Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Anifrolumab in Asian Participants With Active Systemic Lupus Erythematosus
1 other identifier
interventional
277
6 countries
65
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).
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 Sep 2021
Typical duration for phase_3
65 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
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedOctober 16, 2025
October 1, 2025
3.6 years
April 29, 2021
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in proportion of participants who are responders between anifrolumab and placebo
Composite endpoint (BICLA),a composite binary endpoint defined by meeting all of the following criteria: * 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 participants' lupus disease activity, where worsening is defined as an increase of ≥0.30 points on a 3-point PGA visual analogue scale (VAS)
Week 52
Secondary Outcomes (3)
The proportion of participants who achieve SRI(4) response at week 52
Week 52
The proportion of participants who achieve an oral corticosteroid (OCS) dose ≤7.5 mg/day at Week 40, which is maintained through Week 52 in the subgroup of those with baseline OCS ≥10 mg/day
Week 52
Annualized flare rate
Week 52
Study Arms (2)
placebo
PLACEBO COMPARATORPlacebo will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
anifrolumab
ACTIVE COMPARATORAnifrolumab will be administered via controlled IV infusion pump into a peripheral vein over a minimum of 30 minutes Q4W from Week 0 to Week 48. Each dose must be at least 14 days apart.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 to 70 years.
- Body weight ≥ 40 kg.
- Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
- Must be receiving at least one of the following SOC regimens at screening:
- oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for \> 2 weeks;
- Immunosuppressant(s) with or without OCS and must be stable for ≥ 8 weeks;
- Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
- At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
- SLEDAI-2K score ≥ 6 points at screening and "Clinical" SLEDAI-2K score ≥4 points at both screening and Day1(randomisation), and BILAG with at least 1 level A organ system or 2 level B organ system, and PGA score ≥ 1.0 at screening.
- Chest imaging shows no clinically significant abnormalities (unless due to SLE).
- No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
- All participants should use effective contraception methods as protocol requests.
- Any negative SARS-CoV-2 RT-PCR test result at screening and no known or suspected COVID-19 infection or exposure within 2 weeks prior to screening and between screening and randomisation visits.
You may not qualify if:
- History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
- History or evidence of suicidal ideation or suicidal behavior.
- History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
- History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
- History of immunodeficient condition, HIV positive included.
- Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive.
- History of severe case of herpes zoster.
- Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
- Acute COVID-19 infection or history of severe COVID-19.
- History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
- Female participants with abnormal pap smear results.
- Prior receipt of anifrolumab ,or any commercially available Janus kinase (JAK) inhibitor ≤ 12 weeks or Bruton's tyrosine kinase (BTK) inhibitor ≤ 24weeks prior to signing the ICF; any investigational medicinal product(small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.
- Known history of allergy to any component of the IP formulation or protein related products.
- Receipt of any of the following:
- Intramuscular or IV glucocorticosteroids within 6 weeks;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (65)
Research Site
Baoding, 071000, China
Research Site
Baotou, 014010, China
Research Site
Beijing, 100029, China
Research Site
Beijing, 100034, China
Research Site
Beijing, 100144, China
Research Site
Beijing, 100191, China
Research Site
Beijing, 100730, China
Research Site
Bengbu, 233004, China
Research Site
Binzhou, 256603, China
Research Site
Changchun, China
Research Site
Changsha, 410008, China
Research Site
Chuangchun, 130012, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510260, China
Research Site
Guilin, 541001, China
Research Site
Hangzhou, 310006, China
Research Site
Hengyang, 421001, China
Research Site
Jieyang, 522000, China
Research Site
Jinan, 250012, China
Research Site
Jining, 272011, China
Research Site
Kunming, 650032, China
Research Site
Lanzhou, 730000, China
Research Site
Linyi, 276003, China
Research Site
Luoyang, 471003, China
Research Site
Nanchang, 330006, China
Research Site
Nanchong, 637000, China
Research Site
Nanjing, 210008, China
Research Site
Nanyang, 473005, China
Research Site
Shanghai, 200025, China
Research Site
Shengyang, 110004, China
Research Site
Shenyang, 110001, China
Research Site
Shenzhen, 518020, China
Research Site
Shijiazhuang, 050001, China
Research Site
Suzhou, 215006, China
Research Site
Tianjin, 300050, China
Research Site
Ürümqi, 831118, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430022, China
Research Site
Wuhan, 430030, China
Research Site
Wuxi, 214002, China
Research Site
Xiamen, 361003, China
Research Site
Xinxiang, 453002, China
Research Site
Yinchuan, 750004, China
Research Site
Zaozhuang, 277102, China
Research Site
Zhengzhou, 450052, China
Research Site
Hong Kong, 00000, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Davao City, PH-8000, Philippines
Research Site
Iloilo City, 5000, Philippines
Research Site
Lipa City, 4217, Philippines
Research Site
Manila, 1000, Philippines
Research Site
Quezon City, 1112, Philippines
Research Site
Gwangju, 501-757, South Korea
Research Site
Seoul, 04763, South Korea
Research Site
Seoul, 6591, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Kaohsiung City, 81362, Taiwan
Research Site
New Taipei City, 220, Taiwan
Research Site
New Taipei City, 23561, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Taipei, 11220, Taiwan
Research Site
Taipei, 114, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Bangkok, 10400, Thailand
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
June 18, 2021
Study Start
September 13, 2021
Primary Completion
April 7, 2025
Study Completion
June 10, 2025
Last Updated
October 16, 2025
Record last verified: 2025-10
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. 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 deidentified 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.