An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
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
2 other identifiers
interventional
7
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2009
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2010
CompletedResults Posted
Study results publicly available
July 12, 2021
CompletedJuly 12, 2021
June 1, 2021
10 months
November 5, 2009
May 13, 2021
June 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
From Start of the Study up to Study Termination (up to 42 Weeks)
Secondary Outcomes (6)
Number of Participants With Anti-AIN457 Antibodies
From Start of the Study up to Study Termination (up to 42 Weeks)
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)
- +1 more secondary outcomes
Study Arms (1)
AIN457
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Conneticut Gastroenterology Institute, 39 Brewster Road
Bristol, Connecticut, 06010, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Mount Sinai, One Gustave L. Levy Place, Box 1118
New York, New York, 10029, United States
UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
Chapel Hill, North Carolina, 27599-7032, United States
Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
Raleigh, North Carolina, 27612, United States
Related Publications (1)
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.
PMID: 22595313DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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 \[NCT01009281\]).
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
October 30, 2009
Primary Completion
August 19, 2010
Study Completion
August 19, 2010
Last Updated
July 12, 2021
Results First Posted
July 12, 2021
Record last verified: 2021-06