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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00584740
First received: December 21, 2007
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Drug: AIN457
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Crohn's Disease Activity Index (CDAI) [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - % of subjects achieving remission and/or response (CDAI <150) or a decrease of at least 70 points from baseline - Mean CDAI at 2 and 4 weeks - Maintenance of remission and/or response - Safety/tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AIN457
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584740

Locations
United States, Connecticut
Novartis Investigator Site
Bristol, Connecticut, United States, 06010
United States, Maryland
Novartis Investigator Site
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02114
Novartis Investigator Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigator Site
Ann Arbor, Michigan, United States, 44118
United States, Minnesota
Novartis Investigator Site
Rochester, Minnesota, United States, 55905
United States, New York
Novartis Investigator Site
Great Neck, New York, United States, 11021
Novartis Investigator Site
New York, New York, United States, 10029
United States, North Carolina
Novartis Investigator Site
Chapel Hill, North Carolina, United States, 275997032
Novartis Investigator Site
Greenville, North Carolina, United States, 27834
Novartis Investigator Site
Raleigh, North Carolina, United States, 27612
Canada, Alberta
Novartis Investigator Site
Calgary, Alberta, Canada
Novartis Investigator Site
Edmonton, Alberta, Canada
Canada, Manitoba
Novartis Investigator Site
Winnipeg, Manitoba, Canada
Canada, Ontario
Novartis Investigator Site
London, Ontario, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: NOVARTIS Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00584740     History of Changes
Other Study ID Numbers: CAIN457A2202
Study First Received: December 21, 2007
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Crohn's disease, moderate, severe, active, AIN457

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014