Safety and Efficacy of AIN457 in Noninfectious Uveitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00685399
First received: May 23, 2008
Last updated: November 18, 2013
Last verified: November 2013
  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: Non-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

Resource links provided by NLM:


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 ]

Enrollment: 79
Study Start Date: June 2008
Study Completion Date: September 2013
Primary Completion Date: September 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
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: NCT00685399

  Show 28 Study Locations
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 18, 2013
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 September 18, 2014