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Crohn's DiseasePhase 2NCT00584740

Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

A Phase 2 study testing AIN457 in people with Crohn's Disease, run by Novartis Pharmaceuticals at 2 sites in Germany.

Terminated

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

Official record
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Trial summary

This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
AIN457
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
2 sitesGermany
Study dates
Aug 2008to 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

  • Male or female; 18-75 years old
  • Diagnosis of Crohn's disease for at least 3 months prior to screening
  • Confirmation of Crohn's disease by endoscopic or imaging examination
  • Moderately active Crohn's disease at baseline, defined as:
  • CDAI ≥220 and ≤450
  • Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);

Who cannot join

  • Body Mass Index >34
  • Positive PPD tuberculin skin test or QuantiFeron test
  • Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
  • Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
  • Fistulizing disease if complicated by sepsis and/or untreated abscess
  • Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
Show all 9Show fewer
  • Use of certain medications as specified in the protocol
  • Clinical improvement due to other Crohn's therapy
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Stuttgart, 70376

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease

This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.

Conditions
Crohn's Disease
Being tested
AIN457, Placebo
Keywords
Crohn's disease, moderate, severe, active, AIN457
Medical subject headings
Crohn Disease, Lymphoma, Follicular, Motor Activity

What participants receive

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

  • AIN457Drug

    10 mg/kg

  • PlaceboDrug

    Matching placebo to AIN457

Study groups in NCT00584740
Study groupRoleWhat they receive
AIN457ExperimentalAIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Receives: Drug: AIN457
PlaceboPlacebo comparatorMatching placebo to AIN457 was given as an infusion at day 1 and day 22.
Receives: Drug: Placebo

What is being measured

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

  1. Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score

    The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.

    Measured: 6 weeks

Secondary outcomes (6)

  1. Percentage of Participants Achieving Remission and/or Response

    Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.

    Measured: 6 weeks

  2. Percentage of Participants Achieving Remission

    Remission was defined as CDAI < 150 points.

    Measured: 6 weeks

  3. Percentage of Participants Achieving Response

    Response was defined as CDAI reduction of at least 70 points from baseline.

    Measured: 6 weeks

  4. Mean Change From Baseline in CDAI Score

    The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.

    Measured: baseline, 2 weeks, 4 weeks

  5. Area Under CDAI Curve

    The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.

    Measured: 10 weeks

  6. Percentage of Participants Maintaining Remission

    Remission was defined as CDAI < 150 points.

    Measured: 10 weeks

Timeline

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

  1. First posted2 Jan 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2010
  4. Study completionAug 2010

Why it stopped: The study was terminated prematurely after futility criterion was met at planned interim analysis of 41 patients.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00584740
Sponsor's protocol ID
CAIN457A2202
Status last verified
Mar 2015
First submitted
21 Dec 2007
Last updated
31 Mar 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AIN457 in people with Crohn's Disease, run by Novartis Pharmaceuticals at 2 sites in Germany.

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 6 inclusion and 9 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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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 31 Mar 2015). 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?

Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score (time frame: 6 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 NCT00584740.

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 31 Mar 2015.

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