Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus

Phase 1

• Conditions: Moderate-to-severe Systemic Lupus Erythematosus (SLE); MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-004529-22-BG
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-23
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1.Patients who have a diagnosis of paediatric or adult SLE according to the ACR 1997 revised criteria for = 24 weeks prior to signing the ICF
2.To be eligible a patient must have SLEDAI-2K = 6 points and Clinical” SLEDAI-2K score =4 points coming from clinical components (Clinical SLEDAI-2K) at screening. In addition, the following criteria must be met:
Clinical SLEDAI of at least = 4 points at Day 1 (randomization).
Note: The Clinical SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures: Includes points from the following clinical components: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis. Excludes points attributed to a fever, an SLE headache, and organic brain syndrome. Clinical SLEDAI-2K points at screening cannot only be due to alopecia and mucosal ulcers.
3.At Screening, BILAG2004 with at least 1 of the following as confirmed by Disease Activity Central Team Review:
a.BILAG2004 level A disease in = 1 organ system
b.BILAG2004 level B disease in = 2 organ systems
4.Physician’s Global Assessment (PGA) score = 1.0 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 therapy with antimalarials and/or immunosuppressants and glucocorticoids alone or in combination
7.Contraception Requirements
Male patients:
All fertile males who are sexually active must use condom from Day 1 until at least 16 weeks after receipt of the final dose of study intervention. It is strongly recommended that the female partner of a male patient also use an effective method of contraception from Table 9 throughout this period.
Male patients must not donate sperm during the course of the study and for 16 weeks after the last dose of the study intervention.
Female patients:
Negative serum ß-human chorionic gonadotropin (ß-hCG) test at screening (females of childbearing potential only).
Women of childbearing potential must have a negative urine pregnancy test at randomisation (Day 1), prior to administration of study intervention.
Woman of non-childbearing potential must be postmenopausal or have been surgically sterilised (for example: bilateral oophorectomy, or complete hysterectomy), which should be documented in the patient's medical records.
Age-specific requirements may apply for a postmenopausal state. Females of childbearing potential must use 1 highly effective method of contraception plus a male condom, from Screening until 16 weeks after the final dose of study intervention, unless the patient is surgically sterile (eg, bilateral oophorectomy, tubal ligation or complete hysterectomy), has a sterile male/non-fertile male partner, is at least 12 months postmenopausal, or practices sustained abstinence consistent with the patient’s customary lifestyle.
Malignancy:
Females who have been or are sexually active with an intact cervix must have ocumentation of a cervical cancer screening (Pap smear or human papilloma virus [HPV] tests as per local guidelines) with a normal test result within 2 years prior to randomisation. Any abnormal cervical cancer screening result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility.
Females aged < 25 years, who have never been sexually active or have well-documented HPV vaccination records may not require a cervical c

Exclusion Criteria

1.Active severe or unstable neuropsychiatric SLE
2.Active severe SLE-driven renal disease
3.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.
4.Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
5.Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
6.History of cancer, apart from:
a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy = 3 months prior to Week 0 (Day 1)
b. Cervical cancer in situ treated with apparent success with curative therapy = 1 year prior to Week 0 (Day 1)
7.Any history of severe COVID-19 infection eg. prolonged hospitalisation [hospitalisation for observational purposes is not exclusionary] or any prior COVID-19 infection with documented long COVID and/or clinically significant unresolved sequelae
Any mild/asymptomatic COVID-19 infection (lab confirmed or suspected based on clinical symptoms) within the last 6 weeks prior to first dosing
8.Lactating, breastfeeding or pregnant females or females who intend to become pregnant or begin
breastfeeding anytime from initiation of Screening until the end of the 16-week safety follow-up period following last dose of study intervention.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified