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
- 19-06-2024
- First CTIS Authorization Date
- 23-07-2024
Trial design
Randomised, placebo: "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." (no dose or schedule specified in the ctis record)-controlled Phase III trial in France, Sweden, Netherlands and others.
- Randomised
- Yes
- Comparator
- Placebo: "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." (no dose or schedule specified in the CTIS record)
- Target Sample Size
- 669
- Trial Duration For Participant
- 1092
Eligibility
Recruits 669 No vulnerable population selected (isVulnerablePopulationSelected: false). "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." Participants must be able to provide informed consent; consent materials and ICFs are provided in multiple country/language-specific versions (adult ICFs and pregnant-partner ICFs listed in submitted documents)..
- Pregnancy Exclusion
- Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment.
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). "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." Participants must be able to provide informed consent; consent materials and ICFs are provided in multiple country/language-specific versions (adult ICFs and pregnant-partner ICFs listed in submitted documents).
Inclusion criteria
- {"criterion_text":"- Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52\n- 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.\n- All women of childbearing potential must agree to practice highly effective contraception during the study and for 126 days (18 weeks) after their last dose of study treatment. In addition, participants should not donate eggs during the study and for at least 126 days (18 weeks) after their last dose of study treatment. Where applicable, if not previously confirmed in the parent Phase 3 study, postmenopausal status must be confirmed as follows: for women ≤ 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level ≥ 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause."}
Exclusion criteria
- {"criterion_text":"- Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)\n- Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-- week treatment period)\n- Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose as specified in Table 3 and Table 4, since the preceding scheduled study visit, and not previously discussed with the Sponsor).\n- Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.\n- Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.\n- Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment.\n- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered (participation in observational registries is allowed).\n- Inability to comply with study requirements.\n- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrolment.\n- Use of prohibited concurrent medication or therapy during the parent Phase 3 studies\n- Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of Treatment Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":"No further definition or measurement approach provided in the CTIS record."}
- {"endpoint_text":"- Number of Serious Adverse Events (SAEs)","definition_or_measurement_approach":"No further definition or measurement approach provided in the CTIS record."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants who achieved an SRI-4 response by visit\n- Proportion of participants with at least 4 joints (both swollen and tender) at baseline who achieved a Joint-50 response by visit\n- Proportion of participants with a CLASI-A score ≥ 10 at baseline who achieved a CLASI-50, CLASI-70, and CLASI-90 response by visit\n- Proportion of participants who achieved a BICLA response by visit 4\n- Annualized severe SFI Flare Rate where severe flare is defined using the SFI definition\n- Percentage of time spent in LLDAS 5\n- Proportion of participants with sustained LLDAS\n- Duration of sustained LLDAS as defined by the number of visits in LLDAS\n- Annual change from baseline value from the parent Phase 3 studies in SDI score\n- Cumulative exposure to OCS over time\n- Proportion of participants with OCS ≤ 7.5 mg by visit\n- Proportion of participants with OCS ≤ 5 mg by visit\n- Participant-reported outcome measures: LupusQoL, SF-36 (Acute Version), EQ-5D-3L, FACIT-Fatigue, PHQ-9, WPAI:Lupus, and PtGA\n- Change in standard laboratory parameters and ECG results\n- Incidence of antibodies to litifilimab","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 669
- Recruitment Window Months
- 80
- Consent Approach
- Informed consent must be provided by each participant: "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." Adult main ICFs and additional ICFs (e.g., pregnant partner consent, pregnancy follow-up) are provided; subject information and consent documents are available in multiple country/language-specific versions as submitted (examples include English, French, Greek, Polish, Spanish, Hungarian, Dutch, Swedish, Italian, Bulgarian, Romanian, Czech, German).
Geography
- Total Number Of Sites
- 48
- Total Number Of Participants
- 279
France
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Rheumatology
- Principal Investigator Name
- Jacques MOREL
- Principal Investigator Email
- j-morel@chu-montpellier.fr
- Contact Person Name
- Jacques MOREL
- Contact Person Email
- j-morel@chu-montpellier.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Christophe RICHEZ
- Principal Investigator Email
- christophe.richez@chu-bordeaux.fr
- Contact Person Name
- Christophe RICHEZ
- Contact Person Email
- christophe.richez@chu-bordeaux.fr
- Site Name
- CHU Gabriel-Montpied
- Department Name
- Internal medicine
- Principal Investigator Name
- Marc ANDRE
- Principal Investigator Email
- mandre@chu-clermontferrand.fr
- Contact Person Name
- Marc ANDRE
- Contact Person Email
- mandre@chu-clermontferrand.fr
Sweden
- Latest Decision Or Authorization Date
- 23-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Dag Leonard
- Principal Investigator Email
- dag.leonard@medsci.uu.se
- Contact Person Name
- Dag Leonard
- Contact Person Email
- dag.leonard@medsci.uu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Iva Gunnarsson
- Principal Investigator Email
- iva.gunnarsson@regionstockholm.se
- Contact Person Name
- Iva Gunnarsson
- Contact Person Email
- iva.gunnarsson@regionstockholm.se
Netherlands
- Latest Decision Or Authorization Date
- 23-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- 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
Germany
- Latest Decision Or Authorization Date
- 26-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Department I of Internal Medicine
- Principal Investigator Name
- Philipp Köhler
- Principal Investigator Email
- philipp.koehler@uk-koeln.de
- Contact Person Name
- Philipp Köhler
- Contact Person Email
- philipp.koehler@uk-koeln.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- I. Medizinische Klinik - Rheumatologie
- 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
Greece
- Latest Decision Or Authorization Date
- 22-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 13
Sites
- Site Name
- Athens Naval Hospital
- Department Name
- Rheumatology Clinic
- Principal Investigator Name
- Gkikas Katsifis
- Principal Investigator Email
- katsifisg@yahoo.gr
- Contact Person Name
- Gkikas Katsifis
- Contact Person Email
- katsifisg@yahoo.gr
Poland
- Latest Decision Or Authorization Date
- 04-08-2024
- Number Of Sites
- 10
- Number Of Participants
- 48
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
- Principal Investigator Name
- Iwona Dankiewicz-Fares
- Principal Investigator Email
- iwonafares@wp.pl
- Contact Person Name
- Iwona Dankiewicz-Fares
- Contact Person Email
- iwonafares@wp.pl
- Site Name
- Care Access Polska Sp. z o.o.
- Principal Investigator Name
- Dorota Knychas
- Principal Investigator Email
- careaccess.pl@careaccess.com
- Contact Person Name
- Dorota Knychas
- Contact Person Email
- careaccess.pl@careaccess.com
- Site Name
- Prywatna Praktyka Lekarska Prof Dr Hab Med Pawel Hrycaj
- Principal Investigator Name
- Paweł Hrycaj
- Principal Investigator Email
- pawel.hrycaj@gmail.com
- Contact Person Name
- Paweł Hrycaj
- Contact Person Email
- pawel.hrycaj@gmail.com
- Site Name
- Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
- Principal Investigator Name
- Izabela Domysławska
- Principal Investigator Email
- novareuma@gmail.com
- Contact Person Name
- Izabela Domysławska
- Contact Person Email
- novareuma@gmail.com
- Site Name
- NZOZ BIF-MED s.c. POZ
- Principal Investigator Name
- Hanna Mastalerz
- Principal Investigator Email
- hannamastalerz@wp.pl
- Contact Person Name
- Hanna Mastalerz
- Contact Person Email
- hannamastalerz@wp.pl
- Site Name
- Malopolskie Badania Kliniczne Sp. z o.o.
- Principal Investigator Name
- Bogdan Batko
- Principal Investigator Email
- bpbatko@gmail.com
- Contact Person Name
- Bogdan Batko
- Contact Person Email
- bpbatko@gmail.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Principal Investigator Name
- Katarzyna Romanowska-Próchnicka
- Principal Investigator Email
- marta.jeka@medicover.com
- Contact Person Name
- Katarzyna Romanowska-Próchnicka
- Contact Person Email
- marta.jeka@medicover.com
- Site Name
- Rivermed Sp. z o.o.
- Principal Investigator Name
- Lucyna Szymczak-Bartz
- Principal Investigator Email
- monika.jakubowska@rivermed.pl
- Contact Person Name
- Lucyna Szymczak-Bartz
- Contact Person Email
- monika.jakubowska@rivermed.pl
- Site Name
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
- Principal Investigator Name
- Agnieszka Bielewicz-Zielińska
- Principal Investigator Email
- a.bielewicz-zielinska@klinikabadawcza.pl
- Contact Person Name
- Agnieszka Bielewicz-Zielińska
- Contact Person Email
- a.bielewicz-zielinska@klinikabadawcza.pl
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Mariusz Korkosz
- Principal Investigator Email
- mcm.mariusz.korkosz@mp.pl
- Contact Person Name
- Mariusz Korkosz
- Contact Person Email
- mcm.mariusz.korkosz@mp.pl
Hungary
- Latest Decision Or Authorization Date
- 25-07-2024
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Bekes Varmegyei Koezponti Korhaz
- Department Name
- Infektológia és Hepatológia
- Principal Investigator Name
- Tibor Martyin
- Principal Investigator Email
- martyintibor@freemail.hu
- Contact Person Name
- Tibor Martyin
- Contact Person Email
- martyintibor@freemail.hu
- Site Name
- Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
- Department Name
- 95. ép. 16. sz. rendelő
- Principal Investigator Name
- Tünde Varga
- Principal Investigator Email
- vargatundedr1@gmail.com
- Contact Person Name
- Tünde Varga
- Contact Person Email
- vargatundedr1@gmail.com
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Belgyógyászat - Immunológia
- 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
- Vital Medical Center
- Department Name
- -
- Principal Investigator Name
- Edit Drescher
- Principal Investigator Email
- dr.dreschere@gmail.com
- Contact Person Name
- Edit Drescher
- Contact Person Email
- dr.dreschere@gmail.com
Spain
- Latest Decision Or Authorization Date
- 23-07-2024
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Rheumatology
- Principal Investigator Name
- Juan Miguel Sanchez Burson
- Principal Investigator Email
- juan.sanchezburson@quironsalud.es
- Contact Person Name
- Juan Miguel Sanchez Burson
- Contact Person Email
- juan.sanchezburson@quironsalud.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Rheumatology
- Principal Investigator Name
- Josefina Cortes Hernandez
- Principal Investigator Email
- finacortes@hotmail.com
- Contact Person Name
- Josefina Cortes Hernandez
- Contact Person Email
- finacortes@hotmail.com
- 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
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Rheumatology
- Principal Investigator Name
- Francisco Javier Toyos Saenz de Miera
- Principal Investigator Email
- fjtoyos@gmail.com
- Contact Person Name
- Francisco Javier Toyos Saenz de Miera
- Contact Person Email
- fjtoyos@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Rheumatology
- Principal Investigator Name
- Ricardo Blanco Alonso
- Principal Investigator Email
- ensayosreumavaldecilla@gmail.com
- Contact Person Name
- Ricardo Blanco Alonso
- Contact Person Email
- ensayosreumavaldecilla@gmail.com
Bulgaria
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 11
- Number Of Participants
- 70
Sites
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Principal Investigator Name
- Delina Ivanova
- Principal Investigator Email
- dr-delina@mail.bg
- Contact Person Name
- Delina Ivanova
- Contact Person Email
- dr-delina@mail.bg
- Site Name
- University Multiprofessional Hospital For Active Treatment Plovdiv AD
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Ivan Goranov
- Principal Investigator Email
- goranov_ivan@yahoo.com
- Contact Person Name
- Ivan Goranov
- Contact Person Email
- goranov_ivan@yahoo.com
- Site Name
- Medical Center Artmed Ltd.
- Principal Investigator Name
- Mariela Geneva-Popova
- Principal Investigator Email
- genevapopova@yahoo.com
- Contact Person Name
- Mariela Geneva-Popova
- Contact Person Email
- genevapopova@yahoo.com
- Site Name
- Military Medical Academy
- Department Name
- Clinic 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
- 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
- University Multiprofile Hospital For Active Treatment Pulmed Ltd.
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Lyubomir Sapundzhiev
- Principal Investigator Email
- sapoundjiev@abv.bg
- Contact Person Name
- Lyubomir Sapundzhiev
- Contact Person Email
- sapoundjiev@abv.bg
- Site Name
- Dkc Fokus-5 Lzip OOD
- Principal Investigator Name
- Rasho Rashkov
- Principal Investigator Email
- proff_rashkov@yahoo.com
- Contact Person Name
- Rasho Rashkov
- Contact Person Email
- proff_rashkov@yahoo.com
- Site Name
- Dkc Fokus-5 Lzip OOD
- Principal Investigator Name
- Rumen Stoilov
- Principal Investigator Email
- rmstoilov@abv.bg
- Contact Person Name
- Rumen Stoilov
- Contact Person Email
- rmstoilov@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of Rheumatology
- Principal Investigator Name
- Mariana Ivanova
- Principal Investigator Email
- mariana_ig@abv.bg
- Contact Person Name
- Mariana Ivanova
- Contact Person Email
- mariana_ig@abv.bg
- Site Name
- Medical Center Artmed Ltd.
- Principal Investigator Name
- Mariela Geneva-Popova
- Principal Investigator Email
- genevapopova@yahoo.com
- Contact Person Name
- Mariela Geneva-Popova
- Contact Person Email
- genevapopova@yahoo.com
- Site Name
- University Multiprofessional Hospital For Active Treatment Plovdiv AD
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Ivan Goranov
- Principal Investigator Email
- goranov_ivan@yahoo.com
- Contact Person Name
- Ivan Goranov
- Contact Person Email
- goranov_ivan@yahoo.com
Czechia
- Latest Decision Or Authorization Date
- 09-09-2024
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- 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
- 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
Belgium
- Latest Decision Or Authorization Date
- 26-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 4
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
Italy
- Latest Decision Or Authorization Date
- 12-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Gian Domenico Sebastiani
- Principal Investigator Email
- gsebastiani@scamilloforlanini.rm.it
- Contact Person Name
- Gian Domenico Sebastiani
- Contact Person Email
- gsebastiani@scamilloforlanini.rm.it
Romania
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Hiperdia S.A.
- Department Name
- Rheumatology
- Principal Investigator Name
- Camelia Maricica Badea
- Principal Investigator Email
- clinicaltrials@clinicaccbr.com
- Contact Person Name
- Camelia Maricica Badea
- Contact Person Email
- clinicaltrials@clinicaccbr.com
- Site Name
- Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Liliana Duca
- Principal Investigator Email
- dana.negri@neomed.org
- Contact Person Name
- Liliana Duca
- Contact Person Email
- dana.negri@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
- 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
- Spitalul Clinic Judetean De Urgenta Cluj
- Department Name
- Rheumatology
- Principal Investigator Name
- Simona Rednic
- Principal Investigator Email
- cipri_marinescu@yahoo.com
- Contact Person Name
- Simona Rednic
- Contact Person Email
- cipri_marinescu@yahoo.com
Sponsor
Primary sponsor
- Full Name
- Biogen Idec Research Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Continuum Clinical LLC
- Responsibilities
- Patient Retention and Recruitment
- Name
- PPD Global Limited
- Responsibilities
- Safety Reporting
- Name
- Crisalis LLC
- Responsibilities
- Rater Training
- Name
- Q Squared Solutions Limited
- Responsibilities
- Central Labratory
- Name
- IQVIA Limited
- Responsibilities
- Site start-up management, project & vendor management, medical monitoring
- Name
- IQVIA RDS Hellas Single Member S.A.
- Responsibilities
- Local/regional operational support (multiple roles listed)
- Name
- Signant Health Global LLC
- Responsibilities
- eCOA, IXRS
Third parties
- {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"Patient Retention and Recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Safety Reporting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Crisalis LLC","duties_or_roles":"Rater Training","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Labratory","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Site start-up management, project & vendor management, medical monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Functions including clinical operations, lab/sample management, safety and other support roles (codes: 1,12,5,8 shown in record)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA, IXRS","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BIIB059
- Active Substance
- LITIFILIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- 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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