Systemic Lupus Erythematosus
Conditions
Interventions
Product Name: Anifrolumab
Product Code: MEDI-546
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 through 70 years 2. Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling =4 of the 11 ACR classification criteria with at least one being: -Positive antinuclear antibody (ANA) or -Elevated anti-dsDNA antibodies or -anti-Smith (anti-Sm) antibodies 3. Interferon high test result 4. CLASI activity score = 10 5. 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 ICFand with stable dosefor 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 6. Must not have signs of active or latent TB. 7. Must not be pregnant or breastfeeding Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Active severe or unstable neuropsychiatric SLE 2. Active severe SLE-driven renal disease 3. Any severe herpes infection at any time 4. HBV, HCV, or HIV infection. 5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection 6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF 7. History of cancer, apart from: - Squamous or basal cell carcinoma of the skin if successfully treated - Cervical cancer in situ if successfully treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the pharmacokinetics and pharmacodynamics of anifrolumab.; Secondary Objective: 1. To characterize the safety and tolerability anifrolumab 2. To characterize the immunogenicity of anifrolumab ; Primary end point(s): • Anifrolumab concentration and PK parameters, e.g., maximum concentration (Cmax) after first IP dose and trough concentration (Ctrough) after subsequent dosing. Additional PK parameters may be determined where appropriate. • 21-gene type I IFN signature score and neutralization ratio (relative to baseline) ;Timepoint(s) of evaluation of this end point: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability variables including: • Adverse events (AEs) and serious adverse events (SAEs) • Adverse events of special interest (AESIs) including herpes zoster, influenza, opportunistic infections, tuberculosis (TB), malignancies, non-SLE related vasculitis, anaphylaxis, and major adverse cardiovascular events (MACE) • Laboratory variables • Physical examinations • Vital signs • ECG Immunogenicity as assessed by measurement of anti-drug antibodies (ADA). ;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Hungary, Korea, Republic of, Poland, United States
Contacts
Public ContactClinical Trial Transparency
AstraZeneca
Outcome results
None listed