A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis

Conditions

Autoimmune disease

Brief summary

The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.

Detailed description

The key secondary efficacy endpoints will evaluate the proportion of patients achieving the following: • PRR at Week 25, Week 37, and Week 53 • CRR at Week25 and Week 53 The other secondary efficacy endpoints include the following: • Percentage change from Baseline in UPCR by visit • Time to event (CRR, PRR, death or renal event), • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with successful taper of prednisone or equivalent by Week 17 • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with no use of prednisone or equivalent during the 8 weeks prior to the renal response assessment • Proportion of patients with UPCR ≤0.5 at Weeks 13, 25, 37, and 53, • Proportion of patients achieving CRR with UPCR ≤ upper limit of normal (ULN) at Weeks 25, 37, and 53 • Change from Baseline in clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, excluding complement and anti-dsDNA components • Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Related papers

No related papers found yet.

Interventions

DRUGMETHYLPREDNISOLONE

DRUG-

DRUGMyfenax 500 mg film-coated tablets

DRUGSterile Water For Injection

DRUG0.92 mL (Prefilled Syringe)

DRUGsterilized lyophilized powder with no active

DRUGMethylprednisolon acis 1000 mg Pulver und Lösungsmittel zur Herstellung einer Injektions- bzw. Infusionslösung

DRUGZETOMIPZOMIB (KZR-616)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.	—

Secondary

Measure	Time frame
The key secondary efficacy endpoints will evaluate the proportion of patients achieving the following: • PRR at Week 25, Week 37, and Week 53 • CRR at Week25 and Week 53 The other secondary efficacy endpoints include the following: • Percentage change from Baseline in UPCR by visit • Time to event (CRR, PRR, death or renal event), • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with successful taper of prednisone or equivalent by Week 17 • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with no use of prednisone or equivalent during the 8 weeks prior to the renal response assessment • Proportion of patients with UPCR ≤0.5 at Weeks 13, 25, 37, and 53, • Proportion of patients achieving CRR with UPCR ≤ upper limit of normal (ULN) at Weeks 25, 37, and 53 • Change from Baseline in clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, excluding complement and anti-dsDNA components • Change from Baseline in EuroQol 5-Dimension 5	—

Measure

Time frame

The key secondary efficacy endpoints will evaluate the proportion of patients achieving the following: • PRR at Week 25, Week 37, and Week 53 • CRR at Week25 and Week 53 The other secondary efficacy endpoints include the following: • Percentage change from Baseline in UPCR by visit • Time to event (CRR, PRR, death or renal event), • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with successful taper of prednisone or equivalent by Week 17 • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with no use of prednisone or equivalent during the 8 weeks prior to the renal response assessment • Proportion of patients with UPCR ≤0.5 at Weeks 13, 25, 37, and 53, • Proportion of patients achieving CRR with UPCR ≤ upper limit of normal (ULN) at Weeks 25, 37, and 53 • Change from Baseline in clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, excluding complement and anti-dsDNA components • Change from Baseline in EuroQol 5-Dimension 5

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Countries

Croatia, France, Germany, Greece, Italy, Portugal, Spain

Outcome results

None listed