Clinical trial • Phase III • Immunology
LITIFILIMAB for Systemic lupus erythematosus
Phase III trial of LITIFILIMAB for Systemic lupus erythematosus.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 09-04-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, placebo (biib059 placebo is a sterile liquid for injection; formulation composition identical to biib059 drug product minus the active ingredient). background nonbiologic lupus standard of care (soc) therapy at stable dose is permitted and part of participants' background treatment.-controlled Phase III trial in Romania, Belgium, Czechia and others.
- Randomised
- Yes
- Comparator
- Placebo (Biib059 placebo is a sterile liquid for injection; formulation composition identical to BIIB059 drug product minus the active ingredient). Background nonbiologic lupus standard of care (SOC) therapy at stable dose is permitted and part of participants' background treatment.
- Target Sample Size
- 437
- Trial Duration For Participant
- 364
Eligibility
Recruits 437 Vulnerable population selected. Informed consent is addressed via multiple Subject Information and Informed Consent Forms (ICFs) and related documents. Country- and context-specific ICFs are provided (multiple language and versioned ICFs are listed in the trial documents, including a specific 'Pregnant Partner' ICF), indicating specific consent materials for particular vulnerable scenarios..
- Vulnerable Population
- Vulnerable population selected. Informed consent is addressed via multiple Subject Information and Informed Consent Forms (ICFs) and related documents. Country- and context-specific ICFs are provided (multiple language and versioned ICFs are listed in the trial documents, including a specific 'Pregnant Partner' ICF), indicating specific consent materials for particular vulnerable scenarios.
Inclusion criteria
- {"criterion_text":"- Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician"}
- {"criterion_text":"- Participant has a modified Systemic Lupus Erythematosus Disease Activity Index200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated)."}
- {"criterion_text":"- Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 [C3] and/or complement component 4 [C4], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization."}
- {"criterion_text":"- Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization."}
- {"criterion_text":"- Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization: a. Antimalarials as stand-alone treatment b. Antimalarial treatment in combination with OCS and/or a single immunosuppressant c. Treatment with OCS and/or a single immunosuppressant"}
- {"criterion_text":"- Other protocol defined inclusion criteria may apply"}
Exclusion criteria
- {"criterion_text":"- History of or positive test result for human immunodeficiency virus (HIV)."}
- {"criterion_text":"- Use of oral prednisone (or equivalent) above 20 mg/day."}
- {"criterion_text":"- Other protocol defined Exclusion criteria may apply"}
- {"criterion_text":"- Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV ribonucleic acid [RNA])."}
- {"criterion_text":"- Current hepatitis B infection (defined as positive for HBsAg and/or positive for total anti- HBc). with positive reflex HBV DNA)."}
- {"criterion_text":"- History of severe herpes infection"}
- {"criterion_text":"- Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure."}
- {"criterion_text":"- Active severe lupus nephritis where, in the opinion of the investigator, protocol specified SOC is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio >2.0 or severe chronic kidney disease (estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2]) calculated using the abbreviated Modification of Diet in Renal Disease equation."}
- {"criterion_text":"- Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or druginduced lupus."}
- {"criterion_text":"- History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome."}
- {"criterion_text":"- Active neuropsychiatric SLE."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52","definition_or_measurement_approach":"Proportion of participants achieving SRI-4 at Week 52 (assessed at Week 52)."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Who Achieved an SRI-4 Response at Week 24","definition_or_measurement_approach":"Proportion achieving SRI-4 at Week 24."}
- {"endpoint_text":"- Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52","definition_or_measurement_approach":"Percentage achieving a 50% reduction in affected joints (Joint-50) at Week 52 in participants with ≥4 affected joints at baseline."}
- {"endpoint_text":"- Percentage of Participants with OCS ≥10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52","definition_or_measurement_approach":"Proportion with steroid dose reduction to ≤7.5 mg/day at Week 40 sustained through Week 52 without disease worsening."}
- {"endpoint_text":"- Percentage of Participants with a CLASI-A Score ≥10 at Baseline Who Achieved a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16","definition_or_measurement_approach":"Proportion achieving CLASI-50 at Week 16 among participants with baseline CLASI-A ≥10."}
- {"endpoint_text":"- Annualized Flare Rate Through Week 52","definition_or_measurement_approach":"Annualized rate of disease flares observed through Week 52."}
- {"endpoint_text":"- Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit","definition_or_measurement_approach":"Visit-by-visit change from baseline in PGA VAS score."}
- {"endpoint_text":"- Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit","definition_or_measurement_approach":"Proportion achieving BICLA response at visits."}
- {"endpoint_text":"- Time to Onset of SRI-4 Response Sustained Through Week 52","definition_or_measurement_approach":"Time-to-event analysis for first SRI-4 response maintained through Week 52."}
- {"endpoint_text":"- Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit","definition_or_measurement_approach":"Visit-by-visit proportions achieving SRI-4/5/6."}
- {"endpoint_text":"- Percentage of Participants with Joint-50 Response by Visit","definition_or_measurement_approach":"Visit-by-visit proportion achieving Joint-50."}
- {"endpoint_text":"- Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit","definition_or_measurement_approach":"Visit-by-visit proportions achieving CLASI thresholds among those with baseline CLASI-A ≥10."}
- {"endpoint_text":"- Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit","definition_or_measurement_approach":"Visit-by-visit proportion achieving CLASI-A ≤1 among those with baseline CLASI-A ≥10."}
- {"endpoint_text":"- Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit","definition_or_measurement_approach":"Time-to-first BILAG-2004 defined severe flare."}
- {"endpoint_text":"- Time to First Severe Flare as Defined by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)","definition_or_measurement_approach":"Time-to-first severe flare per SFI definition."}
- {"endpoint_text":"- Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)","definition_or_measurement_approach":"Proportion of time participants are in LLDAS through assessments."}
- {"endpoint_text":"- Percentage of participants with sustained LLDAS as defined by the number of participants with ≥ 3, ≥ 5, and ≥ 7 consecutive visits in LLDAS up to and including week 52","definition_or_measurement_approach":"Proportion of participants with sustained consecutive visits in LLDAS (≥3, ≥5, ≥7) up to Week 52."}
- {"endpoint_text":"- Percentage of Participants who Achieved LLDAS at Week 52","definition_or_measurement_approach":"Proportion achieving LLDAS at Week 52."}
- {"endpoint_text":"- Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52","definition_or_measurement_approach":"Proportion of baseline high-dose steroid users reduced to ≤7.5 mg/day at Week 52."}
- {"endpoint_text":"- Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score","definition_or_measurement_approach":"Change from baseline in LupusQoL score."}
- {"endpoint_text":"- Change from Baseline in Short Form Health Survey-36 (SF-36) Score","definition_or_measurement_approach":"Change from baseline in SF-36 score."}
- {"endpoint_text":"- Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue score."}
- {"endpoint_text":"- Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score","definition_or_measurement_approach":"Change from baseline in PHQ-9 score."}
- {"endpoint_text":"- Change from Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score","definition_or_measurement_approach":"Change from baseline in WPAI:Lupus score."}
- {"endpoint_text":"- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","definition_or_measurement_approach":"Counts of participants experiencing TEAEs and SAEs during study."}
- {"endpoint_text":"- Number of Participants with Antibodies to BIIB059","definition_or_measurement_approach":"Number of participants who develop anti-BIIB059 antibodies."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 437
- Recruitment Window Months
- 66
- Consent Approach
- Informed consent is obtained using Subject Information and Informed Consent Forms (ICFs) and related materials. Multiple country- and language-specific ICFs and related documents are provided (e.g. EN, IT, NL, FR, DE, HU, CZ, RO versions listed). There are versioned/main ICFs and supplementary ICFs (including a 'Pregnant Partner' ICF and optional imaging consents); adults provide consent via the ICFs. No explicit assent process for minors is provided in the available documents.
Methods
- Use of digital recruitment materials: website landing pages and online prescreeners (e.g. 'Landing Page', 'Online Prescreener')
- Paid digital/online advertising including paid search ads and social media (Facebook ad copy, social media packet, GEM Programs paid search ads)
- Phone/digital self-screener ('Phone_Digital Self Screener')
- Physician-mediated recruitment: doctor-to-patient letters, physician referral letters, HCP brochures and study kits for clinicians
- Printed materials and in-clinic recruitment: patient flyers, posters, patient brochures, patient posters
- Referral and outreach materials: referral fact cards, study brochures, HCP referral letters
- Localised and country-specific recruitment materials and translations (multiple country versions of recruitment materials and ICFs exist)
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 437
Romania
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 705
- Number Of Sites
- 9
- Number Of Participants
- 33
Sites
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Liliana Duca
- Principal Investigator Email
- office@neomed.org
- Contact Person Name
- Liliana Duca
- Contact Person Email
- office@neomed.org
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Bogdan Horia Chicos
- Principal Investigator Email
- alis.mihai@reginamaria.ro
- Contact Person Name
- Bogdan Horia Chicos
- Contact Person Email
- alis.mihai@reginamaria.ro
- Site Name
- Policlinica CCBR S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Sorica Mustatea
- Principal Investigator Email
- clinicaltrials@clinicaccbr.com
- Contact Person Name
- Sorica Mustatea
- Contact Person Email
- clinicaltrials@clinicaccbr.com
- Site Name
- Selfmed Clinique S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Viorica Crisan
- Principal Investigator Email
- clinicaltrials@clinicaccbr.com
- Contact Person Name
- Viorica Crisan
- Contact Person Email
- clinicaltrials@clinicaccbr.com
- Site Name
- Hiperdia S.A.
- Department Name
- Rheumatology
- Principal Investigator Name
- Georgeta Camelia Badea
- Principal Investigator Email
- clinicaltrials@clinicaccbr.com
- Contact Person Name
- Georgeta Camelia Badea
- Contact Person Email
- clinicaltrials@clinicaccbr.com
- Site Name
- Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
- Department Name
- Rheumatology
- Principal Investigator Name
- Iulia-Codruta Bran (Belibou)
- Principal Investigator Email
- codrutabeli@yahoo.com
- Contact Person Name
- Iulia-Codruta Bran (Belibou)
- Contact Person Email
- codrutabeli@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Rheumatology
- Principal Investigator Name
- Simona Rednic
- Principal Investigator Email
- srednic@umfcluj.ro
- Contact Person Name
- Simona Rednic
- Contact Person Email
- srednic@umfcluj.ro
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Camelia Maricica Nita
- Principal Investigator Email
- camelia.nita@yahoo.com
- Contact Person Name
- Camelia Maricica Nita
- Contact Person Email
- camelia.nita@yahoo.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Monica Chis
- Principal Investigator Email
- monicacopotoiu@gmail.com
- Contact Person Name
- Monica Chis
- Contact Person Email
- monicacopotoiu@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 691
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Rheumatology
- Principal Investigator Name
- Christian Von Frenckell
- Principal Investigator Email
- cvonfrenckell@chuliege.be
- Contact Person Name
- Christian Von Frenckell
- Contact Person Email
- cvonfrenckell@chuliege.be
- Site Name
- UZ Leuven
- Department Name
- Rheumatology
- Principal Investigator Name
- Ellen De Langhe
- Principal Investigator Email
- ellen.delanghe@uzleuven.be
- Contact Person Name
- Ellen De Langhe
- Contact Person Email
- ellen.delanghe@uzleuven.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 681
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Revmatologie s.r.o.
- Department Name
- Revmatologie
- Principal Investigator Name
- Leona Procházková
- Principal Investigator Email
- revmatologie.prochazkova@seznam.cz
- Contact Person Name
- Leona Procházková
- Contact Person Email
- revmatologie.prochazkova@seznam.cz
- Site Name
- University Hospital Olomouc
- Department Name
- III. interní klinika - nefrologická, revmatologická a endokrinologická
- Principal Investigator Name
- Pavel Horák
- Principal Investigator Email
- pavel.horak@fnol.cz
- Contact Person Name
- Pavel Horák
- Contact Person Email
- pavel.horak@fnol.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 692
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Gebäude 605, EG, Zi. 0.221
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Med. Klinik
- Principal Investigator Name
- Gert Gabriels
- Principal Investigator Email
- Gert.Gabriels@ukmuenster.de
- Contact Person Name
- Gert Gabriels
- Contact Person Email
- Gert.Gabriels@ukmuenster.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Rheumatologie und Immunologie
- Principal Investigator Name
- Torsten Witte
- Principal Investigator Email
- witte.torsten@mh-hannover.de
- Contact Person Name
- Torsten Witte
- Contact Person Email
- witte.torsten@mh-hannover.de
- Site Name
- Medicover GmbH
- Department Name
- Medicover München Ost MVZ
- Principal Investigator Name
- David Kofler
- Principal Investigator Email
- david.kofler@medicover.de
- Contact Person Name
- David Kofler
- Contact Person Email
- david.kofler@medicover.de
Italy
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 681
- Number Of Sites
- 7
- Number Of Participants
- 17
Sites
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Gian Domenico Sebastiani
- Principal Investigator Email
- sebastiani@scamilloforlanini.rm.it
- Contact Person Name
- Gian Domenico Sebastiani
- Contact Person Email
- sebastiani@scamilloforlanini.rm.it
- Site Name
- Azienda Sanitaria Locale Di Salerno
- Department Name
- Rheumatology
- Principal Investigator Name
- Salvatore Scarpato
- Principal Investigator Email
- poscafati.reumatologia@aslsalerno.it
- Contact Person Name
- Salvatore Scarpato
- Contact Person Email
- poscafati.reumatologia@aslsalerno.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Rheumatology
- Principal Investigator Name
- Franco Franceschini
- Principal Investigator Email
- franco.franceschini@unibs.it
- Contact Person Name
- Franco Franceschini
- Contact Person Email
- franco.franceschini@unibs.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- Rheumatology
- Principal Investigator Name
- Luca Iaccarino
- Principal Investigator Email
- luca.iaccarino@unipd.it
- Contact Person Name
- Luca Iaccarino
- Contact Person Email
- luca.iaccarino@unipd.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Rheumatology
- Principal Investigator Name
- Marta Mosca
- Principal Investigator Email
- marta.mosca@med.unipi.it
- Contact Person Name
- Marta Mosca
- Contact Person Email
- marta.mosca@med.unipi.it
- Site Name
- Fondazione Policlinico Universitario Campus Bio-Medico
- Department Name
- Immuno-rheumatology
- Principal Investigator Name
- Roberto Giacomelli
- Principal Investigator Email
- r.giacomelli@policlinicocampus.it
- Contact Person Name
- Roberto Giacomelli
- Contact Person Email
- r.giacomelli@policlinicocampus.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Rheumatology
- Principal Investigator Name
- Fabrizio Conti
- Principal Investigator Email
- fabrizio.conti@uniroma1.it
- Contact Person Name
- Fabrizio Conti
- Contact Person Email
- fabrizio.conti@uniroma1.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 684
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Vital Medical Center
- Department Name
- -
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- drescher@invitel.hu
- Contact Person Name
- Edit Drescher
- Contact Person Email
- drescher@invitel.hu
- Site Name
- Vita Verum Medical Bt.
- Department Name
- -
- Principal Investigator Name
- Tünde Varga
- Principal Investigator Email
- tunde.varga@pro-smo.com
- Contact Person Name
- Tünde Varga
- Contact Person Email
- tunde.varga@pro-smo.com
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Belgyogyaszat - Immunologia
- Principal Investigator Name
- János Kádár
- Principal Investigator Email
- drkadarj@t-online.hu
- Contact Person Name
- János Kádár
- Contact Person Email
- drkadarj@t-online.hu
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Infektologia es Hepatologia
- Principal Investigator Name
- Tibor Martyin
- Principal Investigator Email
- martyintibor24@gmail.com
- Contact Person Name
- Tibor Martyin
- Contact Person Email
- martyintibor24@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 10-01-2024
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 681
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Dept of Reumatology
- Principal Investigator Name
- Michel Tsang-A-Sjoe
- Principal Investigator Email
- m.tsang-a-sjoe@amsterdamumc.nl
- Contact Person Name
- Michel Tsang-A-Sjoe
- Contact Person Email
- m.tsang-a-sjoe@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Dept. Rhemumatology
- Principal Investigator Name
- Maarten Limper
- Principal Investigator Email
- m.limper-2@umcutrecht.nl
- Contact Person Name
- Maarten Limper
- Contact Person Email
- m.limper-2@umcutrecht.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Dept of Rheumatology and Clinical Immunology
- Principal Investigator Name
- Karina De Leeuw
- Principal Investigator Email
- k.de.leeuw@umcg.nl
- Contact Person Name
- Karina De Leeuw
- Contact Person Email
- k.de.leeuw@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Biogen Idec Research Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Signant Health Global LLC
- Responsibilities
- IVRS – treatment randomization; Rater Training, Scale Management, eCOA
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Pharmacovigilance services
- Name
- Drugdev Inc.
- Responsibilities
- Site Start-up Management, Project & Vendor management, Medical Monitoring & 24hr Emergency contact
- Name
- IQVIA Limited
- Responsibilities
- Multiple clinical trial support activities (data management, monitoring, other coded responsibilities)
- Name
- Continuum Clinical LLC
- Responsibilities
- Patient Retention and Recruitment
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IVRS – treatment randomization; Rater Training, Scale Management, eCOA","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 Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Site Start-up Management, Project & Vendor management, Medical Monitoring & 24hr Emergency contact","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Docs24 Limited","duties_or_roles":"Printing Vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photography / Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Crisalis LLC","duties_or_roles":"Lupus Specific Rater Training","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Pharmacovigilance services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic data capture / clinical data services (code 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Study equipment supply","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Patient Retention and Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple study support functions (codes include 1,12,2,5 in sponsor duties)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BIIB059
- Active Substance
- LITIFILIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- 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
- Combination Treatment
- Yes
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