Status and phase
Conditions
Treatments
About
This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18 through 70 years
Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:
Interferon high test result
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10
Currently receiving at least 1 of the following for treatment of SLE:
• Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization
• Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (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
Must not have signs of active or latent tuberculosis (TB).
Must not be pregnant or breastfeeding.
Exclusion criteria
Active severe or unstable neuropsychiatric SLE
Active severe SLE-driven renal disease
Any severe herpes infection at any time
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.
Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection
Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF
History of cancer, apart from:
Primary purpose
Allocation
Interventional model
Masking
36 participants in 4 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal