Active non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy MedDRA version: 20.0 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 100000161411 MedDRA version: 20.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 10000001
Conditions
Interventions
Product Code: LFG316
Pharmaceutical Form: Solution for injection/infusion
Current Sponsor code: LFG316
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female patients 18 years or older •Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy. -Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985, or -Chorioretinal lesions due to uveitis (chorioretinal lesions due to infections will exclude the patient) - Patients who present with a flare and who are at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants will have their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration. - Visual acuity (ETDRS method) of 20 letters (20/400 snellen equivalent) or better in the study eye •Female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception. •Ability to provide informed consent and comply with the protocol. 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Uveitis so severe that, in the investigator's judgment, it is too risky to test an experimental drug •Bilateral uveitis for which, in the opinion of the investigator, systemic immunosuppressive therapy is required to manage the inflammation in the fellow eye; use of local therapy in the fellow eye is acceptable and not an explicit exclusion (see section 5.5.7 for acceptable concomitant treatments) •Uncontrolled glaucoma or ocular hypertension in either eye, defined as an intraocular pressure (IOP) >30 mmHg while on medication for the specific condition •Forms of uveitis that may spontaneously resolve such as multiple evanescent white dot syndrome (MEWDS). •In the opinion of the investigator, clinically significant abnormality in screening laboratory results or electrocardiogram •In the study eye, cataract that is expected to interfere with study conduct or require surgery during the study •History of infectious uveitis or endophthalmitis in either eye •History of retinal detachment •Patients taking corticosteroids or other systemic immunosuppressive medication for any other disease (e.g., asthma or other autoimmune disease) where the tapering of the immunosuppressant would not be safe because of the risk of exacerbation of the extra ocular disease •Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months of screening depending on the agent. •Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Response rate (LFG316 treatment arm) defined as improvement in vitreous haze score, or improvement of visual acuity or improvement in anterior chamber cells (relative to baseline) or resolution of chorioretinal lesions or change in central retinal thickness;Timepoint(s) of evaluation of this end point: Day 85;Main Objective: To assess the effect of intravitreal LFG316 (5 mg q 4 weeks x 3 doses) on the protocol-defined, Day 85 response rate in the study eye of patients who meet the inclusion criteria.; Secondary Objective: • To assess the effect of intravitreal LFG316 (5 mg q 4 weeks x 3 doses) in patients who meet the inclusion criteria. For LFG316 responders who continue into the 6 month treatment extension, assessments will be conducted (according to the assessment schedule) until Day 281 or EOES. • To assess the effect of intravitreal LFG316 (5 mg q 4 weeks x 3 doses) on vitreous haze as measured on the Nussenblatt scale, ETDRS visual acuity, macular edema, presence or absence of choroidal lesions, and anterior chamber cell score in the study eye of patients who meet the inclusion criteria and compare these between baseline and days 2, 8, 15, 29, 43, 57, and 85. For LFG responders who continue into the 6 month treatment extension, assessments will be conducted (according to the assessment schedule) until Day 281 or EOES. • To evaluate the serum concentrations of total LFG316 and total C5 during the course of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate (LFG316 treatment arm): - Mean change BCVA, - Mean change vitreous haze score, - percentage of eyes that respond (as per responder criteria) - AE and SAE rates. ; Timepoint(s) of evaluation of this end point: Response rate at days 2, 8, 15, 29, 57 and 85 | — |
Countries
United Kingdom, United States
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed