Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified June 2013 by AstraZeneca
Sponsor:
AstraZeneca
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01559090
First received: March 19, 2012
Last updated: June 5, 2013
Last verified: June 2013
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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
| Estimated Enrollment: | 21 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (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: 300 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| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559090
Contacts
| Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Locations
| Japan | |
| Research Site | Recruiting |
| Chiba, Japan | |
| Research Site | Not yet recruiting |
| Kitakushu, Japan | |
| Research Site | Recruiting |
| Sendai, Japan | |
| Research Site | Recruiting |
| Shimotsuke, Japan | |
| Research Site | Recruiting |
| Tokyo, 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: | June 5, 2013 |
| 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 Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013