A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438489
• Other study ID #: CD-IA-MEDI-546-1013
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2011
• Last updated: July 10, 2015
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening

• Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks

• Weight greater than or equal to 40 kg

• Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives

• Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment

• No evidence of cervical malignancy on Pap smear within 2 years of randomization

• Female subjects must be willing to avoid pregnancy

• Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization

Exclusion Criteria:

• Active severe SLE-driven renal disease or unstable renal disease prior to screening

• Active severe or unstable neuropsychiatric SLE

• Clinically significant active infection including ongoing and chronic infections

• History of human immunodeficiency virus (HIV)

• Confirmed Positive tests for hepatitis B or positive test for hepatitis C

• History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes

• Live or attenuated vaccine within 4 weeks prior to screening

• Subjects with significant hematologic abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• MEDI-546
Low dose of MEDI-546 administered as an intravenous infusion at the predetermined intervals
• MEDI-546
High dose of MEDI-546 administered as an intravenous infusion at predetermined intervals

Other:
• Placebo
Matching placebo to MEDI-546 administered as an intravenous infusion at predetermined intervals

Locations

Country	Name	City	State
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Chia
Colombia	Research Site	Medellin
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Uherske Hradiste
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
India	Research Site	Dantoli-Nagpur
India	Research Site	Hyderabad
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Pune
India	Research Site	Secunderabad
Korea, Republic of	Research Site	Gwangjin-gu
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Seodaemun-gu
Korea, Republic of	Research Site	Suwon-si
Mexico	Research Site	Guadalajara
Mexico	Research Site	Leon
Mexico	Research Site	Mexico
Mexico	Research Site	Toluca
Peru	Research Site	Arequipa
Peru	Research Site	Lima
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Krakow
Poland	Research Site	Nadarzyn
Poland	Research Site	Poznan
Romania	Research Site	Brasov
Romania	Research Site	Iasi
Romania	Research Site	Targu Mures
Taiwan	Research Site	Chiayi
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Zhongzheng District
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Lviv
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Vinnitsya
Ukraine	Research Site	Vinnytsia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Birmingham	Alabama
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Houston	Texas
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Indianapolis	Indiana
United States	Research Site	La Jolla	California
United States	Research Site	La Palma	California
United States	Research Site	Las Cruces	New Mexico
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	Ocala	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Desert	California
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Leandro	California
United States	Research Site	Seattle	Washington
United States	Research Site	Spokane	Washington
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Tampa	Florida
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Colombia,  Czech Republic,  Hungary,  India,  Korea, Republic of,  Mexico,  Peru,  Poland,  Romania,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of response in a systemic lupus erythematosus (SLE) responder index	Number and percentage of participants achieving a response in an SLE responder index at Day 169 (or 6 months)	Day 169 (or 6 months)	No
Secondary	Achievement of response in a systemic lupus erythematosus (SLE) responder index	Number and percentage of participants achieving a response in an SLE responder index at Day 365 (or 1 year)	Day 365 (or 1 year)	No