A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

NCT05781750 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: KZR-616-202
• Study Type: interventional
• Target: 84
• Locations: 12 countries
• Sites: 50

Brief Summary

The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).

Conditions

Lupus Nephritis

Keywords

immunoproteasome inhibition; selective immunoproteasome inhibition; complete renal response; partial renal response; glucocorticoids; steroids; SLE (systemic lupus erythematosus); UPCR (urine protein to creatinine ratio); eGFR (estimated glomerular filtration rate)

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving Complete Renal Response

  Proportion of patients achieving complete renal response (CRR), defined as: * A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points) * An eGFR ≥60 mL/min/1.73 m\^2 or no confirmed decrease of \>20% from Baseline eGFR.

  Week 37

Secondary Outcomes (6)

• Proportion of Patients Achieving Partial Renal Response (PRR)

  Week 25 and Week 37

• Proportion of Patients Achieving Complete Renal Response

  Week 25

• Change in UPCR

  Week 13, Week 25, and Week 37

• Time to Complete Renal Response and Partial Renal Response

  Baseline through Week 37

• Proportion of Patients With UPCR ≤0.5

  Week 13, Week 25, and Week 37

Study Arms (3)

zetomipzomib 30 mg + standard-of-care

EXPERIMENTAL

Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.

Drug: zetomipzomib

zetomipzomib 60 mg + standard-of-care

EXPERIMENTAL

Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.

Drug: zetomipzomib

placebo + standard-of-care

PLACEBO COMPARATOR

Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Drug: placebo

Interventions

zetomipzomib DRUG

Subcutaneous injection of zetomipzomib

Also known as: KZR-616

zetomipzomib 30 mg + standard-of-care; zetomipzomib 60 mg + standard-of-care

placebo DRUG

Subcutaneous injection of placebo

Also known as: matching placebo

placebo + standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index of ≥18 kg/m\^2
• eGFR ≥30 mL/min/1.73 m\^2
• Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
• Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
• UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)
• Adequate hematologic, hepatic, and renal function

You may not qualify if:

• Current or medical history of:
• Central nervous system manifestations of SLE
• Overlapping autoimmune condition that may affect study assessments/outcomes
• Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
• Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions
• Solid organ transplant or planned transplant during study
• Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers \>5 years ago
• Has received dialysis within the 52 weeks prior to Screening
• Positive test at Screening for HIV, hepatitis B/C
• Known intolerance to MMF or equivalent and corticosteroids

Sponsors & Collaborators

• Kezar Life Sciences, Inc.: lead

Study Sites (50)

Accurate Clinical Research - Lake Charles

Lake Charles, Louisiana, 70605, United States

Location

Nephrology Associates, Inc

East Providence, Rhode Island, 02914, United States

Location

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, 76034, United States

Location

Prolato Clinical Research Center (PCRC)

Houston, Texas, 77054, United States

Location

Mayo Clinic of UCMB SRL

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

Location

Framingham Medical Center

Buenos Aires, B1902ADW, Argentina

Location

Medical Research Organization

Buenos Aires, C1015, Argentina

Location

Aprillus Assistance and Research by Arcis Health

Buenos Aires, C1406AGA, Argentina

Location

Dr. Doreski Medical Offices

Buenos Aires, C1426ABP, Argentina

Location

Military Central Hospital

Buenos Aires, C1426BOS, Argentina

Location

Austral University Hospital

Pilar, B1629ODT, Argentina

Location

Holy House of Mercy of Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Clinics Hospital FMRP

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Faculty of Medicine of SJRP

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Clinical Hospital FMUSP

São Paulo, 05403-000, Brazil

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Costa Clinica

Barranquilla, Atlántico, 080020, Colombia

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

Center for Advanced Health Clinical Studies

Guatemala City, 01009, Guatemala

Location

Clinical Research Center, S.A.

Guatemala City, 01010, Guatemala

Location

Medical Clinic Specialized in Internal Medicine and Rheumatology

Guatemala City, 01010, Guatemala

Location

Medical Clinic Specialized in Internal Medicine and Rheumatology

Guatemala City, 01011, Guatemala

Location

All India Institute of Medical Sciences

Raipur, Chhattisgarh, 492099, India

Location

Nirmal Hospital

Surat, Guajrat, 395002, India

Location

Unity Hospital

Surat, Guajrat, 395010, India

Location

Panchshil Hospital

Ahmedabad, Gujarat, 380005, India

Location

Elite Mission Hospital

Thrissur, Kerala, 680007, India

Location

MGM Medical College and Hospital

Aurangabad, Maharashtra, 431003, India

Location

Kingsway Hospital

Nagpur, Maharashtra, 440001, India

Location

Jasleen Hospital

Nagpur, Maharashtra, 440012, India

Location

Assured Care Plus Hospital

Nashik, Maharashtra, 422101, India

Location

Sir Ganga Ram Hospital

New Delhi, NCT of Delhi, 110060, India

Location

SMS Medical College

Jaipur, Rajasthan, 302001, India

Location

Yashoda Hospitals

Hyderabad, Telangana, India, India

Location

Krishna Institute of Medical Science

Secunderabad, Telangana, 500003, India

Location

Prince Court Medical Centre

Kuala Lumpur, Kuala Lumpur, 50450, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Hospital Sultan Idris Shah Serdang

Kajang, Selangor, 43000, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Mary Mediatrix Medical Center

Lipa City, Batangas, 4217, Philippines

Location

Iloilo Doctors' Hospital

Iloilo City, Iloilo, 5000, Philippines

Location

ManilaMed - Medical Center Manila

Manila, National Capital Region, 1000, Philippines

Location

St. Luke's Medical Center

Quezon City, National Capital Region, 1102, Philippines

Location

Far Eastern University Hospital Nicanor Reyes Medical Foundation

Quezon City, National Capital Region, 1118, Philippines

Location

University of Santo Tomas Hospital

Manila, 1015, Philippines

Location

Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related Links

• Corporate website

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

KZR-616

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was terminated early for strategic business reasons following the temporary halt of the study per the Independent Data Monitoring Committee's (IDMC's) recommendation. At the time of termination, no participants had completed the full 52-week treatment period. Due to early termination, safety was the primary focus of this study and only limited efficacy data were analyzed.

Results Point of Contact

• Title: Regulatory Affairs
• Organization: Kezar Life Sciences, Inc.

clinicaltrials@kezarbio.com

650-822-5600

Study Officials

• Kezar

  Kezar Life Sciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: November 3, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); BR (4); CN (3); AR (7); IN (13); CO (1); MY (5); PH (6); GR (1); US (4); ZA (1); GU (4)