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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01095250
Other study ID # CAIN457C2302
Secondary ID 2009-014834-22
Status Terminated
Phase Phase 3
First received March 25, 2010
Last updated October 5, 2015
Start date April 2010
Est. completion date October 2010

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Greece: National Organization of MedicinesHungary: National Institute of PharmacyCanada: Health CanadaEgypt: Ministry of Health and PopulationJapan: Ministry of Health, Labor and WelfareSingapore: Department of Health 3/F, Public Health Laboratory CentreSwitzerland: SwissmedicGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of MedicinesItaly: Comitato Etico per la Sperimentazione Clinica dei Medicinali Dell'Azienda Ospedaliero -Universitaria Careggi di FirenzeTurkey: IEGM (The General Directorate of Pharmaceuticals and Pharmacy)United Kingdom: Medicines and Healthcare Products Regulatory AgencyIndia: Ministry of HealthIsrael: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male and female subjects =18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations

- Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye

- Evidence of active intermediate, posterior or panuveitis (grade = 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye

- Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis:

- Prednisone or equivalent =10 mg daily at any time within the past 3 months.

- =1 periocular injection or =1 intravitreal corticosteroid injection (e.g. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening).

- Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study).

- Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator.

- Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed

Exclusion Criteria:

Ocular concomitant conditions/disease

- Patients receiving or that may require prednisone (or equivalent) =1.5 mg/kg/day for the treatment of their active uveitis

- Patients with a primary diagnosis of Behcet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR)

- Patients with infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma)

Ocular treatments

- Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening

- Treatment with fluocinolone acetonide implant in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.

- Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle

- Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract, vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation of the safety or efficacy of the study treatment (e.g. uncontrolled glaucoma, toxoplasma scar, macular scarring)

- Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine, ethambutol, etc.)

Systemic conditions or treatments

- Any previous treatment with AIN457

- Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial

- Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening

- Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AIN457

AIN457

AIN457

Placebo


Locations

Country Name City State
Canada Novartis Investigative Site London Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site North York Ontario
Egypt Novartis Investigative Site Cairo
France Novartis Investigative Site Nantes
Germany Novartis Investigative Site Freiburg
Germany Novartis Investigative Site Göttingen
Hungary Novartis Investigative Site Budapest
India Novartis Investigative Site Ahmedabad Gujarat
Israel Novartis Investigative Site Afula
Israel Novartis Investigative Site Petach Tikva
Israel Novartis Investigative Site Ramat Gan
Israel Novartis Investigative Site Tel-Aviv
Japan Novartis Investigative Site Bunkyo-ku Tokyo
Japan Novartis Investigative Site Fukuoka-city Fukuoka
Japan Novartis Investigative Site Fukushima-city Fukushima
Japan Novartis Investigative Site Kyoto
Japan Novartis Investigative Site Mitaka-city Tokyo
Japan Novartis Investigative Site Osaka-city Osaka
Japan Novartis Investigative Site Sapporo-city Hokkaido
Japan Novartis Investigative Site Shimotsuka-gun Tochigi
Japan Novartis Investigative Site Suita-city Osaka
Singapore Novartis Investigative Site Singapore
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Lausanne CHE
Switzerland Novartis Investigative Site Luzern
Switzerland Novartis Investigative Site St. Gallen
United Kingdom Novartis Investigative Site York
United States Novartis Investigative Site Arlington Texas
United States Novartis Investigative Site Beverly Hills California
United States Novartis Investigative Site Cambridge Massachusetts
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Slingerlands New York

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Egypt,  France,  Germany,  Hungary,  India,  Israel,  Japan,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
Secondary Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
Secondary Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
Secondary Change From Baseline in Quality of Life/Patient Reported Outcome Assessments No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
Secondary Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
Secondary Change in Immunosuppressive Medication Score From Baseline to Week 28 No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided. baseline to 28 weeks No
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