Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy

Official Title

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Details

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age.

Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52. Subjects who complete Week 52 may enter into open-label extension (OLE). All patients who enter the OLE Period will receive a fixed subcutaneous dose of anifrolumab for up to 52 weeks. Study intervention will be administered SC via an accessorised prefilled syringe (aPFS).

Keywords

Systemic Lupus Erythematosus, Systemic Lupus Erythematosuss Anifrolumab, Adult patients, BICLA, glucocorticoids, Immunosuppressant(s), sub-cutaneous, Medi-546, Anifrolumab

Eligibility

You can join if…

Open to people ages 18-70

  1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
  2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
  3. BILAG2004 with at least 1 of the following:
    1. BILAG2004 level A disease in ≥ 1 organ system
    2. BILAG2004 level B disease in ≥ 2 organ systems
  4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
  5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
  6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

You CAN'T join if...

  1. Active severe or unstable neuropsychiatric SLE
  2. Active severe SLE-driven renal disease
  3. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.

    10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or

    more of the same type of infection over the previous 52 weeks).

    11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition

    that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.

    12. At Screening, confirmed positive test for hepatitis B serology and positive test for

    hepatitis C antibody

    13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1), 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within

    3 years of randomization.

    15. History of cancer, apart from:

    1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
    2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site accepting new patients
    Upland California 91786 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
Sign up for this study
ID
NCT04877691
Phase
Phase 3 Lupus Research Study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated