Clinical trial NCT01009281: An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Official title: A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Inflammatory Bowel Disease
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)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From Start of the Study up to Study Termination (up to 42 Weeks)
Secondary outcomes:
measure: Number of Participants With Anti-AIN457 Antibodies
timeFrame: From Start of the Study up to Study Termination (up to 42 Weeks)
measure: Change From Baseline in Concentration of Interleukin 17 (IL-17)
timeFrame: Baseline up to Study Termination (up to 42 Weeks)
measure: Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
timeFrame: Baseline up to Study Termination (up to 42 Weeks)
measure: Change From Baseline in C-Reactive Protein Levels
timeFrame: Baseline up to Study Termination (up to 42 Weeks)
measure: 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)
timeFrame: Pre-dose, post dose on week 44 (end of infusion)
measure: 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)
timeFrame: Pre-dose, post dose on week 44 (end of infusion)
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Conneticut Gastroenterology Institute, 39 Brewster Road
state: Connecticut
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: New York
country: United States
facility: Mount Sinai, One Gustave L. Levy Place, Box 1118
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
state: North Carolina
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Hueber W, Sands BE, Lewitzky S, Vandemeulebroecke M, Reinisch W, Higgins PD, Wehkamp J, Feagan BG, Yao MD, Karczewski M, Karczewski J, Pezous N, Bek S, Bruin G, Mellgard B, Berger C, Londei M, Bertolino AP, Tougas G, Travis SP; Secukinumab in Crohn's Disease Study Group. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012 Dec;61(12):1693-700. doi: 10.1136/gutjnl-2011-301668. Epub 2012 May 17.