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

Use our guide to learn which trials are right for you!

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
7021 Augusta Road
Greenville, South Carolina 29604
Principal Investigator: Jeffrey Lawson
361
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
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...
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
344
mi
from 43215
Chapel Hill, NC
Click here to add this to my saved trials
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...
660
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
1970
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Anaheim, California 92805
Principal Investigator: Rafaelito Victoria
1960
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
Anniston, Alabama 36207
Principal Investigator: Vishala Chindalore
461
mi
from 43215
Anniston, AL
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Susan Boackle
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
Bay City, Michigan 48706
Principal Investigator: Jeffrey Potts
255
mi
from 43215
Bay City, MI
Click here to add this to my saved trials
Bronx, New York 10467
485
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
Chicago, Illinois 60637
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33765
Principal Investigator: Robert Levin
829
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
Covina, California 91723
Principal Investigator: Samy Metyas
1952
mi
from 43215
Covina, CA
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: Roy Fleischmann
905
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Debary, Florida
Principal Investigator: Sanjiv Kapil
772
mi
from 43215
Debary, FL
Click here to add this to my saved trials
Detroit, Michigan 48202
Principal Investigator: Kathleen Maksimowicz-McKinnon
165
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
Flint, Michigan
Principal Investigator: Ali Karrar
213
mi
from 43215
Flint, MI
Click here to add this to my saved trials
Fort Lauderdale, Florida 33334
Principal Investigator: Yvonne Sherrer
970
mi
from 43215
Fort Lauderdale, FL
Click here to add this to my saved trials
Glendale, Arizona 85304
Principal Investigator: Swati Bharadwaj
1665
mi
from 43215
Glendale, AZ
Click here to add this to my saved trials
Glendale, California 91204
Principal Investigator: Dan La
1970
mi
from 43215
Glendale, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Principal Investigator: Tauseef Syed
321
mi
from 43215
Greensboro, NC
Click here to add this to my saved trials
Houston, Texas 77004
Principal Investigator: Jacqueline Vo
993
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Houston, Texas
Principal Investigator: Philip Waller
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
La Palma, California 90623
Principal Investigator: Gerald Ho
1967
mi
from 43215
La Palma, CA
Click here to add this to my saved trials
Lakewood, California 90712
Principal Investigator: Wagdy Kades
1971
mi
from 43215
Lakewood, CA
Click here to add this to my saved trials
Los Angeles, California 90048
Principal Investigator: Daniel Wallace
1978
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
Mar del Plata, Buenos Aires B7600
Principal Investigator: Juan Pablo Gulin
5622
mi
from 43215
Mar del Plata,
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Roel Querubin
423
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
Mesa, Arizona 85202
Principal Investigator: Daniel Kreutz
1654
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida
Principal Investigator: Juan Prieto
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
New Haven, Connecticut 06520
Principal Investigator: Fotios Koumpouras
537
mi
from 43215
New Haven, CT
Click here to add this to my saved trials
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
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
Phoenix, Arizona 85037
Principal Investigator: John Tesser
1671
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
Principal Investigator: Susan Manzi
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Plantation, Florida
Principal Investigator: Guillermo Valenzuela
969
mi
from 43215
Plantation, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
374
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63110
398
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
4650 Palm Avenue
San Diego, California 92154
Principal Investigator: Steve Lee
1948
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
San Leandro, California 94578
Principal Investigator: Suneet Grewal
2093
mi
from 43215
San Leandro, CA
Click here to add this to my saved trials
Seattle, Washington
Principal Investigator: Sergey Moiseev
2006
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana
Principal Investigator: Sarwat Umer
?
mi
from 43215
Shreveport, LA
Click here to add this to my saved trials
Syracuse, New York 13210
Principal Investigator: Andras Perl
415
mi
from 43215
Syracuse, NY
Click here to add this to my saved trials
Tampa, Florida 33613
Principal Investigator: Harris McIlwain
821
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Tampa, Florida
830
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
The Woodlands, Texas
Principal Investigator: Amber Khan
975
mi
from 43215
The Woodlands, TX
Click here to add this to my saved trials
Tomball, Texas 77375
Principal Investigator: Shaikh Ali
984
mi
from 43215
Tomball, TX
Click here to add this to my saved trials
Upland, California 91786
Principal Investigator: Antony Hou
1939
mi
from 43215
Upland, CA
Click here to add this to my saved trials
451 North Texas Avenue
Webster, Texas 77598
Principal Investigator: Abdelnaser Elkhalili
993
mi
from 43215
Webster, TX
Click here to add this to my saved trials
23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz
1988
mi
from 43215
West Hills, CA
Click here to add this to my saved trials