Anifrolumab Asian PhIII efficacy study for Systemic Lupus Erythematosus (SLE)

Study identifier:D3468C00003

ClinicalTrials.gov identifier:NCT04931563

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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

Medical condition

Active Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

Study drug

placebo

Sex

All

Estimated Enrollment

328

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 13 Sept 2021

Estimated Primary Completion Date: 28 Jan 2025

Estimated Study Completion Date: 28 Mar 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Aged 18 to 70 years.
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:
(a) oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for > 2 weeks;
(b) Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required;
(c) 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

1. 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.
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. Women participants with abnormal pap smear results.
12. Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor.
13. Known history of allergy to any component of the IP formulation or protein related products.
14. Receipt of any of the following:
(a) Intramuscular or IV glucocorticosteroids within 6 weeks;
(b) Any live or attenuated vaccine within 8 weeks;
(c) Any restricted medication listed in protocol;
(d) 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.

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Arms	Assigned Interventions
Placebo Comparator: 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.	Drug: placebo Intravenous infusion (IV)
Active Comparator: 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.	Biological/Vaccine: Anifrolumab Intravenous infusion (IV)

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]