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Completed

NCT Number: NCT02962960

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Debrecen, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Positive antinuclear antibody (ANA) or
  • Elevated anti-dsDNA antibodies or
  • anti-Smith (anti-Sm) antibodies
  • 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:
  • Squamous or basal cell carcinoma of the skin if successfully treated.
  • Cervical cancer in situ if successfully treated

Treatment and study plan

Anifrolumab

Drug

subcutaneous administration every 2 weeks from week 0 to week 50

Placebo

Drug

subcutaneous administration every two weeks from week 0 to week 50

Primary outcomes

  1. Maximum Concentration of Anifrolumab in Serum After First Dose

    Time frame: Week 0

    Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.

  2. Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab

    Time frame: Week 12

    Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).

  3. 21-gene Type 1 IFN Signature Score (Fold-change)

    Time frame: Week 12

    21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.

  4. 21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)

    Time frame: Week 12

    21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes. At a population level, the results are presented as mean the above.

Secondary outcomes

  1. Number of Participants With Antidrug Antibody (ADA)

    Time frame: Baseline to Week 52

    Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)

  2. Number of Participants With Neutralizing Antibodies (nAb)

    Time frame: Baseline to Week 52

    Incidence of detectable nAb in post-baseline ADA positive participants.

  3. Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)

    Time frame: Baseline to Week 52

    Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.

  4. Change From Baseline for Vital Signs

    Time frame: Baseline to Week 60

    Change from baseline for vital signs.

  5. Change From Baseline for Physical Examination

    Time frame: Baseline to Week 60

    Physical examination is reported as change from baseline in body weight.

  6. Change From Baseline for 12-lead ECG

    Time frame: Baseline to Week 52

    The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done.

  7. Value of Haemoglobin Blood Test to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in haemoglobin blood tests are reported.

  8. Value of Haematology Blood Tests to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in haematology blood tests (leucocytes [particle concentration], platelets [particle concentration]) are reported.

  9. Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in protein-creatinine ratio urinalysis tests are reported.

  10. Value of Total Protein Urinalysis Test to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in total protein urinalysis tests are reported.

  11. Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)

    Time frame: Baseline to Week 60

    Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.

  12. Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)

    Time frame: Baseline to Week 60

    Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.

  13. Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.

  14. Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline

    Time frame: Baseline to Week 60

    Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.

  15. Number of Participants With Positive Hepatitis B Core Antibody Post-baseline.

    Time frame: Baseline to Week 60

    Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2016
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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