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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Washington, District of Columbia 20060
Principal Investigator: Mercedes Quinones
Phone: 202-865-3326
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75 Francis street
Boston, Massachusetts 02115
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450 Clarkson Avenue
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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Phone: 501-526-0366
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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Albuquerque, New Mexico 87102
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500 S State St
Ann Arbor, Michigan 48109
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Anniston, Alabama 36207
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Austin, Texas 78731
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28207
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2201 Inwood Rd
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Denver, Colorado 80230
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Greensboro, North Carolina 27408
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Hemet, California 92453
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Houston, Texas 77098
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Indianapolis, Indiana 46256
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8860 Center Drive
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8290 West Sahara Avenue
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8930 South Sepulveda Boulevard
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922 Southwest 82nd Avenue
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Miami Lakes, Florida 33014
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Norfolk, Virginia 23507
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North Charleston, South Carolina 29406
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3451 Walnut St
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223 N Van Dien Ave
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660 S Euclid Ave
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1206 Coast Village Circle
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Washington, District of Columbia 20037
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Washington, District of Columbia 20422
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23101 Sherman Place
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1907 Tradd Ct
Wilmington, North Carolina 28401
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