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

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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)


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
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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330 Brookline Ave
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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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Anaheim, California 92805
Principal Investigator: Rafaelito Victoria
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Anniston, Alabama 36207
Principal Investigator: Vishala Chindalore
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Aurora, Colorado 80045
Principal Investigator: Susan Boackle
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Bay City, Michigan 48706
Principal Investigator: Jeffrey Potts
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Bronx, New York 10467
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Chicago, Illinois 60637
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Clearwater, Florida 33765
Principal Investigator: Robert Levin
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Covina, California 91723
Principal Investigator: Samy Metyas
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Dallas, Texas 75231
Principal Investigator: Roy Fleischmann
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Debary, Florida
Principal Investigator: Sanjiv Kapil
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Detroit, Michigan 48202
Principal Investigator: Kathleen Maksimowicz-McKinnon
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Flint, Michigan
Principal Investigator: Ali Karrar
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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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Glendale, California 91204
Principal Investigator: Dan La
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Greensboro, North Carolina 27408
Principal Investigator: Tauseef Syed
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7021 Augusta Road
Greenville, South Carolina 29604
Principal Investigator: Jeffrey Lawson
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Houston, Texas 77004
Principal Investigator: Jacqueline Vo
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Houston, Texas
Principal Investigator: Philip Waller
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La Palma, California 90623
Principal Investigator: Gerald Ho
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Lakewood, California 90712
Principal Investigator: Wagdy Kades
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Los Angeles, California 90048
Principal Investigator: Daniel Wallace
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Mar del Plata, Buenos Aires B7600
Principal Investigator: Juan Pablo Gulin
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Marietta, Georgia 30060
Principal Investigator: Roel Querubin
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Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
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Miami, Florida
Principal Investigator: Juan Prieto
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New Haven, Connecticut 06520
Principal Investigator: Fotios Koumpouras
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535 E 70th St
New York, New York 10021
(212) 606-1000
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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Plantation, Florida
Principal Investigator: Guillermo Valenzuela
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Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
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Saint Louis, Missouri 63110
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4650 Palm Avenue
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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Syracuse, New York 13210
Principal Investigator: Andras Perl
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Tampa, Florida 33613
Principal Investigator: Harris McIlwain
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Tampa, Florida
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The Woodlands, Texas
Principal Investigator: Amber Khan
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Tomball, Texas 77375
Principal Investigator: Shaikh Ali
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Upland, California 91786
Principal Investigator: Antony Hou
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451 North Texas Avenue
Webster, Texas 77598
Principal Investigator: Abdelnaser Elkhalili
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23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz
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