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History of Changes for Study: NCT02794285
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)
Latest version (submitted January 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2016 None (earliest Version on record)
2 June 24, 2016 Outcome Measures, Contacts/Locations and Study Status
3 July 14, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 August 12, 2016 Study Status and Contacts/Locations
5 September 5, 2016 Study Status and Study Identification
6 September 30, 2016 Contacts/Locations, Study Status and Study Identification
7 November 2, 2016 Contacts/Locations and Study Status
8 November 29, 2016 Contacts/Locations and Study Status
9 January 5, 2017 Contacts/Locations and Study Status
10 February 3, 2017 Contacts/Locations and Study Status
11 March 10, 2017 Study Status and Contacts/Locations
12 April 11, 2017 Contacts/Locations and Study Status
13 May 16, 2017 Contacts/Locations and Study Status
14 June 20, 2017 Study Status and Contacts/Locations
15 July 20, 2017 Contacts/Locations and Study Status
16 August 22, 2017 Contacts/Locations, Study Status and Eligibility
17 September 28, 2017 Study Status and Contacts/Locations
18 October 31, 2017 Contacts/Locations and Study Status
19 December 5, 2017 Contacts/Locations and Study Status
20 January 5, 2018 Contacts/Locations and Study Status
21 February 5, 2018 Contacts/Locations, Study Status and Study Identification
22 March 12, 2018 Contacts/Locations and Study Status
23 April 11, 2018 Study Status and Contacts/Locations
24 May 10, 2018 Study Status and Contacts/Locations
25 June 11, 2018 Contacts/Locations and Study Status
26 July 5, 2018 Study Status, Contacts/Locations and Study Design
27 August 1, 2018 Contacts/Locations, Study Design and Study Status
28 September 4, 2018 Contacts/Locations and Study Status
29 October 9, 2018 Contacts/Locations, Eligibility and Study Status
30 October 12, 2018 Study Status
31 November 6, 2018 Contacts/Locations and Study Status
32 November 15, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
33 February 14, 2019 Study Status, Contacts/Locations and Study Design
34 May 16, 2019 Study Status, Contacts/Locations and Study Design
35 August 9, 2019 Study Status
36 November 7, 2019 Study Status and Contacts/Locations
37 February 9, 2020 Contacts/Locations and Study Status
38 May 18, 2020 Study Status and Contacts/Locations
39 August 11, 2020 Study Status
40 November 16, 2020 Study Status
41 February 16, 2021 Study Status and Contacts/Locations
42 May 10, 2021 Contacts/Locations and Study Status
43 August 13, 2021 Contacts/Locations and Study Status
44 November 17, 2021 Study Status
45 January 23, 2022 Recruitment Status and Study Status
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Study NCT02794285
Submitted Date:  June 6, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: D3461C00009
Brief Title: Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus (TULIP SLE LTE)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Not yet recruiting
Study Start: July 2016
Primary Completion: June 2021 [Anticipated]
Study Completion: June 2021 [Anticipated]
First Submitted: June 6, 2016
First Submitted that
Met QC Criteria:
June 6, 2016
First Posted: June 9, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 6, 2016
Last Update Posted: June 9, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators: PRA Health Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
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.
Open or close this module Conditions
Conditions: Active Systemic Lupus Erythematosus
Keywords: Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 575 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To characterise the long-term safety and tolerability of IV anifrolumab
[ Time Frame: Week 208 ]

Rates of Adverse events of special interest and Serious Adverse Events
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
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. 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) 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/mycophenolic acid >2.0 g/day
    3. Oral, subcutaneous, or intramuscular methotrexate >25 mg/week
  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 (LLOQ) as per the central laboratory.
  7. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Study Officials: Kenneth Kalunian, MD
Principal Investigator
University of California, San Diego
Raj Tummala, MD
Study Director
AstraZeneca
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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