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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02547922




Registration number
NCT02547922
Ethics application status
Date submitted
31/08/2015
Date registered
14/09/2015

Titles & IDs
Public title
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
Scientific title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis
Secondary ID [1] 0 0
D3461C00007
Universal Trial Number (UTN)
Trial acronym
TULIP-LN1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Anifrolumab
Treatment: Drugs - Placebo

Experimental: Anifrolumab - Lower Dose - Anifrolumab - Lower Dose

Experimental: Anifrolumab - Higher Dose - Anifrolumab - Higher Dose

Placebo comparator: Placebo - Placebo IV Q4W plus SOC


Treatment: Other: Anifrolumab
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112

Treatment: Drugs: Placebo
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
Timepoint [1] 0 0
From Week 1 (Baseline) up to Week 52
Secondary outcome [1] 0 0
Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
Timepoint [1] 0 0
Week 52

Eligibility
Key inclusion criteria
Main

1. Age 18 through 70 years at the time of screening
2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:

1. Positive antinuclear antibody (ANA) test (1:40 or higher) or
2. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or
3. Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
3. Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period:
4. Urine protein to creatinine ratio >1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening
5. Estimated glomerular filtration rate =35 mL/min/1.73 m2
6. Must not have active or latent TB on either chest radiograph or by Quantiferon gold test
7. Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to the first dose of sponsor-provided MMF.

Main
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of any investigational product (small molecule or biologic) or commercially available biologic agent within four weeks or 5 half lives prior to signing of the ICF, whichever is greater
2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
3. Known intolerance to =1.0 gm/day of MMF
4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment
5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy

1. Oral corticosteroids >0.5 mg/kg/day for more than 8 weeks or
2. Oral or IV pulse methylprednisolone >3.0 gm (cumulative dose) or
3. IV cyclophosphamide >2 pulses of high-dose (=0.5 gm/m2) or >4 doses of low dose (500 mg every 2 weeks) or
4. Average MMF >2.5 gm/day (>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
5. Tacrolimus >4 mg/day for more than 8 weeks
6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
8. Confirmed positive test for hepatitis B or hepatitis C
9. Any severe herpes infection at any time prior to randomization
10. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason).
11. History of cancer, apart from:

1. Squamous or basal cell carcinoma of the skin that has been successfully treated
2. Cervical cancer in situ that has been successfully treated
12. Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is longer.
13. During screening (within 30 days before Day 1 [Week 0 visit]), any of the following:

1. Aspartate transaminase (AST) >2.5×upper limit of normal (ULN)
2. Alanine transaminase (ALT) >2.5×ULN
3. Total bilirubin >ULN (unless due to Gilbert's syndrome [based on Investigator's judgement])
4. Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic subjects only)
5. Neutrophil count <1x103/µL (or <1.0 GI/L)
6. Platelet count <25x103/µL (or <25 GI/L)
7. Haemoglobin <8 g/dL (or <80 g/L).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2021
Sample size
Target
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment hospital [4] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Tennessee
Country [11] 0 0
Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Rosario
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Liege
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France
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Bordeaux Cedex
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France
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Marseille
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France
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Paris Cedex 14
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France
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Strasbourg
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France
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Toulouse
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Germany
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Berlin
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Germany
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Kiel
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvár
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Hungary
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Szeged
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Italy
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Milano
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Italy
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Padova
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Italy
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Pisa
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Italy
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Reggio Emilia
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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Mexico
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Chihuahua
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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San Luis Potosí
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Krakow
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Poland
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Warszawa
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Poland
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Lódz
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Russian Federation
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Orenburg
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Russian Federation
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Saint Petersburg
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Serbia
State/province [47] 0 0
Belgrade
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Serbia
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Nis
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Serbia
State/province [49] 0 0
Novi Sad
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Spain
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Barcelona
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Taiwan
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Changhua City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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United Kingdom
State/province [56] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca AB
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02547922