A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

NCT06044337 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 2 other identifiers: 230LE3052023-504863-17-00
• Study Type: interventional
• Target: 322
• Locations: 24 countries
• Sites: 103

Brief Summary

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are unwanted health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows:

• The last visit of parent study 230LE301 will be the first visit of study 230LE305.
• All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug.
• Globally, the treatment period will last up to 104 weeks, or 2 years. For participants in the United States, the treatment period may last up to 260 weeks, or 5 years
• There will be a follow-up safety period that lasts up to 24 weeks.
• Globally, participants will have up to 27 study visits during the treatment period. In the US, participants will have up to 66 study visits.
• Globally, the total study duration for participants will be up to 128 weeks. In the US, the total study duration will be up to 284 weeks .

Conditions

Chronic Cutaneous Lupus Erythematosus; Subacute Cutaneous Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 128 weeks

Secondary Outcomes (41)

• Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

  Up to 128 weeks

• Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

  Up to 128 weeks

• Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

  Up to 128 weeks

• Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

  Up to 128 weeks

• Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1

  Up to 128 weeks

Study Arms (1)

BIIB059

EXPERIMENTAL

Participants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 100 in the LTE period. Following the 2 year long-term extension (LTE) period, participants in the USA will receive BIIB059 (litifilimab), once every 4 weeks up to Week 256.

Drug: BIIB059 (litifilimab)

Interventions

BIIB059 (litifilimab) DRUG

Administered as specified in the treatment arm.

Also known as: litifilimab

BIIB059

Eligibility Criteria

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

You may qualify if:

• Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
• Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.

You may not qualify if:

• Early Part A or Part B parent study (230LE301 \[NCT05531565\]) treatment terminators (participants who discontinued study treatment before Week 48).
• Early Part A or Part B parent study terminators \[participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)\].
• Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.

Sponsors & Collaborators

• Biogen: lead

Study Sites (104)

University of Alabama at Birmingham - (UAB)

Birmingham, Alabama, 35233, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, 85032, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

Location

David Fivenson, MD, Dermatology, PLLC

Ann Arbor, Michigan, 48103, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599-7280, United States

Location

Duke Dermatology South Durham

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Health Physicians Office Dermatology

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-8896, United States

Location

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas, 76034, United States

Location

Instituto CAICI

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

APRILLUS Asistencia e Investigacion

Buenos Aires, C1406AGA, Argentina

Location

Clínica SER da Bahia

Salvador, Estado de Bahia, 40150-150, Brazil

Location

L2IP - Instituto de Pesquisas Clínicas Ltda.

Brasília, Federal District, 70200-730, Brazil

Location

IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

Santo Ângelo, Mato Grosso, 78020-500, Brazil

Location

CMiP - Centro Mineiro de Pesquisa

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

LMK Serviços Médicos S/S Ltda

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

São Paulo, São Paulo, 04266-010, Brazil

Location

IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

Rio de Janeiro, 22470-220, Brazil

Location

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, Sofia City Province, 1612, Bulgaria

Location

DCC 'Alexandrovska', EOOD

Sofia, 1431, Bulgaria

Location

DCC Focus 5 - MEOH OOD

Sofia, 1463, Bulgaria

Location

Laser Rejuvenation Clinics, Inc.

Calgary, Alberta, T2W 4X9, Canada

Location

DIEX Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Centro Medico SkinMed

Las Condes, 7580206, Chile

Location

CIEC - Centro Internacional de Estudios Clínicos

Santiago, 8420383, Chile

Location

Clinical Research Chile SpA

Valdivia, 5090000, Chile

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518029, China

Location

Dongguan People's Hospital

Dongguan, Guangdongsheng, 523059, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdongsheng, 510515, China

Location

The second Xiangya Hospital of Central South University

Changsha, Húnánsheng, 410011, China

Location

Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shànghaishì, 200443, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yun'Nan, 650101, China

Location

Healthy Medical Center

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Centro de Investigacion Medico Asistencial S.A.S

Barranquilla, 80020, Colombia

Location

CHU de Caen - Hopital de la Cote de Nacre

Caen, Calvados, 14033, France

Location

Hopital Larrey

Toulouse, Haute Garonne, 31059, France

Location

Hopital Saint Eloi

Montpellier, Herault, 34295, France

Location

Hopital Edouard Herriot - CHU Lyon

Lyon, Rhone, 69003, France

Location

Hopital Tenon

Paris, 75020, France

Location

Universitaetsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Klinikum Oldenburg AoeR

Oldenburg, Lower Saxony, 26133, Germany

Location

Universitaetsklinikum Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Halle (Saale)

Halle, Saxony-Anhalt, 06120, Germany

Location

Charité - Campus Charité Mitte

Berlin, 10117, Germany

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 07632, Hungary

Location

Università degli studi di Firenze

Florence, 50121, Italy

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

JCHO Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

NHO Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

University of Fukui Hospital

Yoshida-gun, Fukui, 910-1193, Japan

Location

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Kakogawa Central City Hospital

Kakogawa-shi, Hyōgo, 675-8611, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8501, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

Osaka Keisatsu Hospital

Osaka, Osaka, 543-8922, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo-To, 173-8606, Japan

Location

Clinstile, S.A. de C.V.

Mexico City, Mexico City, 06700, Mexico

Location

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, 31000, Mexico

Location

Centro de investigacion medica y reumatologia

Guadalajara, 44950, Mexico

Location

Mary Mediatrix Medical Center

Lipa City, Batangas, 4127, Philippines

Location

Lorma Medical Center

San Fernando City, La Union, La Union, 2500, Philippines

Location

St. Luke's Medical Center

Quezon City, National Capital Region (ncr), 1102, Philippines

Location

University of the Philippines Manila - Philippine General Hospital

Manila, 1000, Philippines

Location

Jose R. Reyes Memorial Medical Center

Manila, 1012, Philippines

Location

Royalderm_Warszawa

Warsaw, Masovian Voivodeship, 02-962, Poland

Location

Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)

Coimbra, Coimbra District, 3000-075, Portugal

Location

Institute of Rheumatology_Belgrade

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Artromac n.o.

Košice, 04011, Slovakia

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Hospital Universitario Rio Hortega

Valladolid, Cantabria, 47012, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Karolinska Universitetssjukhuset - Solna

Solna, 17000, Sweden

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Lucerne (Luzern), CH-1011, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Whipps Cross University Hospital

London, Greater London, E11 1NR, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

Chapel Allerton Hospital

Chapel Allerton, West Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Discoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 21, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): June 26, 2029
• Study Completion (Estimated): December 11, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (14); AR (4); CN (8); FR (5); SE (2); ES (6); DE (7); CH (2); US (13); SL (1); CA (2); PT (1); PL (2); PH (5); IT (2); CL (3); BR (9); ME (3); BU (3); GB (3); HU (1); CO (2); TW (2); KR (3)