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Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)

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.
 
ClinicalTrials.gov Identifier: NCT02794285
Recruitment Status : Completed
First Posted : June 9, 2016
Results First Posted : January 13, 2023
Last Update Posted : January 13, 2023
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Condition or disease Intervention/treatment Phase
Active Systemic Lupus Erythematosus Biological: Anifrolumab Drug: Placebo Phase 3

Detailed Description:
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : December 21, 2021
Actual Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Anifrolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anifrolumab
Anifrolumab
 Biological: Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses


Outcome Measures
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Primary Outcome Measures :
  1. Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to a maximum of 1114 days ]

    The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years.

    The following AESIs were pre-defined:

    • Non-opportunistic serious infections
    • Opportunistic infections
    • Anaphylaxis
    • Malignancy
    • Herpes zoster
    • Tuberculosis (TB) (including latent TB)
    • Influenza
    • Vasculitis (non-systemic lupus erythematosus [SLE])
    • Major cardiovascular events as according to the Cardiovascular Event Adjudication Committee.

  2. EAIRs of Serious Adverse Events (SAEs) [ Time Frame: Up to a maximum of 1114 days ]

    EAIRs of SAEs are presented as event rate per 100 participant years.

    An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria:

    • Results in death
    • Is immediately life-threatening
    • Requires in-patient hospitalisation or prolongation of existing hospitalisation
    • Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
    • Is a congenital abnormality or birth defect
    • Is an important medical event that may jeopardise the participant or may require medical intervention to prevent one of the outcomes listed above.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
  2. Adequate peripheral venous access
  3. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.

  4. Meets the following TB criteria:

    1. Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
    2. Newly positive QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must start on prophylaxis within 30 days of randomisation but prior to the second dose of investigational product (Visit 2/Week 4); OR
    3. Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005. The subject must have been diagnosed with latent TB and must have documentation confirming initiation of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
    4. Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
  5. In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments

Exclusion Criteria:

  1. Receipt of any of the following within the last 60 days:

    1. Azathioprine >200 mg/day
    2. Mycophenolate mofetil >2.0 g/day /mycophenolic acid >1.44 g/day
    3. Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
    4. Mizoribine >150 mg/day
  2. Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater

  3. Receipt of any of the following:

    1. Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)
    2. Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
  4. Active severe SLE-driven renal or neuropsychiatric disease
  5. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
  6. Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
  7. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Contacts and Locations
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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): NCT02794285


Locations
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Sponsors and Collaborators
AstraZeneca
PRA Health Sciences
Investigators
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Principal Investigator: Kenneth Kalunian, MD University of California, San Diego
Study Director: Raj Tummala, MD AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] August 10, 2017
Statistical Analysis Plan  [PDF] April 25, 2022

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02794285    
Other Study ID Numbers: D3461C00009
First Posted: June 9, 2016    Key Record Dates
Results First Posted: January 13, 2023
Last Update Posted: January 13, 2023
Last Verified: December 2022
Keywords provided by AstraZeneca:
Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases