Clinical trial • Phase II | Phase III • Immunology

LITIFILIMAB for Subacute cutaneous lupus erythematosus | Chronic cutaneous lupus erythematosus

Phase II | Phase III trial of LITIFILIMAB for Subacute cutaneous lupus erythematosus | Chronic cutaneous lupus erythematosus.

Overview

Trial Therapeutic Area: Immunology
Trial Disease: Subacute cutaneous lupus erythematosus | Chronic cutaneous lupus erythematosus
Trial Stage: Phase II | Phase III
Drug Modality: Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date: 14-02-2024
First CTIS Authorization Date: 19-03-2024

Trial design

Randomised, placebo (matching placebo formulation identical to biib059 drug product minus active ingredient) versus biib059 (litifilimab). doses/schedule not specified in the provided data.-controlled Phase II | Phase III trial in Belgium, Hungary, Bulgaria and others.

Randomised: Yes
Comparator: Placebo (matching placebo formulation identical to BIIB059 drug product minus active ingredient) versus BIIB059 (litifilimab). Doses/schedule not specified in the provided data.
Target Sample Size: 329
Trial Duration For Participant: 532

Eligibility

Recruits 329 No vulnerable populations selected. Informed consent obtained from adult participants (Adult Main ICF). Specific consent forms for pregnant participants/partners and optional consents are provided; no assent or minor-specific consent procedures are indicated in the provided materials..

Vulnerable Population: No vulnerable populations selected. Informed consent obtained from adult participants (Adult Main ICF). Specific consent forms for pregnant participants/partners and optional consents are provided; no assent or minor-specific consent procedures are indicated in the provided materials.

Inclusion criteria

{"criterion_text":"- 1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations."}
{"criterion_text":"- 2. Must have active cutaneous manifestations that meet study criteria."}
{"criterion_text":"- 3. Must have a CLASI-A score ≥10."}
{"criterion_text":"- 4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment."}
{"criterion_text":"- 5. NOTE: Other protocol defined Inclusion criteria may apply."}

Exclusion criteria

{"criterion_text":"- 1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE."}
{"criterion_text":"- 3. Active severe lupus nephritis."}
{"criterion_text":"- 4. Active neuropsychiatric SLE."}
{"criterion_text":"- 5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study."}
{"criterion_text":"- 6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose."}
{"criterion_text":"- 7. NOTE: Other protocol defined Exclusion criteria may apply."}
{"criterion_text":"- 2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren’s syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year."}

Endpoints

Primary endpoints

{"endpoint_text":"- Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1. Time frame: Week 16.","definition_or_measurement_approach":"Measured by CLA-IGA-R erythema component; response defined as CLA-IGA-R erythema score of 0 or 1 at Week 16 (Parts A and B US)."}
{"endpoint_text":"- Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline. Time frame: baseline to Week 24.","definition_or_measurement_approach":"CLASI-70 response defined as ≥70% decrease in CLASI-A score from baseline to Week 24 (Part B, ROW)."}

Secondary endpoints

{"endpoint_text":"- Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50%Decrease in CLASI-A Score From Baseline Time frame: Weeks 16 and 24.","definition_or_measurement_approach":"CLASI-50 defined as ≥50% decrease in CLASI-A from baseline; assessed at Weeks 16 and 24 (Part A)."}
{"endpoint_text":"- Part A (US+ROW): Absolute Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52. Time frame: Baseline to Week 52.","definition_or_measurement_approach":"Absolute change in CLASI-D from baseline to Week 52 (Part A)."}
{"endpoint_text":"- Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24.","definition_or_measurement_approach":"Proportion of FAS participants with CLA-IGA-R erythema score 0 or 1 at Weeks 16 and 24 among those with baseline CLA-IGA-R erythema ≥3 and OMC ≥3."}
{"endpoint_text":"- Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24.","definition_or_measurement_approach":"Proportion of FAS participants with CLA-IGA-R OMC score 0 or 1 at Weeks 16 and 24 among those with baseline CLA-IGA-R erythema ≥3 and OMC ≥3."}
{"endpoint_text":"- Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion with ≥1 level improvement in CLA-IGA-R erythema score from baseline up to Week 24."}
{"endpoint_text":"- Part B (US+ROW): Absolute Change in CLASI-D Score. Time frame: Week 52.","definition_or_measurement_approach":"Absolute change in CLASI-D at Week 52."}
{"endpoint_text":"- Part B (US+ROW): Percent Change in CLASI-D Score. Time frame: Week 52.","definition_or_measurement_approach":"Percent change in CLASI-D from baseline to Week 52."}
{"endpoint_text":"- Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16.","definition_or_measurement_approach":"CLASI-70 defined as ≥70% decrease in CLASI-A from baseline; assessed at specified timepoints."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1. Time frame: Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24.","definition_or_measurement_approach":"Proportion with CLA-IGA-R erythema score 0 or 1 at specified timepoints."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW):Up to Week 24.","definition_or_measurement_approach":"Proportion achieving CLA-IGA-R OMC 0 or 1 plus ≥1-level improvement from baseline at specified times."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.","definition_or_measurement_approach":"Proportion with CLA-IGA-R OMC score 0 at specified times."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.","definition_or_measurement_approach":"Proportion with ≥1-level improvement in CLA-IGA-R OMC from baseline at specified times."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0. Time frame: Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.","definition_or_measurement_approach":"Proportion achieving CLA-IGA-R follicular activity score 0 at specified times."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion with CLASI-A score 0 or 1 up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion with CLASI-A score between 0 and 3 up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion achieving ≥70% reduction in CLASI-A from baseline up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion achieving ≥50% reduction in CLASI-A from baseline up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score. Time frame: Up to Week 24.","definition_or_measurement_approach":"Proportion achieving a 7-point reduction in CLASI-A from baseline up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 AmongCLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP). Time frame: Week 52.","definition_or_measurement_approach":"Proportion of CLASI-70 responders at Week 16/24 who maintain response at Week 52 among those randomized to litifilimab during DBPC period."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP. Time frame: Week 52.","definition_or_measurement_approach":"Proportion with CLA-IGA-R erythema 0 or 1 at Week 52 among earlier responders who were randomized to BIIB059."}
{"endpoint_text":"- Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16and 24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52.","definition_or_measurement_approach":"Proportion with CLA-IGA-R OMC 0/1 and ≥1-level improvement at Week 52 among OMC responders at earlier timepoints randomized to litifilimab."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During the DBPC TP. Time frame: Week 52.","definition_or_measurement_approach":"Proportion with CLA-IGA-R OMC score 0 at Week 52 among those with OMC score 0 at Week 16/24 randomized to litifilimab."}
{"endpoint_text":"- Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52.","definition_or_measurement_approach":"Proportion with CLA-IGA-R follicular activity score 0 at Week 52 among earlier follicular responders randomized to litifilimab."}
{"endpoint_text":"- Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24. Time frame: Up to Week 24.","definition_or_measurement_approach":"Annualized rates of mild/moderate and severe SELENA-SLEDAI Flare Index (SFI) events through Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16. Time frame: Up to Week 16.","definition_or_measurement_approach":"Annualized SFI rates through Week 16."}
{"endpoint_text":"- Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52. Time frame: Up to Week 52.","definition_or_measurement_approach":"Annualized SFI rates through Week 52."}
{"endpoint_text":"- Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). Time frame: Up to Week 76.","definition_or_measurement_approach":"Counts of participants experiencing TEAEs and SAEs up to Week 76."}
{"endpoint_text":"- Percent Change in CLASI-D Score. Time Frame: Baseline to Week 52.","definition_or_measurement_approach":"Percent change in CLASI-D from baseline to Week 52."}
{"endpoint_text":"- Part B (US+ROW): Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.","definition_or_measurement_approach":"Change from baseline in NRS for skin rash pain at specified timepoints."}
{"endpoint_text":"- Part B (US+ROW): Change From Baseline in NRS for Itch in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.","definition_or_measurement_approach":"Change from baseline in NRS for itch at specified timepoints."}
{"endpoint_text":"- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 70 Response. Time Frame: Up to Week 24.","definition_or_measurement_approach":"Proportion achieving CLASI-70 up to Week 24."}
{"endpoint_text":"- Parts A and B (US+ROW): Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study. Time Frame: Up to Week 76","definition_or_measurement_approach":"Count of participants with anti-litifilimab antibodies in serum up to Week 76."}

Recruitment

Digital Remote Recruitment: Yes
Planned Sample Size: 329
Recruitment Window Months: 73
Consent Approach: Informed consent is obtained from adult participants via a Main ICF (Adult Main ICF). Multiple language versions of the ICFs and related subject information sheets are provided (examples in English, French, Italian, Portuguese, Bulgarian, Hungarian, Swedish, German, Slovak, Polish, Spanish, etc.). Specific optional consent forms are available (e.g., optional image/use-of-images consents, pregnant participant/partner information and consent forms). No assent procedures for minors are indicated in the provided materials.

Methods

Clinic posters (K2_Recruitment material_Clinic Poster files) — printed posters intended for clinic waiting rooms and dermatology departments; country/language-specific versions are documented (e.g., FR, NL, PL, BG, HU).
Study flyers / participant fliers (K2_Recruitment material_Study Flyer) — one-page informational leaflets for potential participants in clinic settings; language-specific versions available.
Patient information brochures / Clinical Trials Booklet (K2_Clinical Trials Booklet, Patient information brochure) — longer informational brochures provided to patients to explain study purpose and procedures; localized per country/language.
Patient database letters (K2_Recruitment material_Patient Database Letter) — letters to patients identified in site databases to invite participation.
Referral letters and Referral Fact Cards (K2_Recruitment material_Referral Letter / Referral Fact Card) — materials to enable GPs or other clinicians to refer suitable patients to study sites.
Investigator-facing materials (K2_Other Investigator material) — inclusion/exclusion cards and referral aids for site staff to support recruitment.
Site-based outreach and referral (K1_Recruitment arrangements / Recruitment and Informed Consent Procedure) — recruitment conducted via participating clinics/hospitals and investigator referral networks, with country-specific materials provided.
Retention and participant engagement materials (K2_Recruitment material_Retention items, Patient ID Card, Appointment Card) — printed items to support retention and study visits.

Geography

Total Number Of Sites: 78
Total Number Of Participants: 217

Belgium

Earliest CTIS Part Ii Submission Date: 25-08-2025
Latest Decision Or Authorization Date: 08-09-2025
Processing Time Days: 14
Number Of Sites: 4
Number Of Participants: 3

Sites

Site Name: Cliniques Universitaires Saint-Luc
Department Name: Dermatology
Principal Investigator Name: Pierre-Dominique Ghislain
Principal Investigator Email: pierre-dominique.ghislain@saintluc.uclouvain.be
Contact Person Name: Pierre-Dominique Ghislain
Contact Person Email: pierre-dominique.ghislain@saintluc.uclouvain.be

Site Name: UZ Leuven
Department Name: Dermatology
Principal Investigator Name: Petra De Haes
Principal Investigator Email: petra.dehaes@uzleuven.be
Contact Person Name: Petra De Haes
Contact Person Email: petra.dehaes@uzleuven.be

Site Name: Centre hospitalier universitaire de Liege
Department Name: Dermatology
Principal Investigator Name: Arjen Nikkels
Principal Investigator Email: af.nikkels@chuliege.be
Contact Person Name: Arjen Nikkels
Contact Person Email: af.nikkels@chuliege.be

Site Name: Universitair Ziekenhuis Gent
Department Name: Dermatology
Principal Investigator Name: Reinhart Speeckaert
Principal Investigator Email: reinhart.speeckaert@uzgent.be
Contact Person Name: Reinhart Speeckaert
Contact Person Email: reinhart.speeckaert@uzgent.be

Hungary

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 19-03-2024
Processing Time Days: 21
Number Of Sites: 3
Number Of Participants: 4

Sites

Site Name: University Of Pecs
Department Name: Bőr-, Nemikórtani és Onkodermatológiai Klinika
Principal Investigator Name: Anita Hanyecz
Principal Investigator Email: hanyecz.anita@pte.hu
Contact Person Name: Anita Hanyecz
Contact Person Email: hanyecz.anita@pte.hu

Site Name: University Of Szeged
Department Name: Bőrgyógyászati és Allergológiai Klinika
Principal Investigator Name: Rolland Gyulai
Principal Investigator Email: trial.office@szte.hu
Contact Person Name: Rolland Gyulai
Contact Person Email: trial.office@szte.hu

Site Name: Semmelweis University
Department Name: Bőr-Nemikórtani és Bőronkológiai Klinika
Principal Investigator Name: Péter Holló
Principal Investigator Email: hollo.peter@semmelweis.hu
Contact Person Name: Péter Holló
Contact Person Email: hollo.peter@semmelweis.hu

Bulgaria

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 23-04-2024
Processing Time Days: 56
Number Of Sites: 12
Number Of Participants: 18

Sites

Site Name: Diagnostic-Consultative Center Alexandrovska EOOD
Department Name: Not applicable
Principal Investigator Name: Petyo Brezoev
Principal Investigator Email: brezoev@gmail.com
Contact Person Name: Petyo Brezoev
Contact Person Email: brezoev@gmail.com

Site Name: Specialized Hospital For Active Treatment In Cardiology EAD
Department Name: Clinic of Dermatology and Venereal Diseases
Principal Investigator Name: Dimitar Gospodinov
Principal Investigator Email: dkg@abv.bg
Contact Person Name: Dimitar Gospodinov
Contact Person Email: dkg@abv.bg

Site Name: Medical Center Medconsult Pleven OOD
Department Name: Not applicable
Principal Investigator Name: Kamelia Vekovska
Principal Investigator Email: kvekovska_medconsult@abv.bg
Contact Person Name: Kamelia Vekovska
Contact Person Email: kvekovska_medconsult@abv.bg

Site Name: Dkc Fokus-5 Lzip OOD
Department Name: Not applicable
Principal Investigator Name: Grisha Mateev
Principal Investigator Email: grisha_mateev@yahoo.com
Contact Person Name: Grisha Mateev
Contact Person Email: grisha_mateev@yahoo.com

Site Name: Dcc 1 Sevlievo EOOD
Department Name: Not applicable
Principal Investigator Name: Dimitar Nikolov
Principal Investigator Email: dr.dimitar.nikolov@gmail.com
Contact Person Name: Dimitar Nikolov
Contact Person Email: dr.dimitar.nikolov@gmail.com

Site Name: Dkc Fokus-5 Lzip OOD
Department Name: Not applicable
Principal Investigator Name: Rumen Stoilov
Principal Investigator Email: rmstoilov@abv.bg
Contact Person Name: Rumen Stoilov
Contact Person Email: rmstoilov@abv.bg

Site Name: Military Medical Academy
Department Name: Department of Rheumatology
Principal Investigator Name: Boycho Oparanov
Principal Investigator Email: oparanov@abv.bg
Contact Person Name: Boycho Oparanov
Contact Person Email: oparanov@abv.bg

Site Name: Dkc 1 Ruse EOOD
Department Name: Not applicable
Principal Investigator Name: Nadezhda Kapandjieva
Principal Investigator Email: nely_kap@abv.bg
Contact Person Name: Nadezhda Kapandjieva
Contact Person Email: nely_kap@abv.bg

Site Name: Diagnostics And Consultancy Center Sveti Georgi EOOD
Department Name: Not applicable
Principal Investigator Name: Irida Vasileva
Principal Investigator Email: iridavasileva@gmail.com
Contact Person Name: Irida Vasileva
Contact Person Email: iridavasileva@gmail.com

Site Name: ASMC IPSMC Skin And Venereal Diseases
Department Name: Not applicable
Principal Investigator Name: Ivan Botev
Principal Investigator Email: botev2@yahoo.com
Contact Person Name: Ivan Botev
Contact Person Email: botev2@yahoo.com

Site Name: Diagnostic-Consultative Center Alexandrovska EOOD (second site entry)
Department Name: Not applicable
Principal Investigator Name: Snejina Vassileva
Principal Investigator Email: snejina.vassileva@gmail.com
Contact Person Name: Snejina Vassileva
Contact Person Email: snejina.vassileva@gmail.com

Site Name: Dcc 1 Sevlievo EOOD (additional listed site)
Department Name: Not applicable

Poland

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 26-03-2024
Processing Time Days: 28
Number Of Sites: 10
Number Of Participants: 14

Sites

Site Name: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name: Klinika Dermatologii
Principal Investigator Name: Lidia Rudnicka
Principal Investigator Email: lidiarudnicka@gmail.com
Contact Person Name: Lidia Rudnicka
Contact Person Email: lidiarudnicka@gmail.com

Site Name: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Principal Investigator Name: Jacek Szepiatowski
Principal Investigator Email: jacek.szepietowski@umed.wroc.pl
Contact Person Name: Jacek Szepiatowski
Contact Person Email: jacek.szepietowski@umed.wroc.pl

Site Name: Dermoklinika-Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
Principal Investigator Name: Joanna Narbutt
Principal Investigator Email: joanna.narbutt@onet.pl
Contact Person Name: Joanna Narbutt
Contact Person Email: joanna.narbutt@onet.pl

Site Name: Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SC
Principal Investigator Name: Paweł Brzewski
Principal Investigator Email: brzewski@gmail.com
Contact Person Name: Paweł Brzewski
Contact Person Email: brzewski@gmail.com

Site Name: Royalderm Agnieszka Nawrocka
Principal Investigator Name: Witold Owczarek
Principal Investigator Email: witold.owczarek@dermedicus.pl
Contact Person Name: Witold Owczarek
Contact Person Email: witold.owczarek@dermedicus.pl

Site Name: Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name: Klinika Dermatologii i Dermatologii Onkologicznej
Principal Investigator Name: Adam Reich
Principal Investigator Email: adamandrzejreich@gmail.com
Contact Person Name: Adam Reich
Contact Person Email: adamandrzejreich@gmail.com

Site Name: Promed P.Lach R.Glowacki Sp. j.
Principal Investigator Name: Ewa Górecka
Principal Investigator Email: badania.kliniczne@cmpromed.pl
Contact Person Name: Ewa Górecka
Contact Person Email: badania.kliniczne@cmpromed.pl

Site Name: MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński
Principal Investigator Name: Anna Rajchel
Principal Investigator Email: Kontakt@mtmedic.pl
Contact Person Name: Anna Rajchel
Contact Person Email: Kontakt@mtmedic.pl

Site Name: MICS Centrum Medyczne Warszawa
Principal Investigator Name: Katarzyna Romanowska-Próchnicka
Principal Investigator Email: malgorzatasocikpojawa@medycynakliniczna.pl
Contact Person Name: Katarzyna Romanowska-Próchnicka
Contact Person Email: malgorzatasocikpojawa@medycynakliniczna.pl

Site Name: Dermedic Jacek Zdybski
Principal Investigator Name: Jacek Zdybski
Principal Investigator Email: jacek@zdybski.pl
Contact Person Name: Jacek Zdybski
Contact Person Email: jacek@zdybski.pl

Portugal

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 19-03-2024
Processing Time Days: 21
Number Of Sites: 3
Number Of Participants: 6

Sites

Site Name: Hospital Cuf Descobertas S.A.
Department Name: Dermatology
Principal Investigator Name: Pedro Mendes Bastos
Principal Investigator Email: pedro.mm.bastos@cuf.pt
Contact Person Name: Pedro Mendes Bastos
Contact Person Email: pedro.mm.bastos@cuf.pt

Site Name: Unidade Local De Saude De Coimbra E.P.E.
Department Name: Dermatology
Principal Investigator Name: Margarida Gonçalo
Principal Investigator Email: mmgoncalo@gmail.com
Contact Person Name: Margarida Gonçalo
Contact Person Email: mmgoncalo@gmail.com

Site Name: Unidade Local De Saude De Santo Antonio E.P.E.
Department Name: Dermatology
Principal Investigator Name: Tiago Torres
Principal Investigator Email: tiagotorres.dermatologia@chporto.min-saude.pt
Contact Person Name: Tiago Torres
Contact Person Email: tiagotorres.dermatologia@chporto.min-saude.pt

Sweden

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 20-03-2024
Processing Time Days: 22
Number Of Sites: 1
Number Of Participants: 5

Sites

Site Name: Karolinska University Hospital
Department Name: Not Applicable
Principal Investigator Name: Karin Popovic Silwerfeldt
Principal Investigator Email: Karin.popovic-silwerfeldt@regionstockholm.se
Contact Person Name: Karin Popovic Silwerfeldt
Contact Person Email: Karin.popovic-silwerfeldt@regionstockholm.se

Slovakia

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 19-03-2024
Processing Time Days: 21
Number Of Sites: 2
Number Of Participants: 8

Sites

Site Name: Artromac N.O.
Department Name: Reumatologicka ambulancia
Principal Investigator Name: Zelmira Macejova
Principal Investigator Email: macejova@hotmail.com
Contact Person Name: Zelmira Macejova
Contact Person Email: macejova@hotmail.com

Site Name: Narodny Ustav Reumatickych Chorob
Department Name: Reumatologicka ambulancia
Principal Investigator Name: Olga Lukacova
Principal Investigator Email: olga.lukacova@nurch.sk
Contact Person Name: Olga Lukacova
Contact Person Email: olga.lukacova@nurch.sk

Spain

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 21-03-2024
Processing Time Days: 23
Number Of Sites: 11
Number Of Participants: 35

Sites

Site Name: Hospital Universitario Rio Hortega
Department Name: Internal medicine
Principal Investigator Name: Maria Julia Barbado Ajo
Principal Investigator Email: jbarbadoa@saludcastillayleon.es
Contact Person Name: Maria Julia Barbado Ajo
Contact Person Email: jbarbadoa@saludcastillayleon.es

Site Name: Hospital Universitario Puerta De Hierro De Majadahonda
Department Name: Dermatology
Principal Investigator Name: Rita Cabeza Martínez
Principal Investigator Email: ritacabeza@gmail.com
Contact Person Name: Rita Cabeza Martínez
Contact Person Email: ritacabeza@gmail.com

Site Name: Hospital Del Mar
Department Name: Dermatology
Principal Investigator Name: Ramon Maria Pujol Vallverdu
Principal Investigator Email: rpujol@psmar.cat
Contact Person Name: Ramon Maria Pujol Vallverdu
Contact Person Email: rpujol@psmar.cat

Site Name: Hospital General Universitario Reina Sofia
Department Name: Dermatology
Principal Investigator Name: Juan Alberto Ruano Ruiz
Principal Investigator Email: juanruanoruiz@mac.com
Contact Person Name: Juan Alberto Ruano Ruiz
Contact Person Email: juanruanoruiz@mac.com

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Dermatology
Principal Investigator Name: Enrique Jorquera Barquero
Principal Investigator Email: ejorque@hotmail.com
Contact Person Name: Enrique Jorquera Barquero
Contact Person Email: ejorque@hotmail.com

Site Name: Hospital Germans Trias I Pujol
Department Name: Dermatology
Principal Investigator Name: Isabel Bielsa Marsol
Principal Investigator Email: ibielsa.germanstrias@gencat.cat
Contact Person Name: Isabel Bielsa Marsol
Contact Person Email: ibielsa.germanstrias@gencat.cat

Site Name: Complexo Hospitalario Universitario A Coruna
Department Name: Rheumatology
Principal Investigator Name: Francisco Javier Blanco García
Principal Investigator Email: fblagar@sergas.es
Contact Person Name: Francisco Javier Blanco García
Contact Person Email: fblagar@sergas.es

Site Name: Hospital Universitari Vall D Hebron
Department Name: Raumatology
Principal Investigator Name: Josefina Cortes Hernandéz
Principal Investigator Email: finacortes@hotmail.com
Contact Person Name: Josefina Cortes Hernandéz
Contact Person Email: finacortes@hotmail.com

Site Name: Hospital Universitario Fundacion Alcorcon
Department Name: Dermatology
Principal Investigator Name: Jose Luis Lopez Estebaranz
Principal Investigator Email: dermatologia.ensayos.hufa@gmail.com
Contact Person Name: Jose Luis Lopez Estebaranz
Contact Person Email: dermatologia.ensayos.hufa@gmail.com

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Dermatology
Principal Investigator Name: Esther Roe Crespo
Principal Investigator Email: eroe@santpau.cat
Contact Person Name: Esther Roe Crespo
Contact Person Email: eroe@santpau.cat

Site Name: Hospital General Universitario De Castellon
Department Name: Rheumatology
Principal Investigator Name: Maria Arantzazu Conesa Mateos
Principal Investigator Email: arantxaconesa@hotmail.com
Contact Person Name: Maria Arantzazu Conesa Mateos
Contact Person Email: arantxaconesa@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 21-03-2024
Processing Time Days: 23
Number Of Sites: 8
Number Of Participants: 40

Sites

Site Name: Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name: UOC di Dermatologia Clinica
Principal Investigator Name: Paola Nappa
Principal Investigator Email: paonappa@unina.it
Contact Person Name: Paola Nappa
Contact Person Email: paonappa@unina.it

Site Name: Ospedale San Raffaele S.r.l.
Department Name: U.O. di Medicina Gen. Ind. Immunologico Clinica
Principal Investigator Name: Lorenzo Dagna
Principal Investigator Email: dagna.trials@hsr.it
Contact Person Name: Lorenzo Dagna
Contact Person Email: dagna.trials@hsr.it

Site Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name: Clinica Dermatologica
Principal Investigator Name: Clara De Simone
Principal Investigator Email: clara.desimone@unicatt.it
Contact Person Name: Clara De Simone
Contact Person Email: clara.desimone@unicatt.it

Site Name: IRCCS Ospedale Policlinico San Martino
Department Name: Clinica Dermatologica
Principal Investigator Name: Emanuele Claudio Cozzani
Principal Investigator Email: emanuele.cozzani@unige.it
Contact Person Name: Emanuele Claudio Cozzani
Contact Person Email: emanuele.cozzani@unige.it

Site Name: University Of Florence
Department Name: Dipartimento di Scienze Dermatologiche
Principal Investigator Name: Marzia Caproni
Principal Investigator Email: marzia.caproni@unifi.it
Contact Person Name: Marzia Caproni
Contact Person Email: marzia.caproni@unifi.it

Site Name: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name: U.O.C. Dermatologia
Principal Investigator Name: Angelo Valerio Marzano
Principal Investigator Email: angelo.marzano@unimi.it
Contact Person Name: Angelo Valerio Marzano
Contact Person Email: angelo.marzano@unimi.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name: Dipartimento di Medicina Specialistica
Principal Investigator Name: Michelangelo La Placa
Principal Investigator Email: michelangelo.laplaca@unibo.it
Contact Person Name: Michelangelo La Placa
Contact Person Email: michelangelo.laplaca@unibo.it

Site Name: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name: Medicina Interna
Principal Investigator Name: Vincenzo Maione
Principal Investigator Email: maionevincenzo@gmail.com
Contact Person Name: Vincenzo Maione
Contact Person Email: maionevincenzo@gmail.com

France

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 22-03-2024
Processing Time Days: 24
Number Of Sites: 10
Number Of Participants: 42

Sites

Site Name: Besancon University Hospital Center
Department Name: Dermatology
Principal Investigator Name: Julie CASTAGNA
Principal Investigator Email: jcastagna@chu-besancon.fr
Contact Person Name: Julie CASTAGNA
Contact Person Email: jcastagna@chu-besancon.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Dermatology
Principal Investigator Name: Jean-David BOUAZIZ
Principal Investigator Email: jean-david.bouaziz@aphp.fr
Contact Person Name: Jean-David BOUAZIZ
Contact Person Email: jean-david.bouaziz@aphp.fr

Site Name: Hopital Tenon
Department Name: Dermatology
Principal Investigator Name: François CHASSET
Principal Investigator Email: francois.chasset@aphp.fr
Contact Person Name: François CHASSET
Contact Person Email: francois.chasset@aphp.fr

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: Dermatology
Principal Investigator Name: Didier BESSIS
Principal Investigator Email: d-bessis@chu-montpellier.fr
Contact Person Name: Didier BESSIS
Contact Person Email: d-bessis@chu-montpellier.fr

Site Name: Assistance Publique Hopitaux De Marseille
Department Name: Dermatology
Principal Investigator Name: Marie-Aleth RICHARD
Principal Investigator Email: mariealeth.richard@ap-hm.fr
Contact Person Name: Marie-Aleth RICHARD
Contact Person Email: mariealeth.richard@ap-hm.fr

Site Name: Hospital Edouard Herriot
Department Name: Dermatology
Principal Investigator Name: Cécile LESORT
Principal Investigator Email: cecile.lesort@chu-lyon.fr
Contact Person Name: Cécile LESORT
Contact Person Email: cecile.lesort@chu-lyon.fr

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: Dermatology
Principal Investigator Name: Delphine STAUMONT-SALLE
Principal Investigator Email: delphine.salle@chru-lille.fr
Contact Person Name: Delphine STAUMONT-SALLE
Contact Person Email: delphine.salle@chru-lille.fr

Site Name: Centre Hospitalier Universitaire De Toulouse
Department Name: Dermatology
Principal Investigator Name: Cristina BULAI LIVIDEANU
Principal Investigator Email: livideanu.c@chu-toulouse.fr
Contact Person Name: Cristina BULAI LIVIDEANU
Contact Person Email: livideanu.c@chu-toulouse.fr

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: Dermatology
Principal Investigator Name: Diane KOTTLER
Principal Investigator Email: kottler.diane@gmail.com
Contact Person Name: Diane KOTTLER
Contact Person Email: kottler.diane@gmail.com

Site Name: Hopital Prive D Antony
Department Name: Dermatology
Principal Investigator Name: Pierre-André BECHEREL
Principal Investigator Email: pa.becherel@gsante.net
Contact Person Name: Pierre-André BECHEREL
Contact Person Email: pa.becherel@gsante.net

Germany

Earliest CTIS Part Ii Submission Date: 27-02-2024
Latest Decision Or Authorization Date: 20-03-2024
Processing Time Days: 22
Number Of Sites: 14
Number Of Participants: 42

Sites

Site Name: Universitaet Muenster
Department Name: Klinik für Dermatologie und Venerologie
Principal Investigator Name: Kerstin Steinbrink
Principal Investigator Email: kerstin.steinbrink@ukmuenster.de
Contact Person Name: Kerstin Steinbrink
Contact Person Email: kerstin.steinbrink@ukmuenster.de

Site Name: Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Department Name: Derma Studien
Principal Investigator Name: Andreas Kleinheinz
Principal Investigator Email: Andreas.kleinheinz@elbekliniken.de
Contact Person Name: Andreas Kleinheinz
Contact Person Email: Andreas.kleinheinz@elbekliniken.de

Site Name: Universitaetsklinikum Halle (Saale) AöR
Department Name: Universitätsklinik für Dermatologie und Venerologie
Principal Investigator Name: Johannes Wohlrab
Principal Investigator Email: johannes.wohlrab@medizin.uni-halle.de
Contact Person Name: Johannes Wohlrab
Contact Person Email: johannes.wohlrab@medizin.uni-halle.de

Site Name: Universitaetsklinikum Erlangen AöR
Department Name: Hautklinik Studienambulanz
Principal Investigator Name: Michael Sticherling
Principal Investigator Email: Michael.sticherling@uk-erlangen.de
Contact Person Name: Michael Sticherling
Contact Person Email: Michael.sticherling@uk-erlangen.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Klinik für Dermatologie, Allergologie, Venerologie
Principal Investigator Name: Margitta Worm
Principal Investigator Email: margitta.worm@charite.de
Contact Person Name: Margitta Worm
Contact Person Email: margitta.worm@charite.de

Site Name: Klinikum Oldenburg AöR
Department Name: Universitätsklinik für Dermatologie und Allergologie
Principal Investigator Name: Nikolaos Patsinakidis
Principal Investigator Email: Patsinakidis.Nikolaos@Klinikum-Oldenburg.de
Contact Person Name: Nikolaos Patsinakidis
Contact Person Email: Patsinakidis.Nikolaos@Klinikum-Oldenburg.de

Site Name: Universitaetsklinikum Wuerzburg AöR
Department Name: Department of Dermatology, Venereology and Allergology
Principal Investigator Name: Matthias Goebler
Principal Investigator Email: Goebler_M1@ukw.de
Contact Person Name: Matthias Goebler
Contact Person Email: Goebler_M1@ukw.de

Site Name: Universitaetsklinikum Duesseldorf AöR
Department Name: Study center (address specified)
Principal Investigator Name: Stephan Meller
Principal Investigator Email: Stephan.Meller@med.uni-duesseldorf.de
Contact Person Name: Stephan Meller
Contact Person Email: Stephan.Meller@med.uni-duesseldorf.de

Site Name: Universitaetsklinikum Carl Gustav Carus Dresden
Department Name: Studienabteilung
Principal Investigator Name: Susanne Abraham
Principal Investigator Email: susanne.abraham@ukdd.de
Contact Person Name: Susanne Abraham
Contact Person Email: susanne.abraham@ukdd.de

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Clinic and Policlinic for Dermatology
Principal Investigator Name: Matthias Hahn
Principal Investigator Email: matthias.hahn@med.uni-tuebingen.de
Contact Person Name: Matthias Hahn
Contact Person Email: matthias.hahn@med.uni-tuebingen.de

Site Name: Universitaetsklinikum Aachen AöR
Department Name: Studienzentrum d. Med. Fak. der RWTH Aachen CTC-A
Principal Investigator Name: Amir Yazdi
Principal Investigator Email: ayazdi@ukaachen.de
Contact Person Name: Amir Yazdi
Contact Person Email: ayazdi@ukaachen.de

Site Name: Universitaetsklinikum Regensburg AöR
Department Name: Clinic and Policlinic for Dermatology
Principal Investigator Name: Bernadett Kurz
Principal Investigator Email: bernadett.kurz@ukr.de
Contact Person Name: Bernadett Kurz
Contact Person Email: bernadett.kurz@ukr.de

Site Name: Thermalsole und Schwefelbad Bentheim GmbH
Department Name: Klinisches Studienzentrum
Principal Investigator Name: Athanasios Tsianakas
Principal Investigator Email: a.tsianakas@fk-bentheim.de
Contact Person Name: Athanasios Tsianakas
Contact Person Email: a.tsianakas@fk-bentheim.de

Site Name: Klinikum der Ludwig-Maximilians-Universität München
Department Name: Klinik und Poliklinik fuer Dermatologie und Allergologie
Principal Investigator Name: Felix Lauffer
Principal Investigator Email: felix.lauffer@med.uni-muenchen.de
Contact Person Name: Felix Lauffer
Contact Person Email: felix.lauffer@med.uni-muenchen.de

Sponsor

Primary sponsor

Full Name: Biogen Idec Research Limited
Organisation Type: Pharmaceutical company
Country Of Registered Address: United Kingdom

Contract research organisations

Name: IQVIA Limited
Responsibilities: Project & Vendor management, 24hr Emergency contact; multiple operational responsibilities (codes provided in sponsor duties).

Name: PPD Global Limited
Responsibilities: Study support and submissions (coded duty: 8).

Name: Q Squared Solutions Limited
Responsibilities: Laboratory and sample management related activities (coded duty: 4).

Name: Continuum Clinical LLC
Responsibilities: Recruitment support and other operational tasks (codes: 11 and recruitment value).

Name: WCG Clinical Inc.
Responsibilities: Rater training and distribution of safety reports to sites.

Third parties

{"country":"United States","full_name":"Crisalis LLC","duties_or_roles":"Rater Training","organisation_type":"Non-Pharmaceutical company"}
{"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Project & Vendor management, 24hr Emergency contact; responsibilities coded: 1,11,12,15,2,5,6","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient ID card, recruitment materials","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Medical Imaging/Photography","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Laboratory services (coded duty: 4)","organisation_type":"Non-Pharmaceutical company"}
{"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Logistics (coded duty: 4)","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Duties coded: 8 (services/support as listed)","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Clinical Outcomes Solutions Limited","duties_or_roles":"Optional questionnaires","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"National Medical Services Inc.","duties_or_roles":"Laboratory services (coded duty: 4)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United States","full_name":"Specialty Laboratories Inc.","duties_or_roles":"Laboratory services (coded duty: 4)","organisation_type":"Laboratory/Research/Testing facility"}
{"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment supply (as requested by the sites)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Electronic data capture / eCOA (coded duty: 3)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Laboratory services (coded duty: 4)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Adjudication of patient photos","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Signant Health Global LLC (second entry)","duties_or_roles":"eCOA, Scales Management, Rater Training","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Project responsibilities coded: 11; Recruitment (value provided)","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Rater Training, distribution of safety reports to sites","organisation_type":"Pharmaceutical company"}
{"country":"France","full_name":"Inato","duties_or_roles":"Identification of sites and escalation point during site ID, SSV, SIV and recruitment and maintenance","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Quest Diagnostics Nichols Institute","duties_or_roles":"Laboratory services (coded duty: 4)","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name: BIIB059
Active Substance: LITIFILIMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS
Route: SUBCUTANEOUS

Investigational Product Name: BIIB059 placebo is a sterile liquid for injection. The formulation composition of the placebo is identical to that of BIIB059 drug product minus the active ingredient.
Modality: Other

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