Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)
NCT ID: NCT04931563
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2021-09-13
2025-06-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
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.
placebo
Intravenous infusion (IV)
anifrolumab
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.
Anifrolumab
Intravenous infusion (IV)
Interventions
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Anifrolumab
Intravenous infusion (IV)
placebo
Intravenous infusion (IV)
Eligibility Criteria
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Inclusion Criteria
2. Body weight ≥ 40 kg.
3. Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
4. Must be receiving at least one of the following SOC regimens at screening:
1. oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for \> 2 weeks;
2. Immunosuppressant(s) with or without OCS and must be stable for ≥ 8 weeks;
3. Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
5. At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
6. 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.
7. Chest imaging shows no clinically significant abnormalities (unless due to SLE).
8. No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
9. All participants should use effective contraception methods as protocol requests.
10. 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.
Exclusion Criteria
2. History or evidence of suicidal ideation or suicidal behavior.
3. History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
4. 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.
5. History of immunodeficient condition, HIV positive included.
6. Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive.
7. History of severe case of herpes zoster.
8. Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
9. Acute COVID-19 infection or history of severe COVID-19.
10. History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
11. Female participants with abnormal pap smear results.
12. 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.
13. Known history of allergy to any component of the IP formulation or protein related products.
14. Receipt of any of the following:
1. Intramuscular or IV glucocorticosteroids within 6 weeks;
2. Any live or attenuated vaccine within 8 weeks;
3. Any restricted medication listed in protocol;
4. 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.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Baoding, , China
Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Binzhou, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Chuangchun, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guilin, , China
Research Site
Hangzhou, , China
Research Site
Hengyang, , China
Research Site
Jieyang, , China
Research Site
Jinan, , China
Research Site
Jining, , China
Research Site
Kunming, , China
Research Site
Lanzhou, , China
Research Site
Linyi, , China
Research Site
Luoyang, , China
Research Site
Nanchang, , China
Research Site
Nanchong, , China
Research Site
Nanjing, , China
Research Site
Nanyang, , China
Research Site
Shanghai, , China
Research Site
Shengyang, , China
Research Site
Shenyang, , China
Research Site
Shenzhen, , China
Research Site
Shijiazhuang, , China
Research Site
Suzhou, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Wuxi, , China
Research Site
Xiamen, , China
Research Site
Xinxiang, , China
Research Site
Yinchuan, , China
Research Site
Zaozhuang, , China
Research Site
Zhengzhou, , China
Research Site
Hong Kong, , Hong Kong
Research Site
Hong Kong, , Hong Kong
Research Site
Davao City, , Philippines
Research Site
Iloilo City, , Philippines
Research Site
Lipa City, , Philippines
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Gwangju, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Countries
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Other Identifiers
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D3468C00003
Identifier Type: -
Identifier Source: org_study_id
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