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

NCT02847598 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 230LE2012015-004359-32
• Study Type: interventional
• Target: 264
• Locations: 12 countries
• Sites: 128

Brief Summary

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).

Conditions

Systemic Lupus Erythematosus; Active Cutaneous Lupus Erythematosus

Keywords

CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (34)

• Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24

  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

  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

  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

  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

  Week 24

Study Arms (6)

Part A: BIIB059 450 mg

EXPERIMENTAL

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)

Part A: Placebo

PLACEBO COMPARATOR

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

Part B: BIIB059 50 mg

EXPERIMENTAL

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)

Part B: BIIB059 150 mg

EXPERIMENTAL

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)

Part B: BIIB059 450 mg

EXPERIMENTAL

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)

Part B: Placebo

PLACEBO COMPARATOR

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

Interventions

BIIB059 (litifilimab) DRUG

Administered as specified in the treatment arm.

Also known as: litifilimab

Part A: BIIB059 450 mg; Part B: BIIB059 150 mg; Part B: BIIB059 450 mg; Part B: BIIB059 50 mg

Placebo DRUG

Administered as specified in the treatment arm.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (128)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

Location

Arizona Arthritis & Rheumatology

Phoenix, Arizona, 85037, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Tien Q Nguyen MD Inc

Fountain Valley, California, 92708, United States

Location

MD Med Corp

Hemet, California, 92543, United States

Location

Universtiy of California, Irvine

Irvine, California, 92697, United States

Location

The Regents of the University of California

La Jolla, California, 92037, United States

Location

Purushotham Akther & Rosan Kotha, MD Inc.

La Mesa, California, 92120, United States

Location

Dermatology Reserach Associates

Los Angeles, California, 90045, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

Richard Barthel, MD

Santa Barbara, California, 93108, United States

Location

Robin K. Dore, MD, Inc.

Tustin, California, 92780, United States

Location

Inland Rheumatology Clinical Trials Inc.

Upland, California, 91786, United States

Location

Nazanin Firooz, MD Inc.

West Hills, California, 91307, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Medical Faculty Associates, Inc.

Washington D.C., District of Columbia, 20037, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Clinical Research of West Florida- Corporate

Clearwater, Florida, 33765, United States

Location

Medical Research Center Of Miami

Miami, Florida, 33144, United States

Location

Lakes Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Omega Research Consultants

Orlando, Florida, 32804, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

DMI Research, Inc.

Pinellas Park, Florida, 33710, United States

Location

Advanced Medical Reserarch, PC

Sandy Springs, Georgia, 30328, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Davis Group, LTD

Las Vegas, Nevada, 89128, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

North Shore/Long Island Jewish PRIME

Great Neck, New York, 11020, United States

Location

Univeristy of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Joint and Muscle Research Institute

Charlotte, North Carolina, 28204, United States

Location

American Health Research, Inc.

Charlotte, North Carolina, 28207, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Ohio State University Clinical Trials

Columbus, Ohio, 43215, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Arthritis Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Low Country Rheumatology, PA

North Charleston, South Carolina, 29406, United States

Location

University of Tennessee Health Sciences Center

Memphis, Tennessee, 38104, United States

Location

Austin Regional Clinic, P.A.

Austin, Texas, 78731, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Accurate Clinical Research, Inc.

Houston, Texas, 77034, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

Research Site

Quilmes, Buenos Aires, B1878GEG, Argentina

Location

Research Site

Bueno Aires, Ciudad Autonoma Bueno Aires, C1015ABO, Argentina

Location

Research Site

Bueno Aires, Ciudad Autonoma Bueno Aires, C1046AAQ, Argentina

Location

Research Site

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Research Site

San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, C1056ABJ, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, C1221ADC, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, C1425AGC, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, C1425DKG, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, C1431FWO, Argentina

Location

Research Site

Córdoba, 5004, Argentina

Location

Research Site

Mendoza, 5500, Argentina

Location

Research Site

San Juan, 5400, Argentina

Location

Research Site

Pleven, 5800, Bulgaria

Location

Research Site

Plovdiv, 4000, Bulgaria

Location

Research Site

Plovdiv, 4002, Bulgaria

Location

Research Site

Rousse, 7000, Bulgaria

Location

Research Site

Rousse, 7002, Bulgaria

Location

Research Site

Shumen, 9700, Bulgaria

Location

Research Site

Sofia, 1407, Bulgaria

Location

Research Site

Sofia, 1431, Bulgaria

Location

Research Site

Sofia, 1463, Bulgaria

Location

Research Site

Sofia, 1606, Bulgaria

Location

Research Site

Barranquilla, 080020, Colombia

Location

Research Site

Barranquilla, 80020, Colombia

Location

Research Site

Bogotá, 110221, Colombia

Location

Research Site

Bogotá, 111211, Colombia

Location

Research Site

Bucaramanga, 680003, Colombia

Location

Research Site

Medellín, 050034, Colombia

Location

Research Site

Jerusalem, 9112001, Israel

Location

Research Site

Ramat Gan, 5265601, Israel

Location

Research Site

Saltillo, Coahuila, 25000, Mexico

Location

Research Site

Guadalajara, Jalisco, 44130, Mexico

Location

Research Site

Guadalajara, Jalisco, 44690, Mexico

Location

Research Site

Mexico City, Mexico City, 03100, Mexico

Location

Research Site

Mexico City, Mexico City, 06700, Mexico

Location

Research Site

Mexico City, Mexico City, 14080, Mexico

Location

Research Site

Morelia, Michoacán, 58260, Mexico

Location

Research Site

Cuernavaca, Morelos, 62290, Mexico

Location

Research Site

Monterrey, Neuvo Leon, 64000, Mexico

Location

Research Site

San Luis Potosí City, San Luis Potos, 78213, Mexico

Location

Research Site

San Luis Potosí City, San Luis Potos, 78240, Mexico

Location

Research Site

Mérida, Yucatán, 97070, Mexico

Location

Research Site

Durango, 34270, Mexico

Location

Research Site

Angeles City, Pampanga, 2009, Philippines

Location

Research Site

Batangas, 4127, Philippines

Location

Research Site

Cebu City, 6000, Philippines

Location

Research Site

Dasmariñas, 4114, Philippines

Location

Research Site

Davao City, 8000, Philippines

Location

Research Site

Iloilo City, 5000, Philippines

Location

Research Site

Makati City, 1229, Philippines

Location

Research Site

Manila, 1000, Philippines

Location

Research Site

Manila, 1008, Philippines

Location

Research Site

Quezon City, 1102, Philippines

Location

Research Site

Bydgoszcz, 85-168, Poland

Location

Research Site

Krakow, 30-033, Poland

Location

Research Site

Krakow, 30-363, Poland

Location

Research Site

Lodz, 90-436, Poland

Location

Research Site

Olsztyn, 10-117, Poland

Location

Research Site

Poznan, 60-529, Poland

Location

Research Site

Wroclaw, 50-368, Poland

Location

Research Site

Belgrade, 11000, Serbia

Location

Research Site

Niška Banja, 18205, Serbia

Location

Research Site

Šabac, 15000, Serbia

Location

Research Site

Suwon, Gyeonggi-do, 443-380, South Korea

Location

Research Site

Daejeon, 35233, South Korea

Location

Research Site

Changhua, 50004, Taiwan

Location

Research Site

Kaohsiung City, 824, Taiwan

Location

Research Site

Taipei, 100, Taiwan

Location

Research Site

Taoyuan District, 333, Taiwan

Location

Research Site

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Research Site

Pathum Thani, Klongluang, 12120, Thailand

Location

Research Site

Chiang Mai, Muang, 50200, Thailand

Location

Research Site

Khon Kaen, Muang, 40002, Thailand

Location

Research Site

Bangkok, Pathumwan, 10330, Thailand

Location

Related Publications (5)

• Cho SK, Vazquez T, Werth VP. Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus. Expert Opin Investig Drugs. 2023 May;32(5):345-353. doi: 10.1080/13543784.2023.2212154. Epub 2023 May 15.

  PMID: 37148249 DERIVED

• 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.

  PMID: 36069871 DERIVED

• 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.

  PMID: 35939578 DERIVED

• 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.

  PMID: 33687069 DERIVED

• 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.

  PMID: 32335844 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: July 28, 2016
• Study Start: October 20, 2016
• Primary Completion: August 28, 2019
• Study Completion: November 18, 2019
• Last Updated: November 7, 2023
• Results First Posted: May 15, 2023

Record last verified: 2023-10

Locations

US (53); AR (13); CO (6); ME (13); BU (10); SE (3); PL (7); KR (2); IL (2); TH (5); TW (4); PH (10)