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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 is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02962960
First Posted: November 15, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Anifrolumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The maximum concentration (Cmax) of anifrolumab in serum after two fixed doses administration [ Time Frame: At week 0 ]
    To assess the Cmax measured after the first dose of anifrolumab.

  • The steady-state serum trough (predose) concentration (Ctrough) of anifrolumab in serum after two fixed doses administration [ Time Frame: At week 12 ]
    To assess the Ctrough after subsequent dosing anifrolumab at week 12

  • 21-gene type I IFN signature score in subjects receiving two fixed doses of anifrolumab [ Time Frame: At week 12 ]
    To be used as a PD marker to follow the biologic effect of anifrolumab.

  • 21-gene type I IFN neutralization ratio in subjects receiving two fixed doses of anifrolumab [ Time Frame: At week 12 ]
    To characterize PD profile.


Secondary Outcome Measures:
  • antidrug antibody (ADA) [ Time Frame: Up until study end at week 60 ]
    To characterize Immunogenicity of anifrolumab(two fixed doses).

  • neutralizing antibodies (nAb) [ Time Frame: Up until study end at week 60 ]
    To characterize Immunogenicity of anifrolumab(two fixed doses), Neutralising antibodies testing will only occur on samples that are ADA positive.

  • Number of AEs (Adverse events) and SAEs (serious adverse events), including adverse events of special interest (AESI) [ Time Frame: Up until study end at week 60 ]
    To assess the safety and tolerability profile in terms of events, event rates, and number of subjects experiencing AEs, SAEs and AESIs.

  • Change from baseline for vital signs [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile in terms of assessment of vital signs.

  • Change from baseline for physical examination [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile in terms of assessment of physical examination.

  • Change from baseline for 12-lead ECG [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile in terms of assessment of 12-lead ECG.

  • Value of Haematology blood tests to detect change from baseline [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.

  • Value of Urinalysis tests to detect change from baseline [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.

  • Value of Clinical Chemistry blood tests to detect change from baseline (serum) [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.

  • Value of Inflammatory marker panel blood tests to detect change from baseline [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.

  • Value of Autoantibody blood panel blood tests to detect change from baseline [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.

  • Value of Infection-related blood tests to detect change from baseline [ Time Frame: Up until study end at week 60 ]
    To assess the safety profile, and all tests will be performed in a central clinical laboratory.


Enrollment: 36
Actual Study Start Date: February 14, 2017
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anifrolumab - Lower dose
1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
Drug: Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
Placebo Comparator: Placebo matching for lower dose of Anifrolumab
1ml, once every second week, one subcutaneous injection added to stand of care, from week 0 to week 50
Drug: Placebo
subcutaneous administration every two weeks from week 0 to week 50
Experimental: Anifrolumab - Higher dose
2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
Drug: Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
Placebo Comparator: Placebo matching for higher dose of Anifrolumab
2×1ml , once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
Drug: Placebo
subcutaneous administration every two weeks from week 0 to week 50

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962960


Locations
United States, California
Research Site
Thousand Oaks, California, United States, 91360
United States, Florida
Research Site
Orlando, Florida, United States, 32810
United States, New York
Research Site
New York, New York, United States, 10019
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
Houston, Texas, United States, 77034
Hungary
Research Site
Debrecen, Hungary, 4032
Research Site
Zalaegerszeg, Hungary, 8900
Korea, Republic of
Research Site
Anyang-si, Korea, Republic of, 14068
Research Site
Busan, Korea, Republic of, 49241
Research Site
Daegu, Korea, Republic of, 41944
Research Site
Gwangju, Korea, Republic of, 61469
Poland
Research Site
Bydgoszcz, Poland, 85-168
Research Site
Warszawa, Poland, 00-660
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02962960     History of Changes
Other Study ID Numbers: D3461C00008
First Submitted: September 23, 2016
First Posted: November 15, 2016
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Skin Manifestations
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Interferons
Interferon Type I
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents