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A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

IRB Number: 2015-777

February 08, 2017

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Kyriakos A. Kirou, MD

Co-Investigators

David R. Fernandez, MD, PhD
Kerri Merritt
 

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an IV treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active, SLE while receiving standard of care (SOC) treatment. 360 subjects will be randomized in a 1:1 ratio to receive a fixed intravenous dose of anifrolumab or placebo every 4 weeks for a total of 13 doses, with the primary endpoint evaluated at the Week 52 visit.

Inclusion/Exclusion Criteria

Some CAN participate in this study if they:

  1. are capable of providing written consent to participate in the study
  2. are at least 18 years old and less than 70 years old
  3. are diagnosed with Systemic Lupus Erythematosus (SLE)
  4. have a positive ANA test, elevated anti-double stranded DNA antibodies, or positive anti-smith antibody at time of screening
  5. are currently receiving at least 1 of the following
    1. a dose of oral prednisone (≤40 mg/day) for a minimum of 2 weeks prior to signing informed consent form
    2. any of the following mediations for a minimum of 12 weeks prior to signing the informed consent form
      1. Azathioprine ≤200 mg/day
      2. Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
      3. Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
      4. Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week
      5. Mizoribine ≤150 mg/day
  6. have active disease at time of enrollment
  7. agree to practice at least 2 approved methods of contraception

 

Someone CANNOT participate in this study if they:

  1. currently pregnant, breastfeeding, or planning on becoming pregnant
  2. currently taking/have received rituximab in past 26 weeks
  3. currently taking/have received belimumab in past 12 weeks
  4. currently taking/have received cyclophosphamide in past 24 weeks
  5. have a known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy
  6. receipt of any of the following:
    1. any live or attenuated vaccine within 8 weeks prior to signing the informed consent form
    2. receive the Bacillus Calmette-Guerin (BCG) vaccine within 1 year of signing the informed consent form
    3. receive a blood transfusion within 4 weeks prior to signing the informed consent form
  7. have a history of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome, have an overlap autoimmune disease with SLE, or have CAPS (catastrophic antiphospholipid syndrome)
  8. have a history of primary immunodeficiency and major infections
  9. have a 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)

Contact Information

Kerri Merritt, Research Coordinator
merrittk@hss.edu
212.774.2967