Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Tulip SC
A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
3 other identifiers
interventional
367
15 countries
140
Brief Summary
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
Longer than P75 for phase_3
140 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
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
June 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2026
ExpectedApril 17, 2026
April 1, 2026
4.2 years
May 4, 2021
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria: * Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D and no BILAG-2004 worsening in other organ systems, where worsening is defined as ≥ 1 new BILAG-2004 A or ≥ 2 new BILAG 2004 B. * No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of \> 0 points in SLEDAI-2K. * No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point PGA VAS.
At week 52
Secondary Outcomes (6)
Time to first BICLA response sustained through Week 52
Baseline through to Week 52
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
At week 52
Time to flare
Baseline through to Week 52
Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.
At week 52
Annualized flare rate
Baseline through to Week 52
- +1 more secondary outcomes
Other Outcomes (1)
Adverse Event Overview
Up to 2 years 4 months
Study Arms (2)
Anifrolumab
EXPERIMENTALSolution for injection in aPFS
Placebo
PLACEBO COMPARATORSolution for injection in aPFS
Interventions
Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.
Eligibility Criteria
You may qualify if:
- Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
- To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
- BILAG2004 with at least 1 of the following:
- BILAG2004 level A disease in ≥ 1 organ system
- BILAG2004 level B disease in ≥ 2 organ systems
- Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
- Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
- Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.
You may not qualify if:
- Active severe or unstable neuropsychiatric SLE
- Active severe SLE-driven renal disease
- 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.
- History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
- Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
- At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
- Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
- History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
- Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IQVIA Pty Ltdcollaborator
- AstraZenecalead
Study Sites (140)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Paradise Valley, Arizona, 85253, United States
Research Site
Phoenix, Arizona, 85032, United States
Research Site
El Cajon, California, 92020, United States
Research Site
Fullerton, California, 92835, United States
Research Site
Hemet, California, 92543, United States
Research Site
La Mesa, California, 91942, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Menifee, California, 92586, United States
Research Site
Upland, California, 91786, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Brandon, Florida, 33511, United States
Research Site
Clearwater, Florida, 33759, United States
Research Site
Clearwater, Florida, 33765, United States
Research Site
Miami, Florida, 33180, United States
Research Site
Tampa, Florida, 33613, United States
Research Site
Tampa, Florida, 33614, United States
Research Site
Idaho Falls, Idaho, 83404, United States
Research Site
Flint, Michigan, 48504, United States
Research Site
Lansing, Michigan, 48911, United States
Research Site
Newark, New Jersey, 07103, United States
Research Site
Las Cruces, New Mexico, 88011, United States
Research Site
Brooklyn, New York, 11201, United States
Research Site
Manhasset, New York, 11030, United States
Research Site
New York, New York, 10032, United States
Research Site
Potsdam, New York, 13676, United States
Research Site
Charlotte, North Carolina, 28203, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Pittsburgh, Pennsylvania, 15224, United States
Research Site
Reading, Pennsylvania, 19610, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Grapevine, Texas, 76051, United States
Research Site
Ciudad de Buenos Aires, C1431FWO, Argentina
Research Site
La Plata, 1900, Argentina
Research Site
Mendoza, 5500, Argentina
Research Site
Pergamino, B2700CPM, Argentina
Research Site
Quilmes, B1878GEG, Argentina
Research Site
Rosario, S2000PBJ, Argentina
Research Site
Salta, A4400ANW, Argentina
Research Site
San Isidro, 1643, Argentina
Research Site
San Juan, 5400, Argentina
Research Site
San Miguel de Tucumán, 4000, Argentina
Research Site
San Miguel de Tucumán, T4000AXL, Argentina
Research Site
San Miguel de Tucumán, T4000ICL, Argentina
Research Site
Kardzhali, 6600, Bulgaria
Research Site
Pleven, 5800, Bulgaria
Research Site
Plovdiv, 4003, Bulgaria
Research Site
Sevlievo, 5400, Bulgaria
Research Site
Sofia, 1407, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Sofia, 1606, Bulgaria
Research Site
Sofia, 1784, Bulgaria
Research Site
Sofia, 1797, Bulgaria
Research Site
Osorno, 5290000, Chile
Research Site
Santiago, 7500010, Chile
Research Site
Santiago, 7500571, Chile
Research Site
Santiago, 7500588, Chile
Research Site
Santiago, 7500710, Chile
Research Site
Santiago, 7501126, Chile
Research Site
Santiago, 8320000, Chile
Research Site
Valdivia, 5090000, Chile
Research Site
Barranquilla, 080002, Colombia
Research Site
Barranquilla, 080020, Colombia
Research Site
Bogotá, 110221, Colombia
Research Site
Bucaramanga, 680003, Colombia
Research Site
Chía, 250001, Colombia
Research Site
Montería, 230002, Colombia
Research Site
Berlin, 10117, Germany
Research Site
Cologne, 50937, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Budapest, 1027, Hungary
Research Site
Budapest, 1097, Hungary
Research Site
Gyula, 5700, Hungary
Research Site
Székesfehérvár, 8000, Hungary
Research Site
Veszprém, 8200, Hungary
Research Site
Chiba, 260-8712, Japan
Research Site
Chūōku, 104-8560, Japan
Research Site
Hamamatsu, 431-3192, Japan
Research Site
Hiroshima, 734-8551, Japan
Research Site
Itabashi-ku, 173-8610, Japan
Research Site
Kita-gun, 761-0793, Japan
Research Site
Kitakyushu-shi, 807-8555, Japan
Research Site
Meguro-ku, 152-8902, Japan
Research Site
Meguro-ku, 153-8515, Japan
Research Site
Nagasaki, 852-8501, Japan
Research Site
Nagoya, 457-8510, Japan
Research Site
Nagoya, 460-0001, Japan
Research Site
Okayama, 700-8607, Japan
Research Site
Sagamihara-shi, 252-0375, Japan
Research Site
Sasebo-shi, 857-1195, Japan
Research Site
Sendai, 980-8574, Japan
Research Site
Shinjuku-ku, 160-8582, Japan
Research Site
Chihuahua City, 31000, Mexico
Research Site
Culiacán, 80000, Mexico
Research Site
Durango, 43080, Mexico
Research Site
Guadalajara, 44130, Mexico
Research Site
Guadalajara, 44650, Mexico
Research Site
Guadalajara, 44950, Mexico
Research Site
Mexicali, 21200, Mexico
Research Site
Mérida, 97000, Mexico
Research Site
Mérida, 97070, Mexico
Research Site
México, 03100, Mexico
Research Site
México, 03720, Mexico
Research Site
México, 06700, Mexico
Research Site
Quezon City, 1118, Philippines
Research Site
Katowice, 40-081, Poland
Research Site
Kościan, 64-000, Poland
Research Site
Krakow, 30-033, Poland
Research Site
Krakow, 30-363, Poland
Research Site
Krakow, 30-510, Poland
Research Site
Lodz, 90-368, Poland
Research Site
Lublin, 20-607, Poland
Research Site
Nowa Sól, 67-100, Poland
Research Site
Ustroń, 43-450, Poland
Research Site
Warsaw, 00-874, Poland
Research Site
Warsaw, 02-118, Poland
Research Site
Warsaw, 02-691, Poland
Research Site
Wroclaw, 50-088, Poland
Research Site
Wroclaw, 50-244, Poland
Research Site
Barcelona, 08036, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Madrid, 28702, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41010, Spain
Research Site
Valencia, 46026, Spain
Research Site
Muang, 50200, Thailand
Research Site
Rachathewi, 10400, Thailand
Research Site
Kyiv, 01601, Ukraine
Research Site
Kyiv, 02091, Ukraine
Research Site
Kyiv, 04050, Ukraine
Research Site
Odesa, 65025, Ukraine
Research Site
Vinnytsia, 21001, Ukraine
Research Site
Vinnytsia, 21029, Ukraine
Research Site
Zaporizhzhia, 69600, Ukraine
Research Site
Doncaster, DN2 5LT, United Kingdom
Research Site
Leeds, LS7 4SA, United Kingdom
Research Site
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Double Blind (Participant, Care Provider and Investigator) and OLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
June 8, 2021
Primary Completion
August 22, 2025
Study Completion (Estimated)
November 6, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
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. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- 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. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.