A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)
Status: | Recruiting |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/21/2019 |
Start Date: | January 4, 2017 |
End Date: | July 25, 2022 |
Contact: | US Medical Information |
Email: | service@emdgroup.com |
Phone: | 888-275-7376 |
A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)
M2951 is an investigational drug under evaluation for treatment of autoimmune and
inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of
M2951 in Subjects with Systemic Lupus Erythematosus (SLE)
inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of
M2951 in Subjects with Systemic Lupus Erythematosus (SLE)
Inclusion Criteria:
- Eligible male and female subjects, aged 18 to 75 years
- Must have diagnosis of SLE with either the Systemic Lupus International Collaborating
Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of
Rheumatology (ACR) classification criteria for SLE, of at least six months duration
prior to Screening
- SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI
greater than or equal to (>=) 4) at Screening Visit
- And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or
anti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith
(anti-Sm) antibody at the time of Screening
- Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
- Subjects are not eligible for this study if they have active, clinically significant
interstitial lung disease or pulmonary arterial hypertension
- Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
- Acutely worsened renal function
- Central nervous system SLE
- Or within two weeks prior to Screening or during Screening: use of oral
corticosteroids greater than (>) 30 mg daily prednisone equivalent
- Use of injectable corticosteroids, or change in dose of corticosteroids.
- Other protocol defined exclusion criteria could apply.
We found this trial at
49
sites
Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Vasileios Kyttaris
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Southern California The University of Southern California is one of the world’s leading...
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Aurora, Colorado 80045
Principal Investigator: Susan Boackle
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Clearwater, Florida 33765
Principal Investigator: Robert Levin
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Detroit, Michigan 48202
Principal Investigator: Kathleen Maksimowicz-McKinnon
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Fort Lauderdale, Florida 33334
Principal Investigator: Yvonne Sherrer
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Glendale, Arizona 85304
Principal Investigator: Swati Bharadwaj
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7021 Augusta Road
Greenville, South Carolina 29604
Greenville, South Carolina 29604
Principal Investigator: Jeffrey Lawson
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La Palma, California 90623
Principal Investigator: Gerald Ho
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Mar del Plata, Buenos Aires B7600
Principal Investigator: Juan Pablo Gulin
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Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Phoenix, Arizona 85037
Principal Investigator: John Tesser
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Pittsburgh, Pennsylvania 15212
Principal Investigator: Susan Manzi
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4650 Palm Avenue
San Diego, California 92154
San Diego, California 92154
Principal Investigator: Steve Lee
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San Leandro, California 94578
Principal Investigator: Suneet Grewal
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Seattle, Washington
Principal Investigator: Sergey Moiseev
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Shreveport, Louisiana
Principal Investigator: Sarwat Umer
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Upland, California 91786
Principal Investigator: Antony Hou
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451 North Texas Avenue
Webster, Texas 77598
Webster, Texas 77598
Principal Investigator: Abdelnaser Elkhalili
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23101 Sherman Place
West Hills, California 91307
West Hills, California 91307
Principal Investigator: Nazanin Firooz
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