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

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 (litifilimab) 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 Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus; Active Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: BIIB059 (litifilimab)

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (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.
4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: BIIB059 450 mg; BIIB059 450 mg administered SC, 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: BIIB059 (litifilimab); Administered as specified in the treatment arm.; Other Names: litifilimab
Placebo Comparator: Part A: Placebo; BIIB059 matching placebo administered SC, Q4W with an additional dose at Week 2 for 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 SC, 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 (litifilimab); Administered as specified in the treatment arm.; Other Names: litifilimab
Experimental: Part B: BIIB059 150 mg; BIIB059 150 mg administered SC, 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 (litifilimab); Administered as specified in the treatment arm.; Other Names: litifilimab
Experimental: Part B: BIIB059 450 mg; BIIB059 450 mg administered, 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 (litifilimab); Administered as specified in the treatment arm.; Other Names: litifilimab
Placebo Comparator: Part B: Placebo; BIIB059 matching placebo administered SC, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.	Baseline to Week 24
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to 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. Higher scores indicate more disease activity.	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity.	Week 24
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16	CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity.	Week 12, Week 16
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity.	Baseline, Week 12, 16 and 24
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity.	Baseline, Week 12
Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.	Week 24
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.	Week 12, Week 16
Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.	Week 24
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	The CLASI is a clinical tool that quantifies disease activity and damage in 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. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.	Week 12, Week 16
Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24	An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a <1-point increase in the PGA (VAS) [on a scale of 0 to 10],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.	Week 24
Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at 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), where higher scores representing increased disease activity.	Baseline to Week 24
Part A: Percentage of Participants With no New Organ System Affected at 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. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.	Week 24
Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24	The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.	Baseline to Week 24
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant 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 participant 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.	Baseline up to Week 36
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant or clinical investigation participant 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 participant 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.	Baseline up to Week 28
Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities		Baseline up to Week 36
Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities		Baseline up to Week 28
Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities		Baseline up to Week 36
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities		Baseline up to Week 28
Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities		Baseline up to Week 36
Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities		Baseline up to Week 28
Part A: Number of Participants With Positive BIIB059 Antibodies		Baseline up to Week 24
Part B: Number of Participants With Positive BIIB059 Antibodies		Baseline up to Week 16
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels		Baseline up to Week 24
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels		Baseline up to Week 16
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24	Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.	Baseline to Week 24
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12	Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.	Baseline to Week 12
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24	Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).	Baseline to Week 24
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12	Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.	Baseline to Week 12
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels		Baseline up to Week 24
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels		Baseline up to Week 16
Part A: Percent Change From Baseline in Vaccine Titers at Week 24	Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody	Baseline to Week 24
Part B: Percent Change From Baseline in Vaccine Titers at Week 12	Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.	Baseline to Week 12
Part A: Serum Concentration of BIIB059		Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253
Part B: Serum Concentration of BIIB059		Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): August 28, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimated): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: 230LE201; 2015-004359-32 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes