Clinical trial • Phase II/III • Immunology|Dermatology
BELIMUMAB for Systemic sclerosis-associated interstitial lung disease
Phase II/III trial of BELIMUMAB for Systemic sclerosis-associated interstitial lung disease.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Systemic sclerosis-associated interstitial lung disease
- Trial Stage
- Phase II/III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 01-11-2023
- First CTIS Authorization Date
- 04-03-2024
Trial design
Randomised, treatment arm 1: belimumab 200 mg sc via syringe safety device every 7 days (±3 days). treatment arm 2: placebo sc via syringe safety device every 7 days (±3 days).-controlled, adaptive Phase II/III trial in Greece, Denmark, Finland and others.
- Randomised
- Yes
- Comparator
- Treatment arm 1: belimumab 200 mg SC via syringe safety device every 7 days (±3 days). Treatment arm 2: placebo SC via syringe safety device every 7 days (±3 days).
- Adaptive
- True (Independent Data Monitoring Committee (IDMC) will conduct periodic reviews of unblinded data including a futility interim analysis; controlled early access to unblinded PK/PD for model development; emergency unblinding procedures specified.)
- Target Sample Size
- 177
- Trial Duration For Participant
- 364
Eligibility
Recruits 177 No vulnerable population selected. Participants must be capable of giving signed informed consent. A caregiver may administer study medication if the participant is unable to self-administer. Optional sub-study consents (e.g., genetic) are handled via separate ICFs..
- Pregnancy Exclusion
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a WONCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%.
- Vulnerable Population
- No vulnerable population selected. Participants must be capable of giving signed informed consent. A caregiver may administer study medication if the participant is unable to self-administer. Optional sub-study consents (e.g., genetic) are handled via separate ICFs.
Inclusion criteria
- {"criterion_text":"- 1.\t18 years of age or old1.\t18 years of age or older.\n- 2.\tDocumented diagnosis of SSc as defined by the ACR/EULAR 2013 SSc classification criteria.\n- 3.\tDiffuse cutaneous disease, defined as presence of thickened skin with mRSS >0 over at least one skin area proximal to elbows and/or knees in addition to distal areas.\n- 4.\tPresence of interstitial lung disease.\n- 5.\tEvidence for active or progressive disease\n- 6.\tParticipant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.\n- 7.\tParticipant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study.\n- 8.\tFemale participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: •\tIs a WONCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR •\tIs a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%.\n- 9.\tCapable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.er."}
Exclusion criteria
- {"criterion_text":"- 1.\tSystemic sclerosis-like illness.\n- 2.\tPulmonary arterial hypertension.\n- 3.\tSSc renal crisis within 6 months .\n- 4.\tHistory or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n- 5.\tObstructive pulmonary disease (pre-bronchodilator FEV1/FVC <0.7).\n- 6.\tSignificant allergies to human or murine proteins, humanized monoclonal antibodies, or contrast agents.\n- 7.\tClinically significant multiple or severe drug allergies.\n- 8.\tLymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n- 9.\tBreast cancer within the past 10 years.\n- 10.\tALT>2 x ULN.\n- 11.\tTotal bilirubin >1.5 x ULN (isolated total bilirubin >1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).\n- 12.\tCirrhosis or current unstable liver or biliary disease.\n- 13.\tQTc >450 msec or QTc >480 msec in participants with bundle branch block.\n- 14.\tMajor surgery (including joint surgery) within 3 months or planned during the duration of the study.\n- 15.\tAn active infection, or a history of serious infections\n- 16.\tSymptomatic herpes zoster within 3 months.\n- 17.\tConfirmed diagnosis of active TB or untreated latent TB infection.\n- 18.\tConfirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms.\n- 19.\tParticipants with PHQ-9 score ≥10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or have any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, pose a significant suicide risk.\n- 20.\tPrevious or planned major organ transplant.\n- 21.\tCytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months.\n- 22.\tLive vaccine(s) within 30 days or plans to receive such vaccines during the study.\n- 23.\tPositive HIV antibody test.\n- 24. Serologic evidence of Hepatitis B infection based on the results of testing for HBsAg, Anti-HBc and Anti-HBs as follows: •\tPatients positive for HBsAg are excluded. •\tPatients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require clarification of their status by testing for HBV DNA. o\tif HBV DNA is detectable, patients will be excluded from participation. o\tif HBV DNA is not detectable, patients will be eligible to enroll.\n- 25.\tPositive hepatitis C antibody .\n- 26.\tHistory of a primary immunodeficiency, or hypogammaglobulinaemia (IgG <400 mg/dL), or IgA deficiency (IgA <10 mg/dL).\n- 27.\tHave a Grade 3 or greater neutropenia, defined as absolute neutrophil count <1000/mm3 (<1.0x10e9/L) based on the CTCAE v5.0."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Absolute change from baseline in FVC (mL) at Week 52.","definition_or_measurement_approach":"Absolute change from baseline in forced vital capacity (FVC) measured in mL at Week 52; change from baseline measurement of FVC."}
Secondary endpoints
- {"endpoint_text":"- 1. Absolute change from baseline in mRSS at Week 52.\n- 2. Absolute change from baseline in FACIT-Fatigue score at Week 52.\n- 3. Time to SSc progression or death.","definition_or_measurement_approach":"1) Change from baseline in modified Rodnan skin score (mRSS) at Week 52. 2) Change from baseline in FACIT-Fatigue patient-reported score at Week 52. 3) Time-to-event endpoint measuring time to systemic sclerosis (SSc) progression or death."}
Recruitment
- Registry Or Advocacy Recruitment
- True (patient advocacy group mentioned: 'patient advocacy group' in K2_content for website or social medial patient advocacy group; no specific group name provided)
- Digital Remote Recruitment
- True (digital methods include Facebook and Instagram adverts, website/web text, online videos and eConsent/on-screen materials, study website layout and online recruitment materials).
- Planned Sample Size
- 177
- Recruitment Window Months
- 42
- Consent Approach
- Informed consent obtained via signed ICF from each participant capable of giving consent. ICFs available in multiple languages (English, French, German, Spanish, Italian, Greek, Dutch/BE variants as indicated by document translations). Optional separate consent forms for genetic and optional substudies are provided. eConsent and educational videos/onscreen text are available as part of the consent process.
Methods
- Facebook advertisement (Advertisement for Subject Recruitment_Facebook_No CCI PI)
- Instagram advertisement (Advertisement for Subject Recruitment_Instagram_No CCI PI)
- Website and web text (K2_Recruitment_Study Website; K2_content for website or social medial patient advocacy group; K2_Website_No CCI PI)
- Posters, trifold and brochures (K2_Poster; K2_Trifold; K2_Brochure website; K2_Multifold)
- Patient letters and referral letters (K2_Patient Letter; K2_Recruitment_Referral Letter)
- Flipcharts and welcome guides for site use (K2_Recruitment_Flipchart; K2_Flipchart; K2_Welcome Guide)
- Videos and on-screen eConsent/educational materials (K2_Recruitment_Video Understanding Clinical Trials; UYS Video; Understanding Informed Consent and eConsent 2D Animation)
- Recruitment arrangements and informed consent procedures documents for sites (Recruitment and Informed Consent Procedure; K1_Recruitment and Informed Consent Procedure)
Geography
- Total Number Of Sites
- 49
- Total Number Of Participants
- 123
Greece
- Earliest CTIS Part Ii Submission Date
- 20-11-2023
- Latest Decision Or Authorization Date
- 07-03-2024
- Processing Time Days
- 108
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- 424 Military General Training Hospital
- Department Name
- Rheumatology Department
- Principal Investigator Name
- Periklis Vounotrypidis
- Principal Investigator Email
- perivoun@email.com
- Contact Person Name
- Periklis Vounotrypidis
- Contact Person Email
- perivoun@email.com
- Site Name
- University General Hospital Attikon
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Dimitrios Boumpas
- Principal Investigator Email
- boumpasd@uoc.gr
- Contact Person Name
- Dimitrios Boumpas
- Contact Person Email
- boumpasd@uoc.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 4th Internal Medicine Clinic
- Principal Investigator Name
- Theodoros Dimitroulas
- Principal Investigator Email
- dimitroul@hotmail.com
- Contact Person Name
- Theodoros Dimitroulas
- Contact Person Email
- dimitroul@hotmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- Rheumatology and Clinical Immunology
- Principal Investigator Name
- Dimitrios Bogdanos
- Principal Investigator Email
- bogdanos@med.uth.gr
- Contact Person Name
- Dimitrios Bogdanos
- Contact Person Email
- bogdanos@med.uth.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Pulmonology Clinic
- Principal Investigator Name
- Katerina Antoniou
- Principal Investigator Email
- kantoniou@med.uoc.gr
- Contact Person Name
- Katerina Antoniou
- Contact Person Email
- kantoniou@med.uoc.gr
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-11-2023
- Latest Decision Or Authorization Date
- 04-03-2024
- Processing Time Days
- 105
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Region Midtjylland
- Department Name
- Reumatologisk Afdeling
- Principal Investigator Name
- Esben Naeser
- Principal Investigator Email
- auhhov@rm.dk
- Contact Person Name
- Esben Naeser
- Contact Person Email
- auhhov@rm.dk
Finland
- Earliest CTIS Part Ii Submission Date
- 05-02-2024
- Latest Decision Or Authorization Date
- 04-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Turku University Hospital
- Department Name
- Reumatologian ja kliinisen immunologian keskus
- Principal Investigator Name
- Laura Pirilä
- Principal Investigator Email
- etunimi.sukunimi@varha.fi
- Contact Person Name
- Laura Pirilä
- Contact Person Email
- etunimi.sukunimi@varha.fi
Belgium
- Earliest CTIS Part Ii Submission Date
- 06-02-2024
- Latest Decision Or Authorization Date
- 05-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Systeem Sclerose Unit
- Principal Investigator Name
- Vanessa Smith
- Principal Investigator Email
- vanessa.smith@ugent.be
- Contact Person Name
- Vanessa Smith
- Contact Person Email
- vanessa.smith@ugent.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Respiratory Medicine
- Principal Investigator Name
- Julien Guiot
- Principal Investigator Email
- j.guiot@chuliege.be
- Contact Person Name
- Julien Guiot
- Contact Person Email
- j.guiot@chuliege.be
Spain
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 04-03-2024
- Processing Time Days
- 76
- Number Of Sites
- 10
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Basurto
- Department Name
- Reumatologia
- Principal Investigator Name
- María Esther Ruiz Lucea
- Principal Investigator Email
- MARIAESTHER.RUIZLUCEA@osakidetza.eus
- Contact Person Name
- María Esther Ruiz Lucea
- Contact Person Email
- MARIAESTHER.RUIZLUCEA@osakidetza.eus
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medicina Interna
- Principal Investigator Name
- Salvador García Morillo
- Principal Investigator Email
- salvaymar@gmail.com
- Contact Person Name
- Salvador García Morillo
- Contact Person Email
- salvaymar@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Reumatologia
- Principal Investigator Name
- José Andrés Román Ivorra
- Principal Investigator Email
- roman_jan@gva.es
- Contact Person Name
- José Andrés Román Ivorra
- Contact Person Email
- roman_jan@gva.es
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Enfermedades Autoinmunes Sistémicas
- Principal Investigator Name
- José Luis Callejas Rubio
- Principal Investigator Email
- jlcalleja@telefonica.net
- Contact Person Name
- José Luis Callejas Rubio
- Contact Person Email
- jlcalleja@telefonica.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Reumatología
- Principal Investigator Name
- José Luis Tandaipan Jaime
- Principal Investigator Email
- jtandaipan@santpau.cat
- Contact Person Name
- José Luis Tandaipan Jaime
- Contact Person Email
- jtandaipan@santpau.cat
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Enfermedades Autoinmunes
- Principal Investigator Name
- Gerard Espinosa Garriga
- Principal Investigator Email
- GESPINO@clinic.cat
- Contact Person Name
- Gerard Espinosa Garriga
- Contact Person Email
- GESPINO@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medicina Interna
- Principal Investigator Name
- Alfredo Guillén del Castillo
- Principal Investigator Email
- alguillen@vhebron.net
- Contact Person Name
- Alfredo Guillén del Castillo
- Contact Person Email
- alguillen@vhebron.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Enfermedades Autoinmunes Sistémicas
- Principal Investigator Name
- Clara Itziar Soto Abánades
- Principal Investigator Email
- clarasoto27@gmail.com
- Contact Person Name
- Clara Itziar Soto Abánades
- Contact Person Email
- clarasoto27@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- Reumatologia
- Principal Investigator Name
- José María Pego Reigosa
- Principal Investigator Email
- jose.maria.pego.reigosa@sergas.es
- Contact Person Name
- José María Pego Reigosa
- Contact Person Email
- jose.maria.pego.reigosa@sergas.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Reumatologia
- Principal Investigator Name
- Julia Martínez Barrio
- Principal Investigator Email
- jmbarrio@salud.madrid.org
- Contact Person Name
- Julia Martínez Barrio
- Contact Person Email
- jmbarrio@salud.madrid.org
Germany
- Earliest CTIS Part Ii Submission Date
- 19-12-2023
- Latest Decision Or Authorization Date
- 07-03-2024
- Processing Time Days
- 79
- Number Of Sites
- 8
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Rheumatologie
- Principal Investigator Name
- Joerg Distler
- Principal Investigator Email
- joerg.distler@med.uni-duesseldorf.de
- Contact Person Name
- Joerg Distler
- Contact Person Email
- joerg.distler@med.uni-duesseldorf.de
- Site Name
- Muhlenkreiskliniken AöR
- Department Name
- Johannes Wesling Klinikum-Klinik für Rheumatologie und klinische Immunologie
- Principal Investigator Name
- Gunter Assmann
- Principal Investigator Email
- Gunter.Assmann@muehlenkreiskliniken.de
- Contact Person Name
- Gunter Assmann
- Contact Person Email
- Gunter.Assmann@muehlenkreiskliniken.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Dermatology
- 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
- Krankenhaus Porz Am Rhein gGmbH
- Department Name
- Rheumatology
- Principal Investigator Name
- Johannes Strunk
- Principal Investigator Email
- j.strunk@khporz.de
- Contact Person Name
- Johannes Strunk
- Contact Person Email
- j.strunk@khporz.de
- Site Name
- Klinikverbund St. Antonius und St. Josef GmbH
- Department Name
- Innere Medizin II - Internistische Rheumatologie
- Principal Investigator Name
- Annette Alberding
- Principal Investigator Email
- annette.alberding@cellitinnen.de
- Contact Person Name
- Annette Alberding
- Contact Person Email
- annette.alberding@cellitinnen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Internal Medicine |
- Principal Investigator Name
- Andreas Schwarting
- Principal Investigator Email
- schwarting@uni-mainz.de
- Contact Person Name
- Andreas Schwarting
- Contact Person Email
- schwarting@uni-mainz.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik II - Rheumatologie
- Principal Investigator Name
- Joerg Henes
- Principal Investigator Email
- joerg.henes@med.uni-tuebingen.de
- Contact Person Name
- Joerg Henes
- Contact Person Email
- joerg.henes@med.uni-tuebingen.de
- Site Name
- Klinikverbund St. Antonius und St. Josef GmbH (additional entry)
- Department Name
- see site record
- Principal Investigator Name
- Annette Alberding
- Principal Investigator Email
- annette.alberding@cellitinnen.de
- Contact Person Name
- Annette Alberding
- Contact Person Email
- annette.alberding@cellitinnen.de
France
- Earliest CTIS Part Ii Submission Date
- 20-11-2023
- Latest Decision Or Authorization Date
- 04-03-2024
- Processing Time Days
- 105
- Number Of Sites
- 7
- Number Of Participants
- 10
Sites
- Site Name
- Assistance Publique Hopitaux De Paris (Hôpital Cochin, service de Rhumatologie)
- Department Name
- Hôpital Cochin, service de Rhumatologie
- Principal Investigator Name
- Yannick Allanore
- Principal Investigator Email
- yannick.allanore@cch.aphp.fr
- Contact Person Name
- Yannick Allanore
- Contact Person Email
- yannick.allanore@cch.aphp.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Hôpital La Cavale Blanche, Service de Médecine Interne
- Principal Investigator Name
- Claire De Moreuil
- Principal Investigator Email
- claire.demoreuil@chu-brest.fr
- Contact Person Name
- Claire De Moreuil
- Contact Person Email
- claire.demoreuil@chu-brest.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Cochin, Service de Médecine Interne)
- Department Name
- Hôpital Cochin, Service de Médecine Interne
- Principal Investigator Name
- Benjamin Chaigne
- Principal Investigator Email
- benjamin.chaigne@aphp.fr
- Contact Person Name
- Benjamin Chaigne
- Contact Person Email
- benjamin.chaigne@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Hôpital pitié-salpétrière)
- Department Name
- Hôpital pitié-salpétrière, Service de Médecine maladies auto-immunes et systémiques
- Principal Investigator Name
- Zahir Amoura
- Principal Investigator Email
- zahir.amoura@aphp.fr
- Contact Person Name
- Zahir Amoura
- Contact Person Email
- zahir.amoura@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Hôpital Avicenne, service de pneumologie)
- Department Name
- Hôpital Avicenne, service de pneumologie
- Principal Investigator Name
- Yurdagul Uzunhan
- Principal Investigator Email
- yurdagul.uzunhan@aphp.fr
- Contact Person Name
- Yurdagul Uzunhan
- Contact Person Email
- yurdagul.uzunhan@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hôpital Rangueil, CHU Toulouse, service de médecine interne et immunologie clinique
- Principal Investigator Name
- Grégory Pugnet
- Principal Investigator Email
- pugnet.g@chu-toulouse.fr
- Contact Person Name
- Grégory Pugnet
- Contact Person Email
- pugnet.g@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris (other site entry)
- Department Name
- see site record
- Contact Person Name
- other contact
Italy
- Earliest CTIS Part Ii Submission Date
- 29-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 11
- Number Of Sites
- 15
- Number Of Participants
- 45
Sites
- Site Name
- University Hospital Of Ferrara
- Department Name
- UO Reumatologia
- Principal Investigator Name
- Marcello Govoni
- Principal Investigator Email
- gvl@unife.it
- Contact Person Name
- Marcello Govoni
- Contact Person Email
- gvl@unife.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- S.C. Reumatologia
- Principal Investigator Name
- Veronica Codullo
- Principal Investigator Email
- v.codullo@smatteo.pv.it
- Contact Person Name
- Veronica Codullo
- Contact Person Email
- v.codullo@smatteo.pv.it
- Site Name
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
- Department Name
- Day Hospital UOC Reumatologia
- Principal Investigator Name
- Nicoletta Del Papa
- Principal Investigator Email
- nicoletta.delpapa@asst-pini-cto.it
- Contact Person Name
- Nicoletta Del Papa
- Contact Person Email
- nicoletta.delpapa@asst-pini-cto.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Reumatologia
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Maria Antonietta D'Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D'Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Florenzo Iannone
- Principal Investigator Email
- florenzo.iannone@uniba.it
- Contact Person Name
- Florenzo Iannone
- Contact Person Email
- florenzo.iannone@uniba.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Elisabetta Zanatta
- Principal Investigator Email
- elisabetta.zanatta@unipd.it
- Contact Person Name
- Elisabetta Zanatta
- Contact Person Email
- elisabetta.zanatta@unipd.it
- Site Name
- Careggi University Hospital
- Department Name
- SODc di Reumatologia
- Principal Investigator Name
- Serena Guiducci
- Principal Investigator Email
- guiduccis@aou-careggi.toscana.it
- Contact Person Name
- Serena Guiducci
- Contact Person Email
- guiduccis@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Dipartimento Reumatologia
- Principal Investigator Name
- Renato Carignola
- Principal Investigator Email
- renatocarigno@gmail.com
- Contact Person Name
- Renato Carignola
- Contact Person Email
- renatocarigno@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Alberto Cauli
- Principal Investigator Email
- cauli@unica.it
- Contact Person Name
- Alberto Cauli
- Contact Person Email
- cauli@unica.it
- Site Name
- Azienda Ospedaliero Universitaria Integrata Verona
- Department Name
- Medicina Generale B
- Principal Investigator Name
- Elisa Tinazzi
- Principal Investigator Email
- elisa.tinazzi@univr.it
- Contact Person Name
- Elisa Tinazzi
- Contact Person Email
- elisa.tinazzi@univr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UO Reumatologia
- Principal Investigator Name
- Francesco Ciccia
- Principal Investigator Email
- f.ciccia.napoli@gmail.com
- Contact Person Name
- Francesco Ciccia
- Contact Person Email
- f.ciccia.napoli@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Dilia Giuggioli
- Principal Investigator Email
- dilia.giuggioli@unimore.it
- Contact Person Name
- Dilia Giuggioli
- Contact Person Email
- dilia.giuggioli@unimore.it
- Site Name
- Azienda Ospealiero Universitaria Policlinico Umberto I
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Simona Truglia
- Principal Investigator Email
- s.truglia@policlinicoumberto1.it
- Contact Person Name
- Simona Truglia
- Contact Person Email
- s.truglia@policlinicoumberto1.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Medica
- Principal Investigator Name
- Gianluca Moroncini
- Principal Investigator Email
- g.moroncini@staff.univpm.it
- Contact Person Name
- Gianluca Moroncini
- Contact Person Email
- g.moroncini@staff.univpm.it
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Sermes CRO
- Responsibilities
- patient fee reimbursement
Third parties
- {"country":"United States","full_name":"Medqia LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Courier for drug deliver to patient’s home","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment Support","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Srcl Consenur S.L.","duties_or_roles":"sharp destruction","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Trial Form Support S.L.","duties_or_roles":"Site Coordination Services, including data management","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"medicine product destruction","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"Study Participant Feedback Questionaire","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"Other (for some sites only) - HRCT + ECG + local lab assessments (if specifically required by protocol)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient fee reimbursement","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"Other (for some sites only) - HRCT + ECG + local lab assessments (if specifically required by protocol)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Italy","full_name":"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico","duties_or_roles":"study-specific assessment (pulmonary function tests) on behalf of Site “Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto” in Milan (Italy)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ZALARIS Deutschland GmbH","duties_or_roles":"Reimbursement of patient fees and compensation","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Participant travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Reimbursement of patient fees","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Study Participant Feedback Questionaire / long term storage for biological samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc. (additional entry)","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Biocair International Limited","duties_or_roles":"Malfunction syringe return kit","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Adjudication committee","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"long term storage for biological samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Azenta Germany GmbH (additional entry)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Spirometry","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Benlysta 200 mg solution for injection in pre-filled syringe.
- Active Substance
- BELIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation available (EU/1/11/700/006)
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg
- Frequency
- Every 7 days (±3 days)
- Maximum Dose
- 200 mg
- Investigational Product Name
- Placebo for Belimumab Solution for Injection, 200 mg/mL
- Modality
- Other
- Frequency
- Every 7 days (±3 days) (matching belimumab schedule)
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