A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

JRCT ID: jRCT2071210076

Registered date:15/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 03/03/2022
• Target sample size: 36
• Countries of recruitment: United States,Japan,Argentina,Japan,Bulgaria,Japan,Chile,Japan,Colombia,Japan,Hungary,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Russia,Japan,Ukraine,Japan,United Kingdom,Japan,Germany,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Approximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients
per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW).

Outcome(s)

Primary Outcome

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At week 52 ]

BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria:

- Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a 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 more or 2 new BILAG 2004 B or more.

- 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 the patient's lupus disease activity, where worsening is defined as an increase 0.30 points or more on a 3-point PGA VAS.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for 24 weeks prior or more to signing the ICF
2. To be eligible a patient must have SLEDAI-2K 6 points or more and "Clinical" SLEDAI-2K score 4 points or more at screening
3. BILAG2004 with at least 1 of the following:
- BILAG2004 level A disease in 1 organ system or more
- BILAG2004 level B disease in 2 organ systems or more
4. Physician's Global Assessment (PGA) score 1.0 or more on a 0 to 3 VAS at Screening
5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

Exclude criteria

7. Active severe or unstable neuropsychiatric SLE

8. Active severe SLE-driven renal disease

9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.

10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).

11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.

12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody

13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),

14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.

15. History of cancer, apart from:

a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy 3 months prior or more to Week 0 (Day 1)

b. Cervical cancer in situ treated with apparent success with curative therapy 1 year prior or more to Week 0 (Day 1).

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04877691