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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01559090
First received: March 19, 2012
Last updated: October 14, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: MEDI-546
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 814 at Stage II ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: at predose/30 min post dose of Day 1 and Day 337, at predose of Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 338, 344, 351, 365, 393 and 422. Stage II: at predose of Day 1, 85, 169, 253, 337, 505, 673, 729, 757 and 814 ] [ Designated as safety issue: No ]
    Stage I: at predose and at 30 min post dose of Day 1 and Day 337, at predose of Days 2, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 338, 344, 351, 365, 393 and 422. Stage II: at predose of Day 1, 85, 169, 253, 337, 505, 673, 729, 757 and 814


Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-546 100 mg IV
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 104 wks
Experimental: 2
MEDI-546 300 mg IV
Drug: 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 104 wks
Experimental: 3
MEDI-546 1000 mg IV
Drug: 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 104 wks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559090

Locations
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, Japan
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Study Director: Stephen Yoo, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01559090     History of Changes
Other Study ID Numbers: D3461C00002
Study First Received: March 19, 2012
Last Updated: October 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Japan
Phase2
Safety
Tolerability
Systemic Lupus Erythematosus
SLE, MEDI-546

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014