A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

NCT00657189 | Completed Phase 2

• 1 other identifier: MI-CP179
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 22

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.

Conditions

Lupus Erythematosus, Systemic; Lupus

Keywords

Sifalimumab; MEDI-545; Lupus erythematosus, systemic

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.

  Immediately following the first administration of study drug through Study Day 168.

Secondary Outcomes (1)

• A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545.

  At Study Day 98

Study Arms (5)

1

EXPERIMENTAL

MEDI-545

Drug: MEDI-545

2

EXPERIMENTAL

MEDI-545

Drug: MEDI-545

3

EXPERIMENTAL

MEDI-545

Drug: MEDI-545

4

EXPERIMENTAL

MEDI-545

Drug: MEDI-545

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MEDI-545 DRUG

100 mg once; SC Placebo × 12 doses on other weeks

1

Placebo DRUG

SC Placebo every week × 13 doses

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 18 years at the time of the first dose of study drug;
• Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
• Meet at least 4 of the 11 revised ACR classification criteria for SLE
• Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
• Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
• Treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or dapsone;
• Women, unless surgically sterile or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from screening through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) from Study Day 0 through the end of the study;
• Ability to complete the study period, including the follow-up period through Study Day 168; and
• Willing to forego other forms of experimental treatment during the study.

You may not qualify if:

• Have received MEDI-545 within 120 days prior to screening;
• History of allergy or reaction to any component of the study drug formulation;
• Have received the following medications within 28 days before randomization:
• Systemic cyclophosphamide at any dose
• Cyclosporine at any dose
• Thalidomide at any dose
• Hydroxychloroquine \> 600 mg/day
• Mycophenolate mofetil \> 3 g/day
• Methotrexate \> 25 mg/week
• Azathioprine \> 3 mg/kg/day
• Have received fluctuating doses of the following within 28 days before randomization:
• Antimalarials
• Mycophenolate mofetil
• Methotrexate
• Leflunomide

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (22)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Huntington Beach, California, 92646, United States

Location

Research Site

Upland, California, 91786, United States

Location

Research Site

Colorado Springs, Colorado, 80910, United States

Location

Research Site

Farmington, Connecticut, 06030-5353, United States

Location

Research Site

Clearwater, Florida, 33765-2616, United States

Location

Research Site

Ocala, Florida, 34474, United States

Location

Research Site

Atlanta, Georgia, 30303, United States

Location

Research Site

Decatur, Georgia, 30033, United States

Location

Research Site

Marrietta, Georgia, 30060, United States

Location

Research Site

West Fayetteville, Georgia, 30269, United States

Location

Research Site

Baltimore, Maryland, 21205, United States

Location

Research Site

Lansing, Michigan, 48910, United States

Location

Research Site

Brooklyn, New York, 10003, United States

Location

Research Site

Charlotte, North Carolina, 28210, United States

Location

Research Site

Cincinnati, Ohio, 45219, United States

Location

Research Site

Oklahoma City, Oklahoma, 73104, United States

Location

Research Site

Charleston, South Carolina, 29406, United States

Location

Research Site

Columbia, South Carolina, 29204, United States

Location

Research Site

Houston, Texas, 77004, United States

Location

Research Site

Sugarland, Texas, 77479, United States

Location

Research Site

Seattle, Washington, 98111, United States

Location

Related Publications (1)

• Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B; Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011 Nov;70(11):1905-13. doi: 10.1136/ard.2010.144485. Epub 2011 Jul 27.

  PMID: 21798883 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

sifalimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Warren Greth, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (22)