Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0 Level: LLT Classification code 10036370 Term: Posterior uveitis
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Population: Patients with intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease enrolled in the core study. In the extension study patients may elect to continue study treatments (Group 1) or only to complete the treatment-free safety follow-up period (Group 2). Inclusion for Group 1: • Patients who have completed the entire treatment period of the 24-week core study • Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed. Inclusion for Group 2: • Patients who were randomized into 24-week core study and did not complete the treatment period or will not continue in the extension treatment phase. 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
Exclusion criteria: Exclusion for Group 1: • Inability or unwillingness to undergo repeated subcutaneous injections • Inability to comply with study or follow-up procedures. • 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. • Active systemic infections during the last two weeks (exception: common cold) prior Visit16 that in the opinion of the study investigator or sponsor that would be a contraindication to additional treatment with AIN457. • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) • Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant There are no Exclusion criteria for Group 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet’s patients with intermediate uveitis, posterior uveitis or panuveitis in Group 1;Secondary Objective: Key secondary: • To determine if continuous treatment with subcutaneous AIN457 can reduce the need for standard-of-care immunosuppressive medications in Group 1 patients requiring systemic immunosuppression to treat or prevent intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease Secondary: • To allow for an adequate treatment-free safety follow up period (12 weeks post-treatment) for patients who discontinued treatment in the core study or who have completed the treatment period in the core study and do not wish to continue study treatment in the extension study (Group 2) ;Primary end point(s): The rationale for the additional 26 weeks of treatment following the 24 week core study is to provide additional data on the safety and efficacy of AIN457 given over the course of 1 year. The rationale for the monthly dosing of the study treatment in the extension study is to determine if it is necessary to maintain high plasma concentrations of AIN457 (equivalent to 10 mg/kg i.v.) to maximize efficacy or whether maximal efficacy can be maintained with lower plasma concentrations (equivalent to 3 mg/kg i.v.) after exposure to high plasma concentrations for 24 weeks or lower AIN457 plasma concentrations maintained over the course of 1 year. The observation of the disease course during the extension study will help to define the optimum AIN457 dosing regimen longterm. | — |
Countries
Austria, France, Germany, Greece, Spain
Outcome results
None listed