Study on the Effectiveness and Safety of Litifilimab for Patients with Active Subacute or Chronic Cutaneous Lupus Erythematosus Resistant to Antimalarial Therapy

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What is this study about?

This clinical trial is focused on studying two types of lupus that affect the skin: Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus. These conditions can cause rashes and lesions on the skin, and sometimes they may also involve other parts of the body. The study is testing a new treatment called BIIB059, which is given as an injection. The purpose of the study is to evaluate how effective and safe BIIB059 is in reducing the activity of skin disease in people who have these types of lupus and have not responded well to antimalarial treatments.

Participants in the study will receive either the BIIB059 injection or a placebo, which looks like the treatment but does not contain the active ingredient. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ups to monitor the participants’ health and the effects of the treatment.

The trial is divided into two parts, and participants will be assessed using specific scores that measure the severity and activity of their skin condition. These scores help researchers understand how well the treatment is working. The study aims to provide valuable information about the potential benefits of BIIB059 for people with these challenging skin conditions. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

1 Joining the study

Upon joining the study, participation is confirmed through a diagnosis of cutaneous lupus erythematosus (CLE) with or without systemic symptoms. Active skin symptoms must meet specific criteria, including a CLASI-A score of 10 or higher.

Participants must have an active CLE lesion despite previous antimalarial treatment.

2 Initial assessment

An initial assessment is conducted to evaluate the severity of skin disease using the Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) score and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score.

3 Treatment administration

Participants receive either the active drug BIIB059 or a placebo. The medication is administered as a subcutaneous injection.

The treatment aims to reduce skin disease activity and is given according to the study’s schedule.

4 Monitoring and follow-up

Participants are monitored regularly to assess the effectiveness of the treatment. This includes measuring changes in the CLA-IGA-R and CLASI-A scores.

The primary goal is to achieve a significant reduction in skin disease activity by Week 16 and Week 24.

5 Long-term evaluation

The study continues to evaluate participants up to Week 52 to assess long-term effects and safety.

Secondary outcomes include changes in quality of life scores and the occurrence of any adverse events.

6 Completion of the study

The study is expected to conclude by December 2027, with final assessments and data collection completed by this time.

Who Can Join the Study?

  • You must have a confirmed diagnosis of Cutaneous Lupus Erythematosus (CLE), which is a skin condition, either in the past or during the screening period.
  • You must have active skin symptoms that meet the study’s specific requirements.
  • Your CLASI-A score must be 10 or higher. This score measures the severity of your skin condition.
  • You must have an active CLE skin lesion even after trying antimalarial treatment, which is a type of medication used to treat lupus.
  • Both males and females can participate in the study.
  • Other specific criteria defined by the study protocol may also apply.

Who Cannot Join the Study?

  • Participants who have other serious health conditions that might interfere with the study.
  • Individuals who are currently taking medications that could affect the study results.
  • People who have had a recent infection or illness that could impact their participation.
  • Participants who are pregnant or breastfeeding.
  • Individuals who have a history of allergic reactions to similar medications.
  • People who have participated in another clinical trial recently.
  • Participants who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Hopital Tenon Paris France
Hospital Vall d’Hebron Barcelona Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital Universitario da A Coruna A Coruna Galicia Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Assistance Publique Hopitaux De Marseille Marseille France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universitaetsklinikum Duesseldorf AöR Duesseldorf Germany
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centro Hospitalar E Universitario De Coimbra E.P.E. Coimbra Portugal
Universitaetsklinikum Muenster AöR Munster Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
Universitaetsklinikum Wuerzburg AöR Wuerzburg Germany
University Of Szeged Szeged Hungary
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Hospital Universitario Rio Hortega Valladolid Spain
Medical Center Medconsult Pleven OOD Pleven Bulgaria
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Royalderm Agnieszka Nawrocka Warsaw Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Besancon University Hospital Center Besançon France
Hospital General Universitario De Castellon Castello De La Plana Spain
University Of Pecs Pecs Hungary
Military Medical Academy Pleven Bulgaria
Martin-Luther-Universitaet Halle-Wittenberg Halle (Saale) Germany
Hospital Edouard Herriot Lyon France
Thermalsole und Schwefelbad Bentheim GmbH Bad Bentheim Germany
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d’Oncología (ICO) Badalona Spain
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria

Other Sites

Site Name City Country Status
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Artromac N.O. Kosice Slovakia
MICS Centrum Medyczne Warszawa Warsaw Poland
Ckzikxvoyg Purrqohtdie Lxwpsrijlmhllqtxaxkjntk Mnixxyzz sksiq Wroclaw Poland
Hnitnnt Pcdjz D Aitwem Antony France
Kywsbnxt Oexibwtyh Aqw Oldenburg In Holstein Germany
Mz Mwack Snxpbetyuepvngw Pmnqetvy Lkxhapve Tcymb Sgzgoaxhl Krosno Poland
Astz – Iiekt &rlwhyc Soqd Aiy Vmylglxm Dywthfwi Sofia Bulgaria
Lqfnld Mheepgcdvm Upopqqwsdo Ou Mruxly Munich Germany
Enoo Kizgnbit Smceayiscdnsung gpuob Buxtehude Germany
Hjtiwsrf Ckj Dwabdxebzhp Smge Lisbon Portugal
Pgmazr Pamlun Rcfdtwbtae Sff jz Cracow Poland
Deyxzskxaqf Aex Cwikzxokvsw Clzuia Shqdu Gkzcdf Etkd Haskovo Bulgaria
Dqt 1 Rzkn Eoxk Ruse Bulgaria
Mqynrexttkevh Hwfupitu fdx Akzywa Tafisggil Hjyxy aue Behpk Emu Pleven Bulgaria
Nrdfzub Uxwoz Rsisbjjdcwem Cucztc Piestany Slovakia
Sjlxrebmauazkxf gdvoqxq dfowkexmurpuqim Arxlrgxphotuzlsudbmu Mkkxw Bpzssiua Psytv Bnsiduau Sl Cracow Poland
Dpjxtjcxsukzvllaiydo Mlyokfir sawmq Mq Kfxdhrvxn Js Neilxyhq Ao Lglieb Lodz Poland
Drytqiei Jdnjp Zjqskrd Kielce Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.02.2022
Bulgaria Bulgaria
Not recruiting
02.02.2022
France France
Not recruiting
02.02.2022
Germany Germany
Not recruiting
02.02.2022
Hungary Hungary
Not recruiting
02.02.2022
Italy Italy
Not recruiting
02.02.2022
Poland Poland
Not recruiting
02.02.2022
Portugal Portugal
Not recruiting
02.02.2022
Slovakia Slovakia
Not recruiting
02.02.2022
Spain Spain
Not recruiting
02.02.2022
Sweden Sweden
Not recruiting
02.02.2022

Trial locations

Investigated Drugs:

BIIB059 is a medication being studied for its effectiveness in treating skin conditions related to lupus, specifically subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE). This medication is being tested to see if it can help reduce the activity of skin disease in patients who have not responded well to or cannot tolerate antimalarial treatments. The study aims to determine if BIIB059 can improve the condition of the skin by using specific assessment scores to measure changes in disease activity.

Subacute Cutaneous Lupus Erythematosus – This is a form of lupus that primarily affects the skin, causing red, scaly patches or ring-shaped lesions, often on sun-exposed areas. The condition can lead to skin sensitivity to sunlight and may result in discolored patches. It typically progresses with periods of flare-ups and remissions. Unlike systemic lupus, it usually does not affect internal organs. The skin lesions can heal without scarring but may leave behind areas of altered pigmentation.

Chronic Cutaneous Lupus Erythematosus – Also known as discoid lupus erythematosus, this condition is characterized by chronic skin lesions that are often red, inflamed, and can lead to scarring. These lesions typically appear on the face, scalp, and ears, and can cause permanent hair loss if they occur on the scalp. The disease progresses slowly, with lesions that can persist for long periods. It primarily affects the skin and rarely involves internal organs. The lesions may heal with scarring and changes in skin color.

Trial ID:
2023-505634-94-00
Protocol code:
230LE301
NCT ID:
NCT05531565
Trial Phase:
Therapeutic use (Phase IV)

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