Overview

This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments medi-546
Phase phase 2
Sponsor AstraZeneca
Collaborator MedImmune LLC
Start date April 2012
End date August 2014
Trial size 20 participants
Trial identifier NCT01559090, D3461C00002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MEDI-546 100 mg IV
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
(Experimental)
MEDI-546 300 mg IV
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
(Experimental)
MEDI-546 1000 mg IV
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.

Primary Outcomes

Measure
Description of the safety profile for MEDI-546 in terms of adverse events, vital signs (body temperature, blood pressure, pulse rate and respiratory rate) and clinical laboratory assessments and electrocardiograms.
time frame: From baseline up to Day 422 at Stage I, From baseline up to Day 1178 at Stage II

Secondary Outcomes

Measure
Description of the PK profile for MEDI-546 in terms of peak plasma concentration (Cmax), time to peak concentration (tmax), area under concentration curve (AUC) and terminal phase half-life (t1/2)
time frame: Stage I: predose/30 min post dose of Day1 and 337, predose of Day2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 338, 344, 351, 365, 393 and 422. Stage II: predose of Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178
Evaluation of the pharmacodynamics of MEDI-546 by assessing the impact on the type I interferon gene signature score.
time frame: Stage I: Day1, 29, 85, 141, 169, 253, 337, 365, 393 and 422. Stage II: Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178
Evaluation of Anti-drug antibody by assessing the number and percentage of patients developing detectable anti-MEDI-546 antibodies.
time frame: Stage I: Day1, 85, 141, 169, 253, 337, 365, 393 and 422. Stage II: Day1, 85, 169, 253, 337, 505, 673, 841, 1009, 1093, 1121 and 1178

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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)
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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.