Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)
NCT02176486 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2019-04-08
Summary
The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.
Conditions
Interventions
- DRUG
-
Ixazomib
Ixazomib capsules.
- DRUG
-
Ixazomib placebo-matching capsules.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director Clinical Science · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-09
- Primary Completion
- 2017-03-30
- Completion
- 2018-01-19
- FDA Drug
- Yes
Countries
- United States
- France
- Germany
- Italy
- Russia
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
NCT04564339 ·Status: TERMINATED ·Phase: PHASE2
-
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
NCT03771885 ·Status: WITHDRAWN ·Phase: PHASE1
-
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
NCT03943147 ·Status: TERMINATED ·Phase: PHASE2
-
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
NCT02770170 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
NCT02547922 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 in Lupus Nephritis
NCT04924296 ·Status: UNKNOWN ·Phase: PHASE2
-
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
NCT04136145 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus
NCT02411136 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)
NCT05540665 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT02725515 ·Status: COMPLETED ·Phase: PHASE2
-
Japanese phase1 Study of Belimumab (IV vs SC)
NCT01516450 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
NCT00626197 ·Status: TERMINATED ·Phase: PHASE3
-
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
NCT00818948 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
NCT05781750 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
NCT07299422 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
NCT02291588 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus
NCT02437890 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
NCT06261021 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
NCT02446912 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
NCT04181762 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
NCT01085097 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants
NCT05278663 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus
NCT02920424 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
NCT04128579 ·Status: COMPLETED ·Phase: PHASE1
-
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
NCT06717815 ·Status: RECRUITING ·Phase: PHASE1/PHASE2