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

Description

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).

Study Start Date

October, 20 2016

Estimated Completion Date

June 2019

Interventions

  • Drug: Placebo
  • Drug: BIIB059

Study ID

Biogen -- 230LE201

Status

Recruiting

Trial ID

NCT02847598

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

320

Sponsor

Biogen

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

Gender

All

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (115)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles None None None
North ShoreLong Island Jewish PRIME - Great Neck, New York 174.4 miles None None None
North ShoreLong Island Jewish PRIME - Great Neck, New York 174.4 miles None None None
North ShoreLong Island Jewish PRIME - Great Neck, New York 174.4 miles None None None
North ShoreLong Island Jewish PRIME - Great Neck, New York 174.4 miles None None None
Institute for Rheumatic Autoimmune diseases Overlook Medical Center - Summit, New Jersey 204.0 miles None None None
Institute for Rheumatic Autoimmune diseases Overlook Medical Center - Summit, New Jersey 204.0 miles None None None
Institute for Rheumatic Autoimmune diseases Overlook Medical Center - Summit, New Jersey 204.0 miles None None None
Institute for Rheumatic Autoimmune diseases Overlook Medical Center - Summit, New Jersey 204.0 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Howard University Hospital - Washington, D.C., District of Columbia 392.0 miles None None None
Howard University Hospital - Washington, D.C., District of Columbia 392.0 miles None None None
Howard University Hospital - Washington, D.C., District of Columbia 392.0 miles None None None
Howard University Hospital - Washington, D.C., District of Columbia 392.0 miles None None None
Virginia Clinical Research - Norfolk, Virginia 471.1 miles None None None
Virginia Clinical Research - Norfolk, Virginia 471.1 miles None None None
Virginia Clinical Research - Norfolk, Virginia 471.1 miles None None None
Virginia Clinical Research - Norfolk, Virginia 471.1 miles None None None
UPMC Arthritis Center - Pittsburgh, Pennsylvania 478.5 miles None None None
UPMC Arthritis Center - Pittsburgh, Pennsylvania 478.5 miles None None None
UPMC Arthritis Center - Pittsburgh, Pennsylvania 478.5 miles None None None
UPMC Arthritis Center - Pittsburgh, Pennsylvania 478.5 miles None None None
Univeristy of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
Univeristy of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
Univeristy of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
Univeristy of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
Ohio State University - Columbus, Ohio 632.7 miles None None None
Ohio State University - Columbus, Ohio 632.7 miles None None None
Ohio State University - Columbus, Ohio 632.7 miles None None None
Ohio State University - Columbus, Ohio 632.7 miles None None None
Medication Management LLC - Greensboro, North Carolina 636.9 miles None None None
Medication Management LLC - Greensboro, North Carolina 636.9 miles None None None
Medication Management LLC - Greensboro, North Carolina 636.9 miles None None None
Medication Management LLC - Greensboro, North Carolina 636.9 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan - Ann Arbor, Michigan 645.2 miles None None None
PMG Research of Wilmington LLC - Wilmington, North Carolina 674.5 miles None None None
PMG Research of Wilmington LLC - Wilmington, North Carolina 674.5 miles None None None
PMG Research of Wilmington LLC - Wilmington, North Carolina 674.5 miles None None None
PMG Research of Wilmington LLC - Wilmington, North Carolina 674.5 miles None None None
Joint and Muscle Research Institute - Charlotte, North Carolina 720.9 miles None None None
Joint and Muscle Research Institute - Charlotte, North Carolina 720.9 miles None None None
Joint and Muscle Research Institute - Charlotte, North Carolina 720.9 miles None None None
Joint and Muscle Research Institute - Charlotte, North Carolina 720.9 miles None None None
American Health Research Inc - Charlotte, North Carolina 721.9 miles None None None
American Health Research Inc - Charlotte, North Carolina 721.9 miles None None None
American Health Research Inc - Charlotte, North Carolina 721.9 miles None None None
American Health Research Inc - Charlotte, North Carolina 721.9 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Dawes Fretzin Clinical Research Group LLC - Indianapolis, Indiana 795.4 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Advanced Medical Reserarch PC - Atlanta, Georgia 929.9 miles None None None
Advanced Medical Reserarch PC - Atlanta, Georgia 929.9 miles None None None
Advanced Medical Reserarch PC - Atlanta, Georgia 929.9 miles None None None
Advanced Medical Reserarch PC - Atlanta, Georgia 929.9 miles None None None
Pinnacle Research Group LLC - Anniston, Alabama 1,000.0 miles None None None
Pinnacle Research Group LLC - Anniston, Alabama 1,000.0 miles None None None
Pinnacle Research Group LLC - Anniston, Alabama 1,000.0 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles None None None
Compass Research LLC - Orlando, Florida 1,118.6 miles None None None
Compass Research LLC - Orlando, Florida 1,118.6 miles None None None
Compass Research LLC - Orlando, Florida 1,118.6 miles None None None
Compass Research LLC - Orlando, Florida 1,118.6 miles None None None
Austin Regional Clinic PA - Austin, Texas 1,694.2 miles None None None
Austin Regional Clinic PA - Austin, Texas 1,694.2 miles None None None
Austin Regional Clinic PA - Austin, Texas 1,694.2 miles None None None
Austin Regional Clinic PA - Austin, Texas 1,694.2 miles None None None
Arizona Arthritis Rheumatology - Phoenix, Arizona 2,289.7 miles None None None
Arizona Arthritis Rheumatology - Phoenix, Arizona 2,289.7 miles None None None
Arizona Arthritis Rheumatology - Phoenix, Arizona 2,289.7 miles None None None
Arizona Arthritis Rheumatology - Phoenix, Arizona 2,289.7 miles None None None
Davis Group LTD - Las Vegas, Nevada 2,380.5 miles None None None
Davis Group LTD - Las Vegas, Nevada 2,380.5 miles None None None
Davis Group LTD - Las Vegas, Nevada 2,380.5 miles None None None
Davis Group LTD - Las Vegas, Nevada 2,380.5 miles None None None
Inland Rheumatology Clinical Trials Inc - Upland, California 2,563.9 miles None None None
Inland Rheumatology Clinical Trials Inc - Upland, California 2,563.9 miles None None None
Inland Rheumatology Clinical Trials Inc - Upland, California 2,563.9 miles None None None
Inland Rheumatology Clinical Trials Inc - Upland, California 2,563.9 miles None None None
Purushotham Akther Rosan Kotha MD Inc - San Diego, California 2,575.9 miles None None None
Purushotham Akther Rosan Kotha MD Inc - San Diego, California 2,575.9 miles None None None
Purushotham Akther Rosan Kotha MD Inc - San Diego, California 2,575.9 miles None None None
Purushotham Akther Rosan Kotha MD Inc - San Diego, California 2,575.9 miles None None None
The University of California - La Jolla, California 2,581.5 miles None None None
The University of California - La Jolla, California 2,581.5 miles None None None
The University of California - La Jolla, California 2,581.5 miles None None None
The University of California - La Jolla, California 2,581.5 miles None None None
Robin K Dore MD Inc - Tustin, California 2,583.7 miles None None None
Robin K Dore MD Inc - Tustin, California 2,583.7 miles None None None
Robin K Dore MD Inc - Tustin, California 2,583.7 miles None None None
Robin K Dore MD Inc - Tustin, California 2,583.7 miles None None None
Dermatology Reserach Associates - Los Angeles, California 2,606.2 miles None None None
Dermatology Reserach Associates - Los Angeles, California 2,606.2 miles None None None
Dermatology Reserach Associates - Los Angeles, California 2,606.2 miles None None None
Dermatology Reserach Associates - Los Angeles, California 2,606.2 miles None None None
Nazanin Firooz MD Inc - West Hills, California 2,611.9 miles None None None
Nazanin Firooz MD Inc - West Hills, California 2,611.9 miles None None None
Nazanin Firooz MD Inc - West Hills, California 2,611.9 miles None None None
Nazanin Firooz MD Inc - West Hills, California 2,611.9 miles None None None

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