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Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

NCT02446912•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Detailed Description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. The study will be performed in adult subjects aged 18 to 70 years of age.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 through 70 years at the time of screening
•2. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982 revised criteria ≥24 weeks prior to signing the Informed Consent form (ICF)
•3. Currently receiving at least 1 of the following:
•1. Where prednisone is the single standard of care medication (ie, the subject is not concurrently receiving any medication listed in inclusion criterion 3(c)), a dose of oral prednisone ≥7.5 mg/day but ≤40 mg/day (or prednisone equivalent) for a minimum of 8 weeks prior to Day 1. In addition, the dose of oral prednisone or prednisone equivalent the subject is taking must be stable for a minimum of 2 weeks prior to randomisation.
•2. Where prednisone is not the single standard of care medication (ie, the subject is concurrently receiving at least one medication listed in inclusion criterion 3(c)), a dose of oral prednisone (≤40 mg/day) (or prednisone equivalent) for a minimum of 2 weeks prior to signing of the ICF. In addition, the dose of oral prednisone or prednisone equivalent the subject is taking must be stable for a minimum of 2 weeks prior to randomisation.
•3. Any of the following medications administered for a minimum of 12 weeks prior to signing the informed consent, and at a stable dose for a minimum of 8 weeks prior to signing the informed consent through Day 1:
•(i) Azathioprine ≤200 mg/day (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day
•4. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for SLE, at least 1 of which must be:
•1. Positive antinuclear antibody (ANA) test at screening by immunofluorescent assay (IFA) at the central laboratory with titre ≥1:80; OR
•2. Anti-dsDNA antibodies at screening elevated to above normal (including indeterminante), as per the central laboratory; OR
+8 more criteria

Exclusion Criteria

•1. Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
•2. Receipt of any of the following:
•(a) Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to Day 1
•3. History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome.
•4. Active severe or unstable neuropsychiatric SLE
•5. Active severe SLE-driven renal disease
•6. Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any history of overlap syndromes of SLE or SSc.
•7. History of, or current, inflammatory joint or skin disease other than SLE
•8. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 24 weeks prior to signing the ICF
•9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation
+6 more criteria

Locations (145)

Research Site

Birmingham, Alabama, United States

Research Site

El Cajon, California, United States

Research Site

La Jolla, California, United States

Research Site

Los Alamitos, California, United States

Research Site

Thousand Oaks, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Aventura, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Orlando, Florida, United States

Key Dates

Start Date

June 9, 2015

Primary Completion Date

July 17, 2018

Completion Date

July 17, 2018

Last Updated

January 12, 2023

Enrollment

460

ACTUAL participants

Conditions

Active Systemic Lupus Erythematosus

Interventions

Anifrolumab

BIOLOGICAL

Placebo

DRUG

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)

NCT07311200

Active Systemic Lupus Erythematosus

View study

COMPLETED

Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus

NCT06485674

Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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