Text Size

Safety and Efficacy of AIN457 in Noninfectious Uveitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00685399
First received: May 23, 2008
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.


Condition Intervention Phase
Active Uveitis That is Not From an Infection.
 Drug: AIN457 subcutaneous dose
Drug: AIN457 low dose (i.v)
Drug: AIN457 high dose (i.v)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety assessments will include ocular examinations, physical examination, and adverse events [ Time Frame: Baseline day through nine months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in ocular inflammation [ Time Frame: One week through nine months ] [ Designated as safety issue: No ]
  • Reduction in other immunosuppressant drugs [ Time Frame: One week through nine months ] [ Designated as safety issue: No ]
  • Ability to induce a remission in uveitis [ Time Frame: one week through nine months ] [ Designated as safety issue: No ]
  • Duration of remission in uveitis [ Time Frame: one week through nine months ] [ Designated as safety issue: No ]
  • Ability to re-induce a remission if a flare-up occurs [ Time Frame: One week through nine months ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: June 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AIN457 subcutaneous dose
Experimental: 2 Drug: AIN457 low dose (i.v)
Experimental: 3 Drug: AIN457 high dose (i.v)

  Eligibility

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

Inclusion criteria:

  • Active uveitis (i.e., uveitis that is not in remission).
  • Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.

Exclusion criteria:

  • Active infection.
  • Weight must not be greater that 120kg.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685399

Locations
United States, California
Novartis Investigative Site
Beverly Hills, California, United States, 90211
Novartis Investigative Site
Los Angeles, California, United States, 90033
Novartis Investigative Site
Sacramento, California, United States, 95819
United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80210
Novartis Investigative Site
Golden, Colorado, United States, 80401
Novartis Investigative Site
Littleton, Colorado, United States, 80120
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30322
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21201
Novartis Investigative Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novartis Investigative Site
Cambridge, Massachusetts, United States, 02142
United States, Missouri
Novartis Investigative Site
Kansas City, Missouri, United States, 64111
United States, New Jersey
Novartis Investigative Site
Teaneck, New Jersey, United States, 07666
United States, New York
Novartis Investigative Site
New York, New York, United States, 10022
Novartis Investigative Site
Slingerlands, New York, United States, 12159
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Ohio
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
United States, South Carolina
Novartis Investigative Site
Spartanburg, South Carolina, United States, 29306
United States, Texas
Novartis Investigative Site
Arlington, Texas, United States, 76012
Novartis Investigative Site
Austin, Texas, United States, 78793
Novartis Investigative Site
Houston, Texas, United States, 77030
Germany
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Heidelberg, Germany, 691120
Novartis Investigative Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00685399     History of Changes
Other Study ID Numbers: CAIN457A2208, 2011-001243-67
Study First Received: May 23, 2008
Last Updated: November 7, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Uveitis,
eye,
IL-17,
IL-17A,
IL17,
AIN457,
Vogt-Koyanagi-Harada,
Behcet's,
Behcet,
Sympathetic ophthalmia,
 Multifocal choroiditis,
Birdshot,
HLA-B27,
Birdshot retinochoroiditis,
Retinal vasculitis,
Sarcoidosis,
Intermediate uveitis,
Panuveitis,
Posterior uveitis

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
 Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on May 16, 2013