Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:October 20, 2016
End Date:November 12, 2019
Contact:US Biogen Clinical Trial Center
Email:clinicaltrials@biogen.com
Phone:866-633-4636

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A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

The primary purpose of the study is to evaluate the efficacy of BIIB059 in reducing disease
activity in participants with systemic lupus erythematosus (SLE) with active cutaneous
manifestations and joint involvement (Part A), and in participants with active cutaneous
lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE,
including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part
B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in
reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of
BIIB059 (Parts A and B).


Key Inclusion Criteria:

Part A:

1. Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the
1997 revised American College of Rheumatology (ACR) classification criteria for SLE
along with active skin manifestations and joint involvement.

2. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen
joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints
and/or wrist.

3. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous
lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or
chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus
(DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at
the time of Screening and randomization.

Part B:

1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index
Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has
been histologically confirmed (in the past or at Screening), with or without SLE
manifestations.

Key Exclusion Criteria:

1. Active lupus nephritis or moderate-to-severe or chronic kidney disease.

2. Any active skin conditions other than CLE that may interfere with the study (e.g.,
psoriasis, non-LE skin lupus, drug-induced lupus).

3. History of chronic, recurrent, or recent serious infection.

4. History of chronic, recurrent (3 or more of the same type of infection in a 12-month
period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as
determined by the Investigator and requiring anti-infective treatment within 12 weeks
prior to Screening.

5. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were
initiated less than 12 weeks prior to Randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
We found this trial at
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El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4735
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Joseph Merola
Phone: 617-732-4918
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
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Chapel Hill, North Carolina 27599
Principal Investigator: Saira Sheikh
Phone: 919-966-4191
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Seth Berney
Phone: 501-526-0366
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Principal Investigator: George Stoica
Phone: 407-426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Albuquerque, New Mexico 87102
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Yolanda Rosi-Helfrich
Phone: 734-936-4192
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Anniston, Alabama 36207
Principal Investigator: Vishala Chindalore
Phone: 256-236-0055
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Austin, Texas 78731
Principal Investigator: Tina Bunch
Phone: 512-344-0362
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Elston Dirk
Phone: 843-792-7191
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Charlotte, North Carolina 28204
Principal Investigator: Alireza Nami
Phone: 704-377-1216
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Charlotte, North Carolina 28207
Principal Investigator: Gary Maniloff
Phone: 704-342-0252
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Columbus, Ohio 43215
Principal Investigator: Benjamin Kaffenberger
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Benjamin Chong
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Denver, Colorado 80230
Principal Investigator: Christopher Antolini
Phone: 303-394-2828
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17271 Brookhurst Street
Fountain Valley, California 92708
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Great Neck, New York 11021
Principal Investigator: Richard Furie
Phone: 516-708-2559
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Greensboro, North Carolina 27408
Principal Investigator: Angela Hawkes
Phone: 336-501-1761
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Hemet, California 92453
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Houston, Texas
Principal Investigator: Philip Waller
Phone: 281-240-1045
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Houston, Texas 77098
Principal Investigator: Vijay Kumar
Phone: 713-333-9323
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Indianapolis, Indiana 46256
Principal Investigator: Scott Fretzin
Phone: 317-621-7731
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Irvine, California 92697
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La Jolla, California 92037
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8860 Center Drive
La Mesa, California 92120
Principal Investigator: Roshan Kotha
Phone: 619-229-1995
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8290 West Sahara Avenue
Las Vegas, Nevada 89128
Principal Investigator: Craig Davis
Phone: 702-489-4838
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8930 South Sepulveda Boulevard
Los Angeles, California 90045
Principal Investigator: Howard Sofen
Phone: 310-337-7171
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922 Southwest 82nd Avenue
Miami, Florida 33144
Principal Investigator: Nayvis Iglesias
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Miami Lakes, Florida 33014
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Norfolk, Virginia 23507
Principal Investigator: David Pariser
Phone: 757-625-0151
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North Charleston, South Carolina 29406
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Orlando, Florida 32804
Principal Investigator: Sanjiv Kapil
Phone: 407-988-1075
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Victoria Werth
Phone: 215-662-2737
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85032
Principal Investigator: John Tesser
Phone: 480-443-8400
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Pinellas Park, Florida 33782
Principal Investigator: Arnaldo Torres
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Laura Ferris
Phone: 412-647-2013
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Pittsburgh, Pennsylvania 15260
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
Principal Investigator: Michael Gross
Phone: 201-634-5465
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Milan Anadkat
Phone: 314-747-8693
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San Diego, California 92123
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5895 Windward Parkway
Sandy Springs, Georgia 30328
Principal Investigator: Jaime Weisman
Phone: 404-939-9220
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1206 Coast Village Circle
Santa Barbara, California 93108
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Summit, New Jersey 07901
Principal Investigator: Neil Kramer
Phone: 908-598-7940
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Tustin, California 92780
Principal Investigator: Robin Dore
Phone: 714-505-5500
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Upland, California 91786
Principal Investigator: Eric Lee
Phone: 909-296-8700
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Washington, District of Columbia 20060
Principal Investigator: Mercedes Quinones
Phone: 202-865-3326
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Washington, District of Columbia 20037
Principal Investigator: Alison Ehrlich
Phone: 202-741-2625
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Washington, District of Columbia 20422
Principal Investigator: Mercedes Quinones
Phone: 202-865-3326
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23101 Sherman Place
West Hills, California 91307
Principal Investigator: Nazanin Firooz
Phone: 818-598-0000
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Principal Investigator: Ronald George
Phone: 910-815-6108
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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