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

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ClinicalTrials.gov Identifier: NCT02847598

Recruitment Status : Completed

First Posted : July 28, 2016

Last Update Posted : September 2, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Biogen

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Systemic Lupus Erythematosus Active Cutaneous Lupus Erythematosus	Drug: BIIB059 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	264 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	October 20, 2016
Actual Primary Completion Date :	August 28, 2019
Actual Study Completion Date :	November 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Systemic lupus erythematosus

MedlinePlus related topics: Lupus

Genetic and Rare Diseases Information Center resources: Cutaneous Lupus Erythematosus

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part A: BIIB059 450 mg BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with systemic lupus erythematosus [SLE] with active skin manifestations and joint involvement.	Drug: BIIB059 Administered as specified in the treatment arm.
Placebo Comparator: Part A: Placebo BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with [SLE] with active skin manifestations and joint involvement.	Drug: Placebo Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 50 mg BIIB059 50 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active cutaneous lupus erythematosus [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 150 mg BIIB059 150 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Experimental: Part B: BIIB059 450 mg BIIB059 450 mg administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: BIIB059 Administered as specified in the treatment arm.
Placebo Comparator: Part B: Placebo BIIB059 matching placebo administered subcutaneously (SC) every 4 weeks (Q4W) with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active [CLE] with or without systemic manifestations.	Drug: Placebo Administered as specified in the treatment arm.

Outcome Measures

Primary Outcome Measures :

Part A: Change from Baseline in Active Joint Count (28-joint Assessment) to Week 24 [ Time Frame: Baseline, Week 24 ]
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Part B: Percent Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 [ Time Frame: Baseline, Week 16 ]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.

Secondary Outcome Measures :

Percentage of Participants with CLASI-50 Response at Week 24 (Part A) and Weeks 12 and 16 (Part B) [ Time Frame: Baseline up to Week 24 ]
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24 (Part A) and Weeks 12 and 16 (Part B).

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percent Change from Baseline in CLASI-A Score to Weeks 12, 16, and 24 (Part A) and Week 12 (Part B) [ Time Frame: Baseline up to Week 24 ]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percentage of Participants with a ≥ 4-point reduction in CLASI-A score Relative to Baseline at Weeks 12 and 16 (Part B), and Week 24 (Part A) [ Time Frame: Baseline up to Week 24 ]
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively.
Percentage of Participants with a Composite Response (Part A) [ Time Frame: Baseline, Week 24 ]
Composite response is defined as:

Participants with a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) of ≥4 (SRI-4) at Week 24. SRI-4 is defined as a reduction from baseline of ≥4 points in SLE Disease Activity Index 2000 (SLEDAI-2K). Participants will also have no new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. No worsening from baseline in the participant's lupus disease activity is to be present, defined by <0.3 point increase in Physician's Global Assessment (PGA) visual analogue scale (VAS). Lastly, the participants will have no protocol-prohibited medication or treatment, concomitant corticosteroid dosage at Week 24 is <=10 mg/day, concomitant corticosteroid dosage at Week 24 is <=Day 1 corticosteroid dosage, and there is to be no increase in corticosteroid dose between Weeks 17 and 24.
Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score to Week 24 (Part A) [ Time Frame: Baseline, Week 24 ]
The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
Percentage of Participants with no New Organ System Affected (Part A) [ Time Frame: Baseline, Week 24 ]
No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B.
Change from baseline in Physician's Global Assessment (PGA) visual analog scale (VAS) score (Part A) [ Time Frame: Baseline, Week 24 ]
BIIB059 Clearance [ Time Frame: Up to Week 36 ]
BIIB059 Volume of Distribution [ Time Frame: Up to Week 36 ]
BIIB059 Absorption Rate [ Time Frame: Up to Week 36 ]
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 36 weeks ]
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Number of Participants with Clinically Significant Laboratory Assessment Abnormalities [ Time Frame: Up to Week 36 ]
Number of Participants with Clinically Significant Vital Sign Abnormalities [ Time Frame: Up to Week 36 ]
Number of Participants with Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities [ Time Frame: Up to Week 36 ]
Number of Participants with Positive Serum BIIB059 Antibodies [ Time Frame: Up to Week 36 ]
Absolute Change From Baseline Over Time in Immunoglobulin Levels [ Time Frame: Up to Week 36 ]
Absolute Change From Baseline Over Time in Vaccine Titers [ Time Frame: Up to Week 36 ]
Percent Change From Baseline Over Time in Immunoglobulin Levels [ Time Frame: Up to Week 36 ]
Percent Change From Baseline Over Time in Vaccine Titers [ Time Frame: Up to Week 36 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Part A:

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.
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.
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:

Active lupus nephritis or moderate-to-severe or chronic kidney disease.
Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
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.
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847598

Locations

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United States, Alabama
Pinnacle Research Group LLC
Anniston, Alabama, United States, 36207
United States, Arizona
Arizona Arthritis & Rheumatology
Phoenix, Arizona, United States, 85037
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
TriWest Research Associates, LLC
El Cajon, California, United States, 92020
Tien Q Nguyen MD Inc
Fountain Valley, California, United States, 92708
MD Med Corp
Hemet, California, United States, 92543
Universtiy of California, Irvine
Irvine, California, United States, 92697
The Regents of the University of California
La Jolla, California, United States, 92037
Purushotham Akther & Rosan Kotha, MD Inc.
La Mesa, California, United States, 92120
Dermatology Reserach Associates
Los Angeles, California, United States, 90045
University Clinical Trials
San Diego, California, United States, 92123
Richard Barthel, MD
Santa Barbara, California, United States, 93108
Robin K. Dore, MD, Inc.
Tustin, California, United States, 92780
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States, 91786
Nazanin Firooz, MD Inc.
West Hills, California, United States, 91307
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, District of Columbia
Medical Faculty Associates, Inc.
Washington, District of Columbia, United States, 20037
Howard University Hospital
Washington, District of Columbia, United States, 20060
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
United States, Florida
Clinical Research of West Florida- Corporate
Clearwater, Florida, United States, 33765
Lakes Research, LLC
Miami Lakes, Florida, United States, 33014
Medical Research Center Of Miami
Miami, Florida, United States, 33144
Omega Research Consultants
Orlando, Florida, United States, 32804
Compass Research, LLC
Orlando, Florida, United States, 32806
DMI Research, Inc.
Pinellas Park, Florida, United States, 33710
United States, Georgia
Advanced Medical Reserarch, PC
Sandy Springs, Georgia, United States, 30328
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83642
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Davis Group, LTD
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Valley Hospital
Ridgewood, New Jersey, United States, 07450
Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center
Summit, New Jersey, United States, 07901
United States, New Mexico
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States, 87102
United States, New York
North Shore/Long Island Jewish PRIME
Great Neck, New York, United States, 11020
United States, North Carolina
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
American Health Research, Inc.
Charlotte, North Carolina, United States, 28207
Medication Management, LLC
Greensboro, North Carolina, United States, 27408
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
United States, Ohio
Ohio State University Clinical Trials
Columbus, Ohio, United States, 43215
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Arthritis Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Low Country Rheumatology, PA
North Charleston, South Carolina, United States, 29406
United States, Tennessee
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38104
United States, Texas
Austin Regional Clinic, P.A.
Austin, Texas, United States, 78731
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Accurate Clinical Research, Inc.
Houston, Texas, United States, 77034
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
United States, Virginia
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
Argentina
Research Site
Quilmes, Buenos Aires, Argentina, B1878GEG
Research Site
Bueno Aires, Ciudad Autonoma Bueno Aires, Argentina, C1015ABO
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Bueno Aires, Ciudad Autonoma Bueno Aires, Argentina, C1046AAQ
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San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
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San Miguel de Tucuman, Tucuman, Argentina, T4000BRD
Research Site
Ciudad Autonoma Buenos Aires, Argentina, C1056ABJ
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Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
Research Site
Ciudad Autonoma Buenos Aires, Argentina, C1425AGC
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Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
Research Site
Ciudad Autonoma Buenos Aires, Argentina, C1431FWO
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Cordoba, Argentina, 5004
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Mendoza, Argentina, 5500
Research Site
San Juan, Argentina, 5400
Bulgaria
Research Site
Pleven, Bulgaria, 5800
Research Site
Plovdiv, Bulgaria, 4000
Research Site
Plovdiv, Bulgaria, 4002
Research Site
Ruse, Bulgaria, 7000
Research Site
Ruse, Bulgaria, 7002
Research Site
Shumen, Bulgaria, 9700
Research Site
Sofia, Bulgaria, 1407
Research Site
Sofia, Bulgaria, 1431
Research Site
Sofia, Bulgaria, 1463
Research Site
Sofia, Bulgaria, 1606
Colombia
Research Site
Barranquilla, Colombia, 080020
Research Site
Barranquilla, Colombia, 80020
Research Site
Bogota, Colombia, 110221
Research Site
Bogota, Colombia, 111211
Research Site
Bucaramanga, Colombia, 680003
Research Site
Medellín, Colombia, 050034
Israel
Research Site
Jerusalem, Israel, 9112001
Research Site
Ramat Gan, Israel, 5265601
Korea, Republic of
Research Site
Suwon-Si, Gyeonggi-do, Korea, Republic of, 443-380
Research Site
Daejeon, Korea, Republic of, 35233
Mexico
Research Site
Saltillo, Coahuila, Mexico, 25000
Research Site
Mexico, Distrito Federal, Mexico, 03100
Research Site
Mexico, Distrito Federal, Mexico, 06700
Research Site
Mexico, Distrito Federal, Mexico, 14080
Research Site
Guadalajara, Jalisco, Mexico, 44130
Research Site
Guadalajara, Jalisco, Mexico, 44690
Research Site
Morelia, Michoacán, Mexico, 58260
Research Site
Cuernavaca, Morelos, Mexico, 62290
Research Site
Monterrey, Neuvo Leon, Mexico, 64000
Research Site
San Luis Potosi, San Luis Potos, Mexico, 78213
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San Luis Potosi, San Luis Potos, Mexico, 78240
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Merida, Yucatan, Mexico, 97070
Research Site
Durango, Mexico, 34270
Philippines
Research Site
Angeles City, Pampanga, Philippines, 2009
Research Site
Batangas, Philippines, 4127
Research Site
Cebu City, Philippines, 6000
Research Site
Dasmarinas, Philippines, 4114
Research Site
Davao City, Philippines, 8000
Research Site
Iloilo City, Philippines, 5000
Research Site
Iloilo, Philippines, 5000
Research Site
Makati City, Philippines, 1229
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Manila, Philippines, 1000
Research Site
Manila, Philippines, 1008
Research Site
Quezon City, Philippines, 1102
Poland
Research Site
Bydgoszcz, Poland, 85-168
Research Site
Krakow, Poland, 30-033
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Krakow, Poland, 30-363
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Lodz, Poland, 90-436
Research Site
Olsztyn, Poland, 10-117
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Poznan, Poland, 60-529
Research Site
Wroclaw, Poland, 50-368
Serbia
Research Site
Belgrade, Serbia, 11000
Research Site
Niska Banja, Serbia, 18205
Research Site
Sabac, Serbia, 15000
Taiwan
Research Site
Changhua, Taiwan, 50004
Research Site
Kaohsiung, Taiwan, 824
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Taipei, Taiwan, 100
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Taoyuan, Taiwan, 333
Thailand
Research Site
Pathum Thani, Klongluang, Thailand, 12120
Research Site
Chiang Mai, Muang, Thailand, 50200
Research Site
Khon Kaen, Muang, Thailand, 40002
Research Site
Bangkok, Pathumwan, Thailand, 10330
Research Site
Hat Yai, Songkhla, Thailand, 90110

Sponsors and Collaborators

Biogen

Investigators

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Study Director:	Medical Director	Biogen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Furie RA, van Vollenhoven RF, Kalunian K, Navarra S, Romero-Diaz J, Werth VP, Huang X, Clark G, Carroll H, Meyers A, Musselli C, Barbey C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus. N Engl J Med. 2022 Sep 8;387(10):894-904. doi: 10.1056/NEJMoa2118025.

Werth VP, Furie RA, Romero-Diaz J, Navarra S, Kalunian K, van Vollenhoven RF, Nyberg F, Kaffenberger BH, Sheikh SZ, Radunovic G, Huang X, Clark G, Carroll H, Naik H, Gaudreault F, Meyers A, Barbey C, Musselli C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus. N Engl J Med. 2022 Jul 28;387(4):321-331. doi: 10.1056/NEJMoa2118024.

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Hartmann S, Biliouris K, Naik H, Rabah D, Stevenson L, Shen C, Nestorov IA, Lesko LJ, Trame MN. A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus. J Pharmacokinet Pharmacodyn. 2020 Jun;47(3):255-266. doi: 10.1007/s10928-020-09688-y. Epub 2020 Apr 25.

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Responsible Party:	Biogen
ClinicalTrials.gov Identifier:	NCT02847598
Other Study ID Numbers:	230LE201 2015-004359-32 ( EudraCT Number )
First Posted:	July 28, 2016 Key Record Dates
Last Update Posted:	September 2, 2020
Last Verified:	August 2020

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Biogen:


CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Lupus

Additional relevant MeSH terms:

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Lupus Erythematosus, Systemic Lupus Erythematosus, Cutaneous Connective Tissue Diseases	Autoimmune Diseases Immune System Diseases Skin Diseases

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