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 | 
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).
			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
    55
    sites
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									75 Francis street
Boston, Massachusetts 02115
	
			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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		SUNY Downstate Medical Center Formally known as The State University of New York Health Science...  
  
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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
	
			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
	
			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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									500 S State St
Ann Arbor, Michigan 48109
	
			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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									171 Ashley Avenue
Charleston, South Carolina 29425
	
			Charleston, South Carolina 29425
843-792-1414 
							 
					Principal Investigator: Elston Dirk
			
						
										Phone: 843-792-7191
					
		Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...  
  
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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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								Ciudad Autonoma Buenos Aires, Buenos Aires 			
	
			
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								Columbus, Ohio 43215			
	
			
					Principal Investigator: Benjamin Kaffenberger
			
						
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									2201 Inwood Rd
Dallas, Texas 75235
	
			Dallas, Texas 75235
(214) 645-8300
							 
					Principal Investigator: Benjamin Chong
			
						
								
		U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...  
  
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								Denver, Colorado 80230			
	
			
					Principal Investigator: Christopher Antolini
			
						
										Phone: 303-394-2828
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								El Cajon, California 92020			
	
			
					Principal Investigator: Arthur Mabaquiao
			
						
										Phone: 619-334-4735
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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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								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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									8860 Center Drive
La Mesa, California 92120
	
			
					La Mesa, California 92120
Principal Investigator: Roshan Kotha
			
						
										Phone: 619-229-1995
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									8290 West Sahara Avenue
Las Vegas, Nevada 89128
	
			
					Las Vegas, Nevada 89128
Principal Investigator: Craig Davis
			
						
										Phone: 702-489-4838
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									8930 South Sepulveda Boulevard
Los Angeles, California 90045
	
			
					Los Angeles, California 90045
Principal Investigator: Howard Sofen
			
						
										Phone: 310-337-7171
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									922 Southwest 82nd Avenue
Miami, Florida 33144
	
			
					Miami, Florida 33144
Principal Investigator: Nayvis Iglesias
			
						
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								Norfolk, Virginia 23507			
	
			
					Principal Investigator: David Pariser
			
						
										Phone: 757-625-0151
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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
	
			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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								Pittsburgh, Pennsylvania 15213			
	
			
					Principal Investigator: Laura Ferris
			
						
										Phone: 412-647-2013
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									223 N Van Dien Ave
Ridgewood, New Jersey 07450
	
			Ridgewood, New Jersey 07450
(201) 447-8000
							 
					Principal Investigator: Michael Gross
			
						
										Phone: 201-634-5465
					
		The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...  
  
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									660 S Euclid Ave
Saint Louis, Missouri 63110
	
			Saint Louis, Missouri 63110
(314) 362-5000 
							 
					Principal Investigator: Milan Anadkat
			
						
										Phone: 314-747-8693
					
		Washington University School of Medicine Washington University Physicians is the clinical practice of the School...  
  
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									5895 Windward Parkway
Sandy Springs, Georgia 30328
	
			
					Sandy Springs, Georgia 30328
Principal Investigator: Jaime Weisman
			
						
										Phone: 404-939-9220
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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
	
			
					West Hills, California 91307
Principal Investigator: Nazanin Firooz
			
						
										Phone: 818-598-0000
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									1907 Tradd Ct
Wilmington, North Carolina 28401
	
			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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