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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05138133
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AstraZeneca
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Belgium, Brazil, Bulgaria, China, Colombia, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Puerto Rico, Russia, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Nephritis

Additional Details

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.

Arms & Interventions

Arms

Experimental: Anifrolumab

Solution for intravenous infusion

Placebo Comparator: Placebo

Solution for intravenous infusion

Interventions

Drug: - Anifrolumab

Anifrolumab intravenous infusion (IV)

Drug: - Placebo

Placebo intravenous infusion (IV)

Contact a Trial Team

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Research Site, Birmingham 4049979, Alabama 4829764

Status

Withdrawn

Address

Research Site

Birmingham 4049979, Alabama 4829764, 35233

Site Contact

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