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New hope for lupus skin sufferers: Long-Term drug trial launches

NCT ID NCT06044337

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This study tests the long-term safety of the drug litifilimab in adults with lupus skin disease (CLE) that didn't improve with standard antimalarial treatment. About 322 participants who completed a prior study will receive injections every 4 weeks for up to 2 years (or 5 years in the US). Researchers will track side effects and measure skin symptoms using standard scoring tools.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

chronic cutaneous lupus erythematosus cutaneous lupus erythematosus discoid lupus erythematosus subacute cutaneous lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic cutaneous lupus erythematosus Subacute cutaneous lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    104 sites in 25 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APRILLUS Asistencia e Investigacion

    Buenos Aires, C1406AGA, Argentina

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85032, United States

  • Artromac n.o.

    Košice, 04011, Slovakia

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730, China

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

    São Paulo, São Paulo, 04266-010, Brazil

  • CHU de Caen - Hopital de la Cote de Nacre

    Caen, Calvados, 14033, France

  • CIEC - Centro Internacional de Estudios Clínicos

    Santiago, 8420383, Chile

  • CMiP - Centro Mineiro de Pesquisa

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

  • Centre Hospitalier Universitaire Vaudois (CHUV)

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

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

    Coimbra, Coimbra District, 3000-075, Portugal

  • Centro Medico SkinMed

    Las Condes, 7580206, Chile

  • Centro de Investigacion Medico Asistencial S.A.S

    Barranquilla, 80020, Colombia

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centro de investigacion medica y reumatologia

    Guadalajara, 44950, Mexico

  • Chapel Allerton Hospital

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

  • Charité - Campus Charité Mitte

    Berlin, 10117, Germany

  • Clinical Research Chile SpA

    Valdivia, 5090000, Chile

  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City, 06700, Mexico

  • Clínica SER da Bahia

    Salvador, Estado de Bahia, 40150-150, Brazil

  • DCC 'Alexandrovska', EOOD

    Sofia, 1431, Bulgaria

  • DCC Focus 5 - MEOH OOD

    Sofia, 1463, Bulgaria

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8, Canada

  • David Fivenson, MD, Dermatology, PLLC

    Ann Arbor, Michigan, 48103, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Dongguan People's Hospital

    Dongguan, Guangdongsheng, 523059, China

  • Duke Dermatology South Durham

    Durham, North Carolina, 27710, United States

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, Lower Saxony, 48455, Germany

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Healthy Medical Center

    Zipaquirá, Cundinamarca, 250252, Colombia

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, Rhone, 69003, France

  • Hopital Larrey

    Toulouse, Haute Garonne, 31059, France

  • Hopital Saint Eloi

    Montpellier, Herault, 34295, France

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004, Spain

  • Hospital Universitario Rio Hortega

    Valladolid, Cantabria, 47012, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de Clínicas de Porto Alegre

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

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Hospital for Skin Diseases, Chinese Academy of Medical Sciences

    Nanjing, Jiangsu, 210042, China

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

    Rio de Janeiro, 22470-220, Brazil

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    Santo Ângelo, Mato Grosso, 78020-500, Brazil

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786, United States

  • Institute of Rheumatology_Belgrade

    Belgrade, 11000, Serbia

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua City, 31000, Mexico

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • JCHO Chukyo Hospital

    Nagoya, Aichi-ken, 457-8510, Japan

  • Jose R. Reyes Memorial Medical Center

    Manila, 1012, Philippines

  • Kakogawa Central City Hospital

    Kakogawa-shi, Hyōgo, 675-8611, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Karolinska Universitetssjukhuset - Solna

    Solna, 17000, Sweden

  • Klinikum Oldenburg AoeR

    Oldenburg, Lower Saxony, 26133, Germany

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556, Japan

  • L2IP - Instituto de Pesquisas Clínicas Ltda.

    Brasília, Federal District, 70200-730, Brazil

  • LMK Serviços Médicos S/S Ltda

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

  • Laser Rejuvenation Clinics, Inc.

    Calgary, Alberta, T2W 4X9, Canada

  • Lorma Medical Center

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

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4127, Philippines

  • NHO Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdongsheng, 510515, China

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Nucleo de Pesquisa Clinica do Rio Grande do Sul

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

  • Osaka Keisatsu Hospital

    Osaka, Osaka, 543-8922, Japan

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 07632, Hungary

  • Precision Comprehensive Clinical Research Solutions

    Grapevine, Texas, 76034, United States

  • Queen Elizabeth Hospital

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • Revival Research Institute, LLC

    Troy, Michigan, 48084, United States

  • Royalderm_Warszawa

    Warsaw, Masovian Voivodeship, 02-962, Poland

  • Saint Louis University

    St Louis, Missouri, 63110, United States

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, Shànghaishì, 200443, China

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518029, China

  • St. Luke's Medical Center

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

  • St. Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Taichung Veterans General Hospital

    Taichung, 407219, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Teikyo University Hospital

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

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

    Seoul, 06591, South Korea

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yun'Nan, 650101, China

  • The second Xiangya Hospital of Central South University

    Changsha, Húnánsheng, 410011, China

  • Thurston Arthritis Research Center

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

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8896, United States

  • Universitaetsklinikum Carl Gustav Carus TU

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, Sofia City Province, 1612, Bulgaria

  • University of Alabama at Birmingham - (UAB)

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Health Physicians Office Dermatology

    Cincinnati, Ohio, 45219, United States

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193, Japan

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of the Philippines Manila - Philippine General Hospital

    Manila, 1000, Philippines

  • Università degli studi di Firenze

    Florence, 50121, Italy

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Whipps Cross University Hospital

    London, Greater London, E11 1NR, United Kingdom

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.