Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis (SHIELD)

A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000874

Enrollment

117

Registered

2010-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Biological: AIN457: AIN457C 300 mg every 2 week dosage regimen Intervention2: Biological: AIN457: AIN457C 300 mg monthly dosage regimen Control Intervention1: Placebo: Placebo Comparato

Eligibility

Inclusion criteria

Inclusion criteria: Male and female subjects greater than18 years of age 2. Patients with Behcets 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) posterior uveitis or panuveitis secondary to Behcets disease at the time of screening are eligible for the study. The diagnosis of Behcets disease lies in the judgment of the investigator. Criteria for the diagnosis of Behcets disease according to the International Uveitis Study Group criteria and the Behcets Disease Research Committee criteria (complete or incomplete type) are provided Appendix 2. 3. Documented evidence of greater than2 recurrent exacerbations of either 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. greater than2+ vitreous haze with less than2+ anterior chamber cell grade (posterior uveitis) or greater than2+ vitreous haze with greater than2+ anterior chamber cell grade (panuveitis) b. presence of retinal infiltrates or vasculitis or hemorrhages c. documented greater than10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behcets disease. 4. 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 Behcets disease a. Prednisone or equivalent greater than10 mg daily b. The need for at least greater than1 periocular injection or greater than1 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

Exclusion criteria

Exclusion criteria: . Subjects with infectious uveitis, uveitis due to other causes than Behcets disease, or uveitis of unknown etiology. .Less severe (i.e. anterior or intermediate) uveitis associated with Behcets disease

Design outcomes

Primary

Measure	Time frame
To determine if AIN457 is effective in reducing the rate of posterior segment uveitis exacerbations secondary to Behçet's disease, as assessed by visual acuity, anterior chamber cells and vitreous haze.Timepoint: Wk 1-8; wk 12; wk 16; wk 22, and wk 24	—

Secondary

Measure	Time frame
To assess the safety of targeted IL-17 inhibition with AIN457 in patients with posterior segment uveitis secondary to Behçet's disease receiving standard-of-care immunomodulatory therapy as measured by applanation tonometry and adverse events.Timepoint: 24 weeks;To determine if AIN457 can reduce the need for standard-of-care immunosuppressive medications (ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçet's disease as measured by the ISM score.Timepoint: 24 weeks;To determine the effect of AIN457 on macular edema and visual acuity in patients with posterior segment uveitis secondary to Behçet's disease as determined by optical coherence tomography.Timepoint: screening, baseline, and wk 24 (end of study);To establish the impact of AIN457 on quality of life of posterior segment uveitis patients secondary to Behçet's disease refractory to systemic immunomodulatory therapy as measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.Timepoint: screening, and wk 24 (end of study);To observe the effect of AIN457 on the systemic non-ocular manifestations of Behçet's disease in patients with posterior segment uveitis requiring systemic immunosuppression as measured by the Bechet's disease current activity form.Timepoint: baseline and wk 24 (end of study)	—

Measure

Time frame

To assess the safety of targeted IL-17 inhibition with AIN457 in patients with posterior segment uveitis secondary to Behçet's disease receiving standard-of-care immunomodulatory therapy as measured by applanation tonometry and adverse events.Timepoint: 24 weeks;To determine if AIN457 can reduce the need for standard-of-care immunosuppressive medications (ISM) in patients requiring systemic immunosuppression to treat/prevent posterior segment uveitis secondary to Behçet's disease as measured by the ISM score.Timepoint: 24 weeks;To determine the effect of AIN457 on macular edema and visual acuity in patients with posterior segment uveitis secondary to Behçet's disease as determined by optical coherence tomography.Timepoint: screening, baseline, and wk 24 (end of study);To establish the impact of AIN457 on quality of life of posterior segment uveitis patients secondary to Behçet's disease refractory to systemic immunomodulatory therapy as measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.Timepoint: screening, and wk 24 (end of study);To observe the effect of AIN457 on the systemic non-ocular manifestations of Behçet's disease in patients with posterior segment uveitis requiring systemic immunosuppression as measured by the Bechet's disease current activity form.Timepoint: baseline and wk 24 (end of study)

—

Countries

India

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com02224958533

Outcome results