|---|
| Started | 7 |
| Completed | 0 |
| Not completed | 7 |
| Withdrew: Administrative problems | 7 |
| Participants | Secukinumab |
|---|---|
| Number of Participants With Adverse Events | 3 |
Anti-AIN457 antibodies were assessed in serum.
| Participants | Secukinumab |
|---|---|
| Number of Participants With Anti-AIN457 Antibodies | NA |
| Participants | Secukinumab |
|---|---|
| Change From Baseline in Concentration of Interleukin 17 (IL-17) | NA |
| Participants | Secukinumab |
|---|---|
| Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin | NA |
| milligram per liter (mg/L) | Secukinumab |
|---|---|
| Change From Baseline in C-Reactive Protein Levels | 14.2 ± 20.54 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over From Start of the Study up to Study Termination (up to 42 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| Event | Secukinumab |
|---|---|
| Abdominal distensionGastrointestinal disorders | 1/7 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/7 |
| NauseaGastrointestinal disorders | 1/7 |
| VomitingGastrointestinal disorders | 1/7 |
| Influenza like illnessGeneral disorders | 1/7 |
| Upper respiratory tract infectionInfections and infestations | 1/7 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/7 |
| DepressionPsychiatric disorders | 1/7 |
Safety analysis set consisted of all participants who received at least one dose of study drug.
| Age, Continuous(Years) | Secukinumab |
|---|---|
| Mean | 44.9 ± 15.79 |
| Sex: Female, Male(Participants) | Secukinumab |
|---|---|
| Female | 1 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Secukinumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 7 |
| Race/Ethnicity, Customized(Participants) | Secukinumab |
|---|---|
| Caucasian | 7 |
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals