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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by AstraZeneca
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02794285
First received: June 6, 2016
Last updated: August 22, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Condition Intervention Phase
Active Systemic Lupus Erythematosus Biological: Anifrolumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To measure the long-term safety and tolerability of IV anifrolumab by measuring the rates of adverse events of special interest and serious adverse events [ Time Frame: Week 208 ]
    Rates of Adverse events of special interest and serious adverse events using incidence rates (ie number of events divided by person-time at risk)


Estimated Enrollment: 575
Actual Study Start Date: June 30, 2016
Estimated Study Completion Date: June 14, 2021
Estimated Primary Completion Date: June 14, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02794285

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 271 Study Locations
Sponsors and Collaborators
AstraZeneca
PRA Health Sciences
Investigators
Principal Investigator: Kenneth Kalunian, MD University of California, San Diego
Study Director: Raj Tummala, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02794285     History of Changes
Other Study ID Numbers: D3461C00009
Study First Received: June 6, 2016
Last Updated: August 22, 2017

Keywords provided by AstraZeneca:
Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017