Crohn's DiseasePhase 2NCT01009281

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

A Phase 2 study testing AIN457 in people with Crohn's Disease and Inflammatory Bowel Disease, run by Novartis Pharmaceuticals at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crohn's Disease, Inflammatory Bowel Disease
What is being tested?: AIN457
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 5 sitesUnited States
Study dates: 30 Oct 2009to 19 Aug 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Conneticut Gastroenterology Institute, 39 Brewster Road
Bristol, Connecticut, 06010
UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
Chapel Hill, North Carolina, 27599-7032
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021
Mount Sinai, One Gustave L. Levy Place, Box 1118
New York, New York, 10029
Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
Raleigh, North Carolina, 27612

Other trials in United States

About this study

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

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.

Conditions: Crohn's Disease, Inflammatory Bowel Disease
Being tested: AIN457
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)
Medical subject headings: Crohn Disease, Inflammatory Bowel Diseases, Intestinal Diseases, Digestive System Diseases, Diarrhea, Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIN457Drug

Study groups in NCT01009281
Study group	Role	What they receive
AIN457	Experimental	Not described Receives: Drug: AIN457

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Measured: From Start of the Study up to Study Termination (up to 42 Weeks)

Secondary outcomes (6)

Number of Participants With Anti-AIN457 Antibodies
Anti-AIN457 antibodies were assessed in serum.
Measured: From Start of the Study up to Study Termination (up to 42 Weeks)
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Measured: Baseline up to Study Termination (up to 42 Weeks)
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Measured: Baseline up to Study Termination (up to 42 Weeks)
Change From Baseline in C-Reactive Protein Levels
Measured: 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)
Measured: 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)
Measured: Pre-dose, post dose on week 44 (end of infusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 200919 Aug 2010

First posted6 Nov 2009 (estimated)
Study start30 Oct 2009
Primary completion19 Aug 2010
Study completion19 Aug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01009281
Sponsor's protocol ID: CAIN457A2202E1
Other IDs: EudraCT number: 2009-011621-14
Status last verified: Jun 2021
First submitted: 5 Nov 2009
Last updated: 12 Jul 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 22595313

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01009281
Acronym / sponsor ID: CAIN457A2202E1
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
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 7 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 30 Oct 2009 (actual)
Primary completion: 19 Aug 2010 (actual)
Study completion: 19 Aug 2010 (actual)
First posted: 6 Nov 2009 (estimated)
Results: Posted 12 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AIN457	Experimental	Drug: AIN457

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIN457	Drug	AIN457

Primary outcome

Number of Participants With Adverse Events
Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)

6 secondary outcomes

Number of Participants With Anti-AIN457 Antibodies
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)

Results and safety

Results posted to the registry on 12 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Secukinumab	7	0

Primary outcome: Number of Participants With Adverse Events

Time frame: From Start of the Study up to Study Termination (up to 42 Weeks). Count of participants. Unit: Participants

Measure	Secukinumab n = 7
Value	3

Population analysed: Safety analysis set consisted of all participants who received at least one dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Start of the Study up to Study Termination (up to 42 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Secukinumab	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7

Limitations and caveats (from the sponsor): 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 \[NCT01009281\]).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22595313Hueber 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.
Related InfoLink provided by the sponsor.

Related trials for Crohn's Disease

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 in people with Crohn's Disease and Inflammatory Bowel Disease, run by Novartis Pharmaceuticals at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: From Start of the Study up to Study Termination (up to 42 Weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.