E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
posterior uveitis or panuveitis secondary to Beh�et`s disease |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial is to determine the efficacy of subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Beh�ets patients with posterior uveitis or panuveitis who are receiving standard-of-care immunomodulatory therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary key objective: �� Determine if subcutaneous AIN457 can reduce the need for standard-of-care immunosuppressive medications in patients requiring systemic immunosuppression to treat or prevent posterior uveitis or panuveitis secondary to Beh�ets disease |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria �� Male and female subjects >18 years of age �� Patients with Beh�ets disease and with a history of recurrent uveitis in a least one eye. Patients with both active (experiencing an acute exacerbation) and quiescent (in between exacerbations) intermediate uveitis, posterior uveitis or panuveitis secondary to Beh�ets disease at the time of screening are eligible for the study. The diagnosis of Beh�ets disease lies in the judgment of the investigator. Criteria for the diagnosis of Beh�ets disease according to the International Uveitis Study Group criteria and the Beh�ets Disease Research Committee criteria (complete or incomplete type) are provided Appendix 2. �� Documented evidence of >2 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at screening). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients medical record for each recurrent exacerbation: a. >2+ vitreous haze with <2+ anterior chamber cell grade (intermediate or posterior uveitis) or >2+ vitreous haze with >2+ anterior chamber cell grade (panuveitis) b. presence of retinal infiltrates or vasculitis or hemorrhages c. documented >10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Beh�ets disease. �� Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Beh�ets disease a. Prednisone or equivalent >10 mg daily b. The need for at least >1 periocular injection or >1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening) c. Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.) Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator |
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E.4 | Principal exclusion criteria |
Exclusion criteria Ocular concomitant conditions/disease �� Subjects with infectious uveitis, uveitis due to other causes than Beh�ets disease, or uveitis of unknown etiology. �� Less severe (i.e. anterior) uveitis associated with Beh�ets disease Ocular treatments �� Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening �� Treatment with any injected or implantable corticosteroid releasing device (i.e. flucinolone acetonide implant, Retisert) in the study eye within the last 3 years. �� 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. �� Planned elective ocular surgery during the study. �� 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). �� 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 �� Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening. �� Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457. �� Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil). �� History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years (except for non-melanoma skin cancer that has been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix, colon polyps with non-invasive malignancy that have been removed) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this trial is to determine the efficacy of subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Beh�ets patients with posterior uveitis or panuveitis who are receiving standard-of-care immunomodulatory therapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |