A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

Plain-language summary

This study examines the behaviour in the body and the safety of the drug Anifrolumab compared with placebo in patients with systemic lupus erythematosus who have a high type I interferon test and active skin manifestations. It enrolled adults aged 18-70 who had been diagnosed with SLE for at least 24 weeks and had a high interferon level and skin involvement. It was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

AstraZeneca

Intervention

Anifrolumab, Placebo

Start date

2/14/2017

Estimated completion

12/17/2018

Countries

United States, Hungary, Poland, South Korea

Related genes

Locations

• Thousand Oaks, United States
• Orlando, United States
• New York, United States
• Charlotte, United States
• Memphis, United States
• Houston, United States
• Debrecen, Hungary
• Zalaegerszeg, Hungary
• Bydgoszcz, Poland
• Warsaw, Poland
• Anyang-si, South Korea
• Busan, South Korea
• Daegu, South Korea
• Gwangju, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Age 18 through 70 years
2. 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:

   * Positive antinuclear antibody (ANA) or
   * Elevated anti-dsDNA antibodies or
   * anti-Smith (anti-Sm) antibodies
3. Interferon high test result
4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (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 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
6. Must not have signs of active or latent tuberculosis (TB).
7. Must not be pregnant or breastfeeding.

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. Hepatitis B Virus (HBV), Hepatitis C Virus (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