FindTrial
Sign In

A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safetyand Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE)

A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safetyand Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221785
Enrollment
Unknown
Registered
2012-05-11
Start date
2012-05-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

investigational material(s) Generic name etc : MEDI-546 INN of investigational material : Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational m

Sponsors

AstraZeneca
Lead Sponsor
MedImmune LLC
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE. - Weight greater than or equal to 40.0 kg. - Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for 24 weeks or more prior to screening. - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives. - Active moderate to severe SLE disease based on SLE disease activity score.

Exclusion criteria

Exclusion criteria: - Active severe or unstable neuropsychiatric SLE. - Active severe SLE-driven renal disease or unstable renal disease. - Clinically significant active infection including ongoing and chronic infections. - Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection. - Confirmed positive tests for hepatitis B or positive test for hepatitis C.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026