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

Active, not recruiting

• Conditions: quiescent, non-infectious intermediate, posterior or panuveitis; MedDRA version: 12.1Level: LLTClassification code 10033687Term: Panuveitis

• Registration Number: EUCTR2009-014835-19-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 232

Inclusion 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

Exclusion Criteria

Ocular concomitant conditions/disease. 1. Patients should be excluded: Uveitis secondary to Beh?et’s disease; Anterior uveitis; Any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve without treatment; Any intermediate uveitis, posterior uveitis or panuveitis in which the patients history or the clinical manifestations of the disease are not characterized by the presence of either anterior chamber cells or vitritis such as the white dot retino-choroidopathies, acute zonal occult outer retinopathy. 2. Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes. 3. Patients receiving or that may require corticosteroids =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.
Ocular treatments. 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. 10. Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve
Systemic conditions or treatments. 11. Any previous treatment with AIN457. 12. Any systemic biologic therapy given intravenously or subcutaneously within 3 months prior to screening.. 13. Any prior treatment with systemic alkylating agents within the past 5 years prior to screening. 14. Treatment with any live or live-attenuated vaccine within 2 months prior to screening. 15. Active systemic infections during the last two weeks prior to screening. 16. Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient 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. 18. History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years of any organ system. 20. Any medical or psychiatric condition which, in the investigator’s opinion would preclude the participant from adhering to the protocol or completing the study per protocol.
Compliance/Administrative. 21. Inability or unwillingness to undergo repeated subcutaneous injections. 22. Inability or unwillingness to receive treatment with oral corticosteroids if recommended by the study investigator. 23. Participation in any other interventional study within 4 weeks prior to screening, and for any other limitation of participation based on local regulations. 24. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, c

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified