A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety

To describe the attainment of DORIS remission in IS-naïve and biologic-naïve participants with Systemic Lupus Erythematous (SLE) on antimalarials with or without (glucocorticoid) GC, initiated on anifrolumab

Secondary objectives 13

1. 1. To assess the attainment of low-level disease activity (as measured by Lupus Low Disease Activity State [LLDAS] and LLDAS-5) in participants initiated on anifrolumab
2. 2.To assess the time spent in DORIS remission, LLDAS or LLDAS-5 for participants initiated on anifrolumab
3. 3. To assess the proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS-5 through to Week 52
4. 4. To assess the proportion of participants initiated on anifrolumab, sustaining DORIS remission, LLDAS or LLDAS for three or more consecutive visits
5. 5. To assess the time to attain and sustain DORIS, or LLDAS, or LLDAS-5
6. 6. To assess the daily GC dose at Week 40 and 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering and to assess the maintenance of this GC reduction through Week 52
7. 7. To assess the reduction in GC use from Week 4 to Week 40 in participants initiated on anifrolumab alongside a systematic approach to GC tapering and to assess the maintenance of this percent reduction in GC dose through Week 52
8. 8. To assess the cumulative GC dose from Week 0 to Week 52 in participants initiated on anifrolumab alongside a systematic approach to GC tapering
9. 9. To assess the attainment of DORIS-0 in participants initiated on anifrolumab
10. 10. To assess the time to first moderate- to-severe flare in participants initiated on anifrolumab
11. 11. To assess the change in active skin manifestations of SLE in participants initiated on anifrolumab
12. 12. To assess the change in joint activity in participants initiated on anifrolumab
13. 13. To assess the change in QoL and fatigue in participants initiated on anifrolumab

Conditions and MedDRA coding

Systemic lupus erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Males or females aged 18 to 70 years of age inclusive at the time of sigining the ICF
2. 2. Participants who have a diagnosis of SLE, confirmed by a rheumatologist, for at least 3 months (≥ 12 weeks) prior to signing the ICF (SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria)
3. 3. ANA-positive as determined by a documented historical test result confirmed at Screening for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80) or at least one of the following determined at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
4. 4. Must be receiving the standard therapy regimen: antimalarials with or without OCSs
5. 5. Must have at screening and baseline: (a) Clinical SLEDAI-2K ≥ 4 points OR (b) Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)
6. Additional details on inclusion criteria are described in protocol section 5.1 Inclusion Criteria

Exclusion criteria 16

1. 1. History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome .
2. 2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed if this is not the sole or the predominant feature of their SLE. Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit are excluded.
3. 3.Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded.
4. 4. History or evidence of suicidal ideation (severity of 4 or 5) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant
5. 5. Active severe or unstable neuropsychiatric SLE
6. 6. Active severe SLE-driven renal disease where protocol-specified standard therapy is insufficient
7. 7. History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS) within one year prior to signing the ICF.
8. 8. History of recurrent infection requiring hospitalization and IV antibiotics
9. 9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
10. 10. Confirmed positive test for hepatitis B serology
11. 11. Active hepatitis C infection
12. 12. Clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF
13. 13. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1)
14. 14. Clinically significant chronic infection within 8 weeks prior to signing the ICF
15. 15. Severe Herpes Zostet (HZ) or recurrent HZ
16. 16. Malignancy. History of cancer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants who are in DORIS remission at Week 52

Secondary endpoints 5

1. 1. Proportion of participants who are in LLDAS, or LLDAS- 5 at Week 28 and 52
2. 2. Proportion of time spent in DORIS remission, in LLDS and LLDAS-5
3. 3. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for all subsequent visits up to and including Week 52
4. 4. Proportion of participants who achieve DORIS, LLDS and LLDAS-5 that is sustained for three or more consecutive visits
5. 5. Time to first DORIS, LLDS and LLDAS-5 that is sustained through to Week 52

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca AB

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca AB

Third parties 1

Locations

3 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications