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A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis
A study for subjects with Lupus nephritis using an oral study drug MLN9708
| Sponsor: | Takeda |
| Enrolling: | Male and Female Patients |
| Study Length: | 168 Days |
| Clinic Visits: | 19 |
| IRB Number: | AAAN9210 |
| U.S. Govt. ID: | NCT02176486 |
| Contact: | Anca Askanase MD MPH: 212-305-0856 / ada20@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is to evaluate the safety and tolerability of an experimental investigational drug called ixazomib citrate (MLN9708) in patient with Lupus Nephritis. Lupus nephritis is a condition when the kidney is affected in the autoimmune disease known as systemic lupus erythematosus (SLE). SLE is a disease in which the immune system (the body system that fights infection) attacks your own cells and tissues, causing inflammation and candamage organs in the body. Lupus nephritis is a serious manifestation of SLE. In addition, this study will compare ixazomib citrate with a placebo to see if taking ixazomib citrate is better than taking a placebo. The placebo is a capsule that looks like a drug but has no drug in it.
This study is closed
Do You Qualify?
| Do you have a diagnosis of lupus erythematosus (SLE)? | Yes | No |
| Do you have a definite diagnosis of lupus nephritis (LN)? | Yes | No |
| Should you qualify, would you agree to use two effective methods of contraception, at the same time, throughout the study? | Yes | No |
| Are you pregnant, lactating, or intend to become pregnancy before or during the study? | Yes | No |