Active Systemic Lupus ErythematosusPhase 3NCT04931563
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
A Phase 3 study testing Anifrolumab in people with Active Systemic Lupus Erythematosus, run by AstraZeneca at 65 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 65 sitesin 6 countries
- Study dates
- 13 Sep 2021to 10 Jun 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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;
- Any live or attenuated vaccine within 8 weeks;
- Any restricted medication listed in protocol;
- Blood transfusion within 4 weeks. 15 Regular use of > 1 NSAID within 2 weeks or receipt of fluctuating doses of a NSAID within 2 weeks.
- 16. Certain laboratory test results requirements. 17. Concurrent enrolment in another clinical study. 18. History or current alcohol, drug or chemical abuse within 1 year. 19. Major surgery within 8 weeks or planned elective major surgery.
Trial locations and contacts
65 sites in 6 countries.
65 sites in 6 countries
China45 sites
Research Site
Baoding, 071000
Research Site
Baotou, 014010
Research Site
Beijing, 100029
Research Site
Beijing, 100034
Research Site
Beijing, 100144
Research Site
Beijing, 100191
Research Site
Beijing, 100730
Research Site
Bengbu, 233004
Research Site
Binzhou, 256603
Research Site
Changchun
Research Site
Changsha, 410008
Research Site
Chuangchun, 130012
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510260
Research Site
Guilin, 541001
Research Site
Hangzhou, 310006
Research Site
Hengyang, 421001
Research Site
Jieyang, 522000
Research Site
Jinan, 250012
Research Site
Jining, 272011
Research Site
Kunming, 650032
Research Site
Lanzhou, 730000
Research Site
Linyi, 276003
Research Site
Luoyang, 471003
Research Site
Nanchang, 330006
Research Site
Nanchong, 637000
Research Site
Nanjing, 210008
Research Site
Nanyang, 473005
Research Site
Shanghai, 200025
Research Site
Shengyang, 110004
Research Site
Shenyang, 110001
Research Site
Shenzhen, 518020
Research Site
Shijiazhuang, 050001
Research Site
Suzhou, 215006
Research Site
Tianjin, 300050
Research Site
Ürümqi, 831118
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Wuxi, 214002
Research Site
Xiamen, 361003
Research Site
Xinxiang, 453002
Research Site
Yinchuan, 750004
Research Site
Zaozhuang, 277102
Research Site
Zhengzhou, 450052
Taiwan8 sites
Research Site
Kaohsiung City, 81362
Research Site
New Taipei City, 220
Research Site
New Taipei City, 23561
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Taipei, 11220
Research Site
Taipei, 114
Research Site
Taoyuan, 333
Philippines5 sites
Research Site
Davao City, PH-8000
Research Site
Iloilo City, 5000
Research Site
Lipa City, 4217
Research Site
Manila, 1000
Research Site
Quezon City, 1112
South Korea4 sites
Research Site
Gwangju, 501-757
Research Site
Seoul, 04763
Research Site
Seoul, 6591
Research Site
Suwon, 16499
About this study
Official title: 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
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).
Read the detailed description
This is a Phase III, multicenter, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of 300 mg anifrolumab versus placebo in participants with moderate to severe, autoantibody positive SLE while receiving SOC treatment. The study will be performed in participants aged 18 to 70 years of age.
Participants with a confirmed diagnosis of moderate to severe active SLE and are currently receiving SOC comprising of oral corticosteroids (OCSs) and/or antimalarial, and/or immunosuppressants, either alone or any combination of them, for a required duration of treatment at a stable dose, as described in the inclusion criteria shall be included. Participants must have eligible scores for SLEDAI-2K, BILAG-2004, and PGA as confirmed by the DACRT.
Eligible participants will be randomised in a 1:1 ratio to receive either a fixed intravenous dose of 300 mg anifrolumab plus SOC or placebo plus SOC every 4 weeks (Q4W) for a total of 13 doses (Week 0 to Week 48), with the primary endpoint evaluated at the Week 52 visit.
- Conditions
- Active Systemic Lupus Erythematosus
- Being tested
- Anifrolumab, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabBiological
Intravenous infusion (IV)
placeboDrug
Intravenous infusion (IV)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo 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. Receives: Drug: placebo |
| anifrolumab | Active comparator | Anifrolumab 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. Receives: Biological: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 52
Secondary outcomes (3)
The Proportion of Participants Who Achieve SRI(4) Response at Week 52
SRI(4) response defined by meeting all of the following criteria:
- Reduction from baseline of ≥ 4 points in the SLEDAI-2K;
- No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items compared to baseline;
- No worsening from baseline in the participants' lupus disease activity defined by an increase ≥0.30 points on a 3-point PGA VAS;
Measured: 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
Maintained OCS reduction defined by meeting all of the following criteria:
- Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40
- Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52
Measured: Week 52
Annualized Flare Rate Through Week 52
Annualised flare rate with flare defined as either 1 or more new BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the previous visit
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start13 Sep 2021
- Primary completion7 Apr 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931563
- Sponsor's protocol ID
- D3468C00003
- Status last verified
- May 2026
- First submitted
- 29 Apr 2021
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.