Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
TULIP-LN1
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
1 other identifier
interventional
147
17 countries
80
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2015
Longer than P75 for phase_2
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedStudy Start
First participant enrolled
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2021
CompletedResults Posted
Study results publicly available
November 24, 2021
CompletedNovember 24, 2021
October 1, 2021
4.1 years
August 31, 2015
September 7, 2021
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (UPCR)
To evaluate the efficacy of anifrolumab plus SOC (combination of mycophenolate mofetil and corticosteroids) compared with placebo plus SOC in subjects with active proliferative lupus nephritis (LN). Geometric mean ratio of 24-hour UPCR at week 52 over baseline. Values \<1 indicate improvement from baseline.
From Week 1 (Baseline) up to Week 52
Secondary Outcomes (1)
Proportion of Subjects Achieving the Composite Endpoint Complete Renal Response (CRR)
Week 52
Other Outcomes (4)
Number of Subjects With Adverse Events
From screening (Day-30 to -1) period until the follow-up period (Week 112)
Number of Subjects With Suicidal Ideation and Behavior and Suicide Attempts Via Columbia-Suicide Severity Rating Scale (C-SSRS)
Baseline, treatment and follow up (an average of 60 weeks)
Total Score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Baseline, Week 12, Week 24, Week 36, Week 52, Week 60
- +1 more other outcomes
Study Arms (3)
Anifrolumab - Lower Dose
EXPERIMENTALAnifrolumab - Lower Dose
Anifrolumab - Higher Dose
EXPERIMENTALAnifrolumab - Higher Dose
Placebo
PLACEBO COMPARATORPlacebo IV Q4W plus SOC
Interventions
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Eligibility Criteria
You may qualify if:
- Age 18 through 70 years at the time of screening
- Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
- Positive antinuclear antibody (ANA) test (1:40 or higher) or
- Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or
- Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
- 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:
- Urine protein to creatinine ratio \>1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening
- Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
- Must not have active or latent TB on either chest radiograph or by Quantiferon gold test
- 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.
You may not qualify if:
- 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
- Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
- Known intolerance to ≤1.0 gm/day of MMF
- 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
- Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
- Oral corticosteroids \>0.5 mg/kg/day for more than 8 weeks or
- Oral or IV pulse methylprednisolone \>3.0 gm (cumulative dose) or
- IV cyclophosphamide \>2 pulses of high-dose (≥0.5 gm/m2) or \>4 doses of low dose (500 mg every 2 weeks) or
- Average MMF \>2.5 gm/day (\>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
- Tacrolimus \>4 mg/day for more than 8 weeks
- Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
- 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
- Confirmed positive test for hepatitis B or hepatitis C
- Any severe herpes infection at any time prior to randomization
- History of cancer, apart from:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (80)
Research Site
Glendale, Arizona, 85306, United States
Research Site
Phoenix, Arizona, 85032, United States
Research Site
La Jolla, California, 92037-0706, United States
Research Site
Los Angeles, California, 90095-1670, United States
Research Site
Thousand Oaks, California, 91360, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
DeBary, Florida, 32713, United States
Research Site
Boston, Massachusetts, 02118, United States
Research Site
Newark, New Jersey, 07103-2499, United States
Research Site
Great Neck, New York, 11021, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
New York, New York, 10016, United States
Research Site
New York, New York, 10029, United States
Research Site
The Bronx, New York, 10457, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Buenos Aires, C1015ABO, Argentina
Research Site
Córdoba, 5016, Argentina
Research Site
Rosario, S2000PBJ, Argentina
Research Site
Adelaide, 5000, Australia
Research Site
Clayton, VIC 3168, Australia
Research Site
Parkville, 3050, Australia
Research Site
Westmead, 2145, Australia
Research Site
Brussels, 1070, Belgium
Research Site
Brussels, 1200, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, B-4000, Belgium
Research Site
Bordeaux, 33076, France
Research Site
Marseille, 13005, France
Research Site
Paris, 75013, France
Research Site
Strasbourg, 67098, France
Research Site
Toulouse, 31059, France
Research Site
Berlin, 10117, Germany
Research Site
Kiel, 24105, Germany
Research Site
Budapest, 1097, Hungary
Research Site
Debrecen, 4032, Hungary
Research Site
Kaposvár, 7400, Hungary
Research Site
Szeged, 6725, Hungary
Research Site
Milan, 20132, Italy
Research Site
Padua, 35128, Italy
Research Site
Pisa, 56126, Italy
Research Site
Reggio Emilia, 42100, Italy
Research Site
Chihuahua City, 31000, Mexico
Research Site
Guadalajara, 44160, Mexico
Research Site
Guadalajara, 44280, Mexico
Research Site
México, 14080, Mexico
Research Site
San Luis Potosí City, 78213, Mexico
Research Site
Arequipa, AREQUIPA54, Peru
Research Site
Lima, L14, Peru
Research Site
Lima, L34, Peru
Research Site
Lima, LIMA 01, Peru
Research Site
Lima, LIMA 31, Peru
Research Site
Lima, LIMA 32, Peru
Research Site
Lima, LIMA 33, Peru
Research Site
Lima, Lima-1, Peru
Research Site
Lima, Peru
Research Site
Krakow, 31-066, Poland
Research Site
Lodz, 92-213, Poland
Research Site
Warsaw, 02-637, Poland
Research Site
Orenburg, 460018, Russia
Research Site
Saint Petersburg, 197022, Russia
Research Site
Saint Petersburg, 197089, Russia
Research Site
Belgrade, 11000, Serbia
Research Site
Belgrade, 1100, Serbia
Research Site
Niš, 18000, Serbia
Research Site
Novi Sad, 21000, Serbia
Research Site
Gwangju, 501-757, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 150-713, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
Changhua, 50006, Taiwan
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
London, E1 1BB, United Kingdom
Related Publications (2)
Jayne D, Rovin B, Mysler E, Furie R, Houssiau F, Trasieva T, Knagenhjelm J, Schwetje E, Tang W, Tummala R, Lindholm C. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023 Aug;10(2):e000910. doi: 10.1136/lupus-2023-000910.
PMID: 37607780DERIVEDJayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.
PMID: 35144924DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical study Information Center
Study Officials
- STUDY DIRECTOR
AstraZeneca AB
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 14, 2015
Study Start
November 4, 2015
Primary Completion
November 26, 2019
Study Completion
January 18, 2021
Last Updated
November 24, 2021
Results First Posted
November 24, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
- Access Criteria
- 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.
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: