Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus - Tulip SC

Study identifier:D3465C00001

ClinicalTrials.gov identifier:NCT04877691

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Study evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

Study drug

Medi-546, Placebo

Sex

All

Estimated Enrollment

360

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 08 Jun 2021

Estimated Primary Completion Date: 28 Aug 2024

Estimated Study Completion Date: 23 Dec 2024

Study design

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

Verification:

Verified 01 Feb 2023 by AstraZeneca

Collaborators

IQVIA

Inclusion and exclusion criteria

Inclusion Criteria

Inclusion CriteriaErythematosus
1. Patients who have a diagnosis of pediatric 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 at screening
3. BILAG2004 with at least 1 of the following:
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 DMARD, glucocorticoids or anti-malarials alone or in combinations.

Exclusion 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 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).

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Arms	Assigned Interventions
Experimental: Anifrolumab Solution for injection in aPFS	Drug: Medi-546 Patients will have IP administered or will self-administer IP under supervision by site staff at Weeks 0, 1, and 2. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration, as follows: • - W0 and W1 – 1 kit to be administered at clinic • - W2 – 3 kits (1 to be administered at clinic, 2 to be taken home) • - W4 – W48 (every 4 weeks) – 5 kits (1 to be administered at clinic, 4 to be taken home) Patients will have approximately 65 kits (including back-up kits) dispensed to them over the course of the 52-week treatment period Other Name: MEDI-546
Placebo Comparator: Placebo Solution for injection in aPFS	Drug: Placebo Solution for injection in aPFS

Arms

Assigned Interventions

Experimental: Anifrolumab
Solution for injection in aPFS

Drug: Medi-546
Patients will have IP administered or will self-administer IP under supervision by site staff at Weeks 0, 1, and 2. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration, as follows: • - W0 and W1 – 1 kit to be administered at clinic • - W2 – 3 kits (1 to be administered at clinic, 2 to be taken home) • - W4 – W48 (every 4 weeks) – 5 kits (1 to be administered at clinic, 4 to be taken home) Patients will have approximately 65 kits (including back-up kits) dispensed to them over the course of the 52-week treatment period

Other Name: MEDI-546

Placebo Comparator: Placebo
Solution for injection in aPFS

Drug: Placebo
Solution for injection in aPFS

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]