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

RECRUITING

I'm interested ...!!

The purpose of this study is 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

🗓️ Study Start (Actual) 3 November 2023

🗓️ Primary Completion (Estimated) May 2026

✅ Study Completion (Estimated) July 2026

👥 Enrollment (Estimated) 279

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Huntsville, Alabama, United States

📍 Surprise, Arizona, United States

📍 Los Alamitos, California, United States

📍 Torrance, California, United States

📍 Miami, Florida, United States

📍 Orlando, Florida, United States

📍 Tamarac, Florida, United States

📍 Columbus, Georgia, United States

📍 East Point, Georgia, United States

📍 Chicago, Illinois, United States

📍 Lake Charles, Louisiana, United States

📍 Great Neck, New York, United States

📍 New York, New York, United States

📍 Columbus, Ohio, United States

📍 Oklahoma City, Oklahoma, United States

📍 Langhorne, Pennsylvania, United States

📍 Upland, Pennsylvania, United States

📍 East Providence, Rhode Island, United States

📍 Providence, Rhode Island, United States

📍 Amarillo, Texas, United States

📍 Colleyville, Texas, United States

📍 Dallas, Texas, United States

📍 Houston, Texas, United States

📍 Lewisville, Texas, United States

📍 Pasadena, Texas, United States

📍 Rosario, Santa Fe, Argentina

📍 San Miguel De Tucumán, Tucumán, Argentina

📍 Buenos Aires, Argentina

📍 Pilar, Argentina

📍 Garran, Australian Capital Territory, Australia

📍 Kogarah, New South Wales, Australia

📍 New Lambton Heights, New South Wales, Australia

📍 Wollongong, New South Wales, Australia

📍 Southport, Queensland, Australia

📍 Clayton, Victoria, Australia

📍 Parkville, Victoria, Australia

📍 St Albans, Victoria, Australia

📍 Salvador, Bahia, Brazil

📍 Brasília, Distrito Federal, Brazil

📍 Brasília, Federal District, Brazil

📍 São Luís, Maranhão, Brazil

📍 Belo Horizonte, Minas Gerais, Brazil

📍 Curitiba, Paraná, Brazil

📍 Porto Alegre, Rio Grande Do Sol, Brazil

📍 Porto Alegre, Rio Grande Do Sul, Brazil

📍 Joinville, Santa Catarina, Brazil

📍 Ribeirão Preto, São Paulo, Brazil

📍 Santo André, São Paulo, Brazil

📍 São Bernardo Do Campo, São Paulo, Brazil

📍 São José Do Rio Preto, São Paulo, Brazil

📍 Rio De Janeiro, Brazil

📍 São Paulo, Brazil

📍 Xiamen, Fujian, China

📍 Guangzhou, Guangdong, China

📍 Shenzhen, Guangdong, China

📍 Wuhan, Hubei, China

📍 Changsha, Hunan, China

📍 Nantong, Jiangsu, China

📍 Xuzhou, Jiangsu, China

📍 Changchun, Jilin, China

📍 Binzhou, Shandong, China

📍 Mianyang, Sichuan, China

📍 Kunming, Yunnan, China

📍 Hangzhou, Zhejiang, China

📍 Taizhou, Zhejiang, China

📍 Wenzhou, Zhejiang, China

📍 Barranquilla, Atlántico, Colombia

📍 Zipaquirá, Cundinamarca, Colombia

📍 Bucaramanga, Santander, Colombia

📍 Cali, Valle De Cauca, Colombia

📍 Split, Croatia

📍 Zagreb, Croatia

📍 Athens, Greece

📍 Larisa, Greece

📍 Thessaloniki, Greece

📍 Guatemala City, Guatemala

📍 Guatemala, Guatemala

📍 Raipur, Chhattisgarh, India

📍 Surat, Guajrat, India

📍 Ahmedabad, Gujarat, India

📍 Belgaum, Karnataka, India

📍 Thrissur, Kerala, India

📍 Aurangabad, Maharashtra, India

📍 Nagpur, Maharashtra, India

📍 Nashik, Maharashtra, India

📍 New Delhi, NCT Of Delhi, India

📍 Jaipur, Rajasthan, India

📍 Ranipet, Tamil Nadu, India

📍 Hyderabad, Telangana, India

📍 Secunderabad, Telangana, India

📍 Kolkata, West Bengal, India

📍 Gyeonggi-do, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Kuantan, Pahang, Malaysia

📍 Ipoh, Perak, Malaysia

📍 Batu Caves, Selangor, Malaysia

📍 Kajang, Selangor, Malaysia

📍 Kuala Lumpur, Wilayah Persekutuan, Malaysia

📍 Kuala Lumpur, Malaysia

📍 Kuala Selangor, Malaysia

📍 Lima, Peru

📍 Lipa City, Batangas, Philippines

📍 Iloilo City, Iloilo, Philippines

📍 Manila City, National Capital Region, Philippines

📍 Quezon City, National Capital Region, Philippines

📍 Manila, Philippines

📍 Braga, Portugal

📍 Carnaxide, Portugal

📍 Guimarães, Portugal

📍 Lisboa, Portugal

📍 Porto, Portugal

📍 Setúbal, Portugal

📍 San Juan, Puerto Rico

📍 Belgrade, Serbia

📍 Kragujevac, Serbia

📍 Krusevac, Serbia

📍 Niš, Serbia

📍 Singapore, Singapore

📍 Port Elizabeth, Eastern Cape, South Africa

📍 Germiston, Gauteng, South Africa

📍 Cape Town, Western Cape, South Africa

📍 L'Hospitalet De Llobregat, Barcelona, Spain

📍 Pamplona, Navarra, Spain

📍 Barcelona, Spain

📍 Lleida, Spain

📍 Madrid, Spain

📍 Sevilla, Spain

📍 Kaohsiung, Taiwan

📍 Keelung, Taiwan

📍 New Taipei, Taiwan

📍 Taichung, Taiwan

📍 Taoyuan, Taiwan

📍 Derby, Derbyshire, United Kingdom

📍 Salford, Greater Manchester, United Kingdom

📍 Headington, Oxford, United Kingdom

📍 Sunderland, Tyne And Wear, United Kingdom

📍 London, UK, United Kingdom

📍 Leicester, United Kingdom

📍 London, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 12 March 2023
First Submitted that Met QC Criteria 12 March 2023
First Posted 23 March 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 23 July 2024
Last Update Posted 25 July 2024
Last Verified July 2024