Clinical trial NCT01559090: Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Official title: A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Japan
Phase2
Safety
Tolerability
Systemic Lupus Erythematosus
SLE, MEDI-546
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: MedImmune LLC
First posted: 2012-03-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

Detailed description: A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and 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)

Eligibility 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 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:

* 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.

Primary outcomes:
measure: Overall Summary of Adverse Events
timeFrame: Stage I (up to 48 weeks)
Secondary outcomes:
measure: Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax
timeFrame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
measure: Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast
timeFrame: Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29
measure: Anti-drug Antibody (ADA)
timeFrame: Stage I (up to Week 48)
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shimotsuke-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: Roberta Weiss, MD
role: STUDY_DIRECTOR
References: