Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Takeda

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director Clinical Science

Principal Investigator

Takeda

Eligibility Criteria

Inclusion Criteria

In the opinion of the investigator, is capable of understanding and complying with protocol requirements.

The participant or, when applicable, the participant's legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Is female or male and aged 18 to 75 years, inclusive.

Treatment Details

Interventions

• Ixazomib (Proteasome Inhibitor)
• Placebo (Other)

Participant Groups

Group I: Cohort D: Ixazomib 4 mg Experimental Treatment 1 Intervention

Ixazomib 4 mg, capsules, orally, once, on Day 1, 8 and 15 in 28-day cycles, Cycles 1 through 3.

Group II: Cohort C: Ixazomib 3 mg Experimental Treatment 1 Intervention

Ixazomib 3 mg, capsules, orally, once, on Day 1, 8 and 15 in 28-day cycles, Cycles 1 through 3.

Group III: Cohort B: Ixazomib 2 mg Experimental Treatment 1 Intervention

Ixazomib 2 mg, capsules, orally, once, on Day 1, 8 and 15 in 28-day cycles, Cycles 1 through 3.

Group IV: Cohort A: Ixazomib 0.5 milligram (mg) Experimental Treatment 1 Intervention

Ixazomib 0.5 mg, capsules, orally, once, on Day 1, 8 and 15 in 28-day cycles, Cycles 1 through 3.

Group V: Cohorts A through D: Placebo Placebo Group 1 Intervention

Ixazomib placebo-matching capsules, orally, once on Days 1, 8 and 15 in 28-day cycle, Cycles 1 through 3.

Ixazomib is already approved in Canada, Japan for the following indications:

Approved in Canada as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Approved in Japan as Ninlaro for:

• Multiple myeloma in combination with lenalidomide and dexamethasone

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NCT02176486 Brooklyn, NY

NCT02176486 Manhasset, NY

NCT02176486 New York, NY

NCT02176486 Port Charlotte, FL

More Trial Locations

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1255

Patients Recruited

4,219,000+