The objective of this study is to assess the safety and tolerability of intravenous and subcutaneous AIN457 in patients with uveitis. Initially, this study began with a small cohort of patients with uveitis. Favorable results called for other cohorts to quickly be added: posterior and intermediate uveitis patients, anterior uveitis, and patients with severe Behçets disease were all added in separate cohorts, to evaluate the effectiveness of intravenous AIN457. Cohort 4 was then created; this group was reserved for patients who were successfully in remission on drug treatment, but opted for medical follow-up and the option of infusions as needed, if flare-ups were to occur. Essentially, the drug acts to block IL-17, a specific immunological factor that may be elevated in uveitis, and uveitis-associated diseases (such as sarcoidosis, Behçets disease, VKH disease). AIN457 is a high-affinity human monoclonal antibody. It was developed specifically for the potential treatment of uveitis, rheumatoid arthritis (RA), psoriasis, inflammatory bowel disease (Crohn’s disease), and possibly other inflammatory conditions. AIN457 binds to IL-17 and neutralizes this cytokine.
At present, the sponsor is seeking a sixth cohort of patients to evaluate both method of dosing and dosing amount. In the initial trials, dosing was achieved via systemic infusion. Presently, researchers are evaluating the route of subcutaneous injection as feasible and/or favorable. Subcutaneous injection is quicker and may induce fewer side effects, as compared to lengthy systemic infusions. Eligible patients will be randomized into one of two arms of study. All patients will receive both an infusion and subcutaneous injection; however, it will be unknown by the ophthalmologist and the patient which treatment method contains active drug.
Eligible patients will be any patients with posterior, intermediate or panuveitis of non-infectious etiology who require immunosuppression. Certain medications may preclude patients from participation, in addition to certain medical conditions.
The duration of this study, without the inclusion of Cohort 4, is approximately 3 months. This includes a screening phase to ensure eligibility, 5 treatment visits (with 4 infusions total), and 1 safety follow-up visit. An ECG and physical exam are performed at the start of the trial. Testing at these visits is similar to a standard ophthalmic visit, and laboratory blood work is taken at each visit, along with pharmacokinetic data.
- Age 18 to 75
- Active, non-infectious posterior, intermediate, or panuveitis
- Consenting, competent adults, willing to comply with all study requirements
- Significant illness
- Infectious uveitis
- Certain medications and drug-eluting devices
The study includes:
- Standard ophthalmic exams
- Laboratory blood work
- Various forms of Vision Assessment
More Information about the Sponsor: Novartis, http://www.novartis.com/.
Principal Investigator: C. Stephen Foster, M.D., F.A.C.S., F.A.C.R.
Research Coordinator: If you feel that you may be eligible for this study and are interested in participating, contact Jamie L. Metzinger (firstname.lastname@example.org 617-494-1431 x155).
If you are a study patient currently enrolled in this study, contact the Institutional Review Board, Quorum Review, at 1-888-776-9115 (Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday). They are able to provide information on patient’s rights.
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