Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559090
• Other study ID #: D3461C00002
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2012
• Est. completion date: February 21, 2017

Study information

• Verified date: March 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 21, 2017
• Est. primary completion date: August 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• MEDI-546
Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
• MEDI-546
Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
• MEDI-546
Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Locations

Country	Name	City	State
Japan	Research Site	Chiba-shi
Japan	Research Site	Chuo-ku
Japan	Research Site	Ota-ku
Japan	Research Site	Sendai-shi
Japan	Research Site	Shimotsuke-shi
Japan	Research Site	Shinjuku-ku

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Summary of Adverse Events		Stage I (up to 48 weeks)
Secondary	Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax		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
Secondary	Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast		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
Secondary	Anti-drug Antibody (ADA)	MEDI-546 antibody detection measured by electrochemiluminescence (ECL).	Stage I (up to Week 48)