Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

RECRUITING

I'm interested ...!!

The purpose of this study is to assess the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

Conditions:

🦠 Lupus Nephritis

🗓️ Study Start (Actual) 15 February 2022

🗓️ Primary Completion (Estimated) 30 September 2026

✅ Study Completion (Estimated) 7 July 2028

👥 Enrollment (Estimated) 346

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Birmingham, Alabama, United States

📍 Glendale, Arizona, United States

📍 La Jolla, California, United States

📍 Loma Linda, California, United States

📍 Los Angeles, California, United States

📍 Orange, California, United States

📍 Upland, California, United States

📍 New Haven, Connecticut, United States

📍 Newark, Delaware, United States

📍 Hallandale Beach, Florida, United States

📍 Plantation, Florida, United States

📍 Sun City Center, Florida, United States

📍 Atlanta, Georgia, United States

📍 Louisville, Kentucky, United States

📍 Saint Louis, Missouri, United States

📍 Las Vegas, Nevada, United States

📍 Newark, New Jersey, United States

📍 Summit, New Jersey, United States

📍 Las Cruces, New Mexico, United States

📍 Great Neck, New York, United States

📍 Manhasset, New York, United States

📍 New York, New York, United States

📍 Winston-Salem, North Carolina, United States

📍 Middleburg Heights, Ohio, United States

📍 Danville, Pennsylvania, United States

📍 Allen, Texas, United States

📍 Colleyville, Texas, United States

📍 Edinburg, Texas, United States

📍 El Paso, Texas, United States

📍 Houston, Texas, United States

📍 Buenos Aires, Argentina

📍 Caba, Argentina

📍 Cordoba, Argentina

📍 La Plata, Argentina

📍 Rosario, Argentina

📍 San Juan, Argentina

📍 San Miguel de Tucuman, Argentina

📍 Bruxelles, Belgium

📍 Leuven, Belgium

📍 Liège, Belgium

📍 Belo Horizonte, Brazil

📍 Maringá, Brazil

📍 Porto Alegre, Brazil

📍 Recife, Brazil

📍 Salvador, Brazil

📍 Sao Jose Do Rio Preto, Brazil

📍 Sao Paulo, Brazil

📍 São Paulo, Brazil

📍 Plovdiv, Bulgaria

📍 Sofia, Bulgaria

📍 Beijing, China

📍 Bengbu, China

📍 Chengdu, China

📍 Guangzhou, China

📍 Haikou, China

📍 Hangzhou, China

📍 Jinan, China

📍 Jining, China

📍 Nanchang, China

📍 Nanjing, China

📍 Nanning, China

📍 Shanghai, China

📍 Shengyang, China

📍 Shenzhen, China

📍 Tianjin, China

📍 Wuhan, China

📍 Wuxi, China

📍 Xi'an, China

📍 Zhengzhou City, China

📍 Barranquilla, Colombia

📍 Cali, Colombia

📍 Medellin, Colombia

📍 Medellín, Colombia

📍 Aurillac Cedex, France

📍 Bordeaux Cedex, France

📍 Marseille, France

📍 Paris, France

📍 STRASBOURG Cedex, France

📍 Toulouse, France

📍 Dresden, Germany

📍 Düsseldorf, Germany

📍 Essen, Germany

📍 Goettingen, Germany

📍 Hannover, Germany

📍 Heidelberg, Germany

📍 Kirchheim, Germany

📍 Köln, Germany

📍 Mainz Am Rhein, Germany

📍 Stuttgart, Germany

📍 Budapest, Hungary

📍 Debrecen, Hungary

📍 Pécs, Hungary

📍 Ahmedabad, India

📍 Dehradun, India

📍 Delhi, India

📍 Gurugram, India

📍 Nadiad, India

📍 New Delhi, India

📍 Pune, India

📍 Secunderabad, India

📍 Vijayawada, India

📍 Visakapatnam, India

📍 Ancona, Italy

📍 Brescia, Italy

📍 Cona, Italy

📍 Monza, Italy

📍 Padova, Italy

📍 Roma, Italy

📍 Bunkyo-ku, Japan

📍 Chiba-shi, Japan

📍 Chuo-ku, Japan

📍 Fukuoka-shi, Japan

📍 Gifu-shi, Japan

📍 Hiroshima-shi, Japan

📍 Izumo-shi, Japan

📍 Kita-gun, Japan

📍 Kitakyushu-shi, Japan

📍 Matsumoto-shi, Japan

📍 Nagasaki-shi, Japan

📍 Okayama, Japan

📍 Ono, Japan

📍 Osaka-shi, Japan

📍 Sagamihara-shi, Japan

📍 Sapporo-shi, Japan

📍 Sendai-shi, Japan

📍 Shinagawa-ku, Japan

📍 Shinjuku-ku, Japan

📍 Toyoake-shi, Japan

📍 Batu Caves, Malaysia

📍 Ipoh, Malaysia

📍 Kajang, Malaysia

📍 Kuala Lumpur, Malaysia

📍 Kuantan, Malaysia

📍 Taiping, Malaysia

📍 Chihuahua, Mexico

📍 Guadalajara, Mexico

📍 Mexico, Mexico

📍 México, Mexico

📍 San Luis Potosi, Mexico

📍 Amsterdam, Netherlands

📍 Bellavista, Peru

📍 Lima, Peru

📍 Piura, Peru

📍 Bydgoszcz, Poland

📍 Nadarzyn, Poland

📍 Olsztyn, Poland

📍 Opole, Poland

📍 Poznań, Poland

📍 Rzeszów, Poland

📍 Szczecin, Poland

📍 Warszawa, Poland

📍 Wrocław, Poland

📍 Łódź, Poland

📍 Chelyabinsk, Russian Federation

📍 Krasnoyarsk, Russian Federation

📍 Moscow, Russian Federation

📍 Novosibirsk, Russian Federation

📍 Orenburg, Russian Federation

📍 St. Petersburg, Russian Federation

📍 Kaohsiung, Taiwan

📍 New Taipei City, Taiwan

📍 Taichung, Taiwan

📍 Taipei City, Taiwan

📍 Taipei, Taiwan

📍 Taoyuan, Taiwan

📍 Bangkok, Thailand

📍 Hat Yai, Thailand

📍 Muang, Thailand

📍 Ratchathewi, Thailand

📍 Ankara, Turkey

📍 Istanbul, Turkey

📍 Izmir, Turkey

📍 Kahramanmaras, Turkey

📍 Kayseri, Turkey

📍 Kocaeli, Turkey

📍 Ha Noi, Vietnam

📍 Hanoi, Vietnam

📍 Ho Chi Minh, Vietnam

📍 Hochiminh, Vietnam

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Active proliferative LN Class III or IV either with or without the presence of Class V according to the 2003 ISN/RPS classification
2. Renal biopsy obtained within 6 months prior to signing the ICF or during Screening Period.
3. Urine protein to creatinine ratio \> 1 mg/mg (113.17 mg/mmol)
4. eGFR ≥ 35 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
5. Fulfills updated 2019 EULAR/ACR SLE classification criteria.
6. No signs of symptoms of active TB prior to or during screening or no treatment for latent TB

Exclusion Criteria:

1. A diagnosis of pure Class V LN based on the renal biopsy obtained within 6 months prior to signing the ICF or during Screening.
2. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV confirmed by the central lab at Screening - an HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1).
3. Evidence of hepatitis C or active hepatitis B.
4. Any history of cancer except sucessfully cured skin squamos or basal skin carcinoma and cervical cancer in situ.
5. Receipt of the following for the current LN flare (ie, since the qualifying renal biopsy): IV cyclophosphamide \> 2 pulses of high-dose (≥ 0.5 g/m2) or \> 4 doses of low dose (500 mg every 2 weeks) or Average MMF \> 2.5 g/day (or \> 1800 mg/day of enteric coated mycophenolate sodium) for more than 8 weeks or Tacrolimus \> 4 mg/day for more than 8 weeks; Cyclosporine for more than 8 weeks or during last 8 weeks prior to signing the ICF; Voclosporin for more than 8 weeks or during last 8 weeks prior to signing the ICF; Belimumab for more than 12 weeks or during last 12 weeks prior the ICF.
6. Previous receipt of \>◦2 investigation treatments (other than anifrolumab) for LN or SLE since time of diagnosis and through the ICF.
7. Known intolerance to ≤ 1.0 g/day of MMF.
8. Any history of severe COVID-19 infection.

Ages Eligible for Study: 18 Years to 70 Years (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 17 November 2021
First Submitted that Met QC Criteria 17 November 2021
First Posted 30 November 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 15 July 2024
Last Update Posted 16 July 2024
Last Verified July 2024