A 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis (ENDURE Study) - ENDURE, C2301
- Conditions
- Demonstrate the efficacy and safety of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis or panuveitis requiring systemic immunosuppressionMedDRA version: 12.0Level: LLTClassification code 10022941Term: Iridocyclitis
- Registration Number
- EUCTR2009-014835-19-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Male and female subjects =18 years of age
2.Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by <1+ anterior chamber cell grade and <1+ vitreous haze in both eyes for at least 6 weeks prior to screening
3.Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening:
•Prednisone or equivalent =10 mg daily
•=1 periocular injection or =1 intravitreal corticosteroid injection (i.e. 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 as monotherapy or in combination with or without steroids. (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
4.Patients must be willing to be weaned from their current systemic immunosuppressive therapy.
5.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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.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)
2.Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes (=1+ anterior chamber cells and /or =1+ vitreous haze)
3.Patients receiving or that may require corticosteroids (prednisone or equivalent) =1 mg/kg/day to maintain quiescence of their intraocular inflammation.
4.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 (i.e. ocular lymphoma).
5.Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
6.Treatment with fluocinolone acetonide implant (Retisert®) 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.
7.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.
8.Planned elective ocular surgery during the study.
9.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 (i.e. uncontrolled glaucoma, toxoplasma scar, macular scarring).
10.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
11.Any previous treatment with AIN457
12.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.
13.Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening.
14.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.
15.Active systemic infections during the last two weeks prior to screening (exception: common cold)
16.Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patients and/or places the patient at an unacceptable risk for participation in an immunomodulatory therapy.
17.Systemic or extraocular disease that would contraindicate long-term immunosuppression, especially infectious diseases such as:
•any active, chronic or localized infection
•a history of an infectious disease that can spontaneously re-emerge or that are impossible to completely cure, such as histopl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method