Clinical trial • Phase III • Immunology | Respiratory | Rare Disease
BELIMUMAB for Systemic sclerosis-associated interstitial lung disease (SSc-ILD) | Connective tissue disease-associated interstitial lung disease (CTD-ILD)
Phase III trial of BELIMUMAB for Systemic sclerosis-associated interstitial lung disease (SSc-ILD) | Connective tissue disease-associated interstitial lun…
Overview
- Trial Therapeutic Area
- Immunology | Respiratory | Rare Disease
- Trial Disease
- Systemic sclerosis-associated interstitial lung disease (SSc-ILD) | Connective tissue disease-associated interstitial lung disease (CTD-ILD)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 09-09-2024
- First CTIS Authorization Date
- 16-01-2025
Trial design
open-label, none/not specified-controlled Phase III trial in Denmark, Germany, Finland and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 342
- Trial Duration For Participant
- 364
Eligibility
Recruits 342 Participants must be capable of giving signed informed consent; the protocol states participants must be capable of providing signed informed consent. No vulnerable populations (e.g., children) selected; assent or parental consent procedures are not described in the available submission materials..
- 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: INC#4 o Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Section 10.4: Contraceptive and Barrier Guidance. OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 (Appendix 4: Contraceptive and Barrier Guidance) during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. − A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. See Section 8.3.5. − If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. − Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. − The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Vulnerable Population
- Participants must be capable of giving signed informed consent; the protocol states participants must be capable of providing signed informed consent. No vulnerable populations (e.g., children) selected; assent or parental consent procedures are not described in the available submission materials.
Inclusion criteria
- {"criterion_text":"- Participants with SSc-ILD or other CTD-ILDs that have completed either study 218224 or 221672 through to and including the Week 52 visit and are not considered treatment failure, defined as meeting either of the following criteria: INC#1 o Initiation of new immunosuppressive or immunomodulatory medication for SSc or other CTD-related disease activity/progression since joining study 218224 or 221672. o Increase of systemic corticosteroids beyond the allowed limits, for SSc or other CTD-related disease activity/progression since joining study 218224 or 221672 o Discontinuation of study medication during study 218224 or 221672 for any reason."}
- {"criterion_text":"- Participants with SSc should have an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow subcutaneous (SC) injection at the abdomen or the front, middle region of the thigh."}
- {"criterion_text":"- Participant is capable and willing to self-administer the study medication or has a caregiver/healthcare professional who is capable and willing to administer the study medication throughout the study"}
- {"criterion_text":"- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: INC#4 o Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Section 10.4: Contraceptive and Barrier Guidance. OR o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 (Appendix 4: Contraceptive and Barrier Guidance) during the study treatment period and for at least 4 months after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. − A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before the first dose of study intervention. See Section 8.3.5. − If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. − Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5. − The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy."}
- {"criterion_text":"- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol."}
Exclusion criteria
- {"criterion_text":"- Participants of study 218224 or study 221672 who have discontinued study treatment, prior to Week 52"}
- {"criterion_text":"- Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk"}
- {"criterion_text":"- Participants who have developed any other medical diseases (e.g.., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that, in the opinion of the investigator could significantly alter the absorption, metabolism, or elimination of drugs; constitutes a risk when taking the study intervention; interferes with the interpretation of data; or it is not safe for the participant to continue on the study"}
- {"criterion_text":"- Participants who have been exposed to ionizing radiation in excess of 10 mSv above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies."}
- {"criterion_text":"- Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SSc or other CTD (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an AE in study 218224 or study 221672 that could, in the opinion of the principal investigator, put the participant at undue risk"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of AEs, AESIs and SAEs","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Absolute change from baseline* in FVC (mL) at OLE Weeks 12, 26 and 52.","definition_or_measurement_approach":"Absolute change from baseline in forced vital capacity (FVC) measured in mL at OLE Weeks 12, 26 and 52."}
Recruitment
- Planned Sample Size
- 342
- Recruitment Window Months
- 56
- Consent Approach
- Signed informed consent is required from participants (participants must be capable of giving signed informed consent). Subject information and informed consent form (ICF) documents are provided in multiple language versions (examples in the submission include English, French, Dutch, Greek, Spanish, Italian, German). No assent/parental consent for minors is described.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 158
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-12-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 353
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Region Midtjylland
- Department Name
- Reumatologisk Afdeling
- Contact Person Name
- Esben Naeser
- Contact Person Email
- auhhov@rm.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 378
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Muehlenkreiskliniken AöR
- Department Name
- Johannes Wesling Klinikum Klinik für Rheumatologie und klinische Immunologie
- Contact Person Name
- Gunter Assmann
- Contact Person Email
- Gunter.Assmann@muehlenkreiskliniken.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik für Rheumatologie
- Contact Person Name
- Joerg Distler
- Contact Person Email
- joerg.distler@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik II
- Contact Person Name
- Joerg Henes
- Contact Person Email
- joerg.henes@med.uni-tuebingen.de
Finland
- Earliest CTIS Part Ii Submission Date
- 03-12-2024
- Latest Decision Or Authorization Date
- 17-12-2025
- Processing Time Days
- 379
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Turku University Hospital
- Department Name
- Reumatologian ja kliinisen immunologian keskus
- Contact Person Name
- Laura Pirilä
- Contact Person Email
- etunimi.sukunimi@varha.fi
Greece
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 428
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 4th Internal Medicine Clinic
- Contact Person Name
- Theodoros Dimitroulas
- Contact Person Email
- dimitroul@hotmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- Rheumatology and Clinical Immunology
- Contact Person Name
- Dimitrios Bogdanos
- Contact Person Email
- bogdanos@med.uth.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Thoracic Medicine Department
- Contact Person Name
- Katerina Antoniou
- Contact Person Email
- kantoniou@med.uoc.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 4th Department of Internal Medicine
- Contact Person Name
- Dimitrios Boumpas
- Contact Person Email
- boumpasd@uoc.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 18-12-2024
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 392
- Number Of Sites
- 15
- Number Of Participants
- 52
Sites
- Site Name
- Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
- Department Name
- Day Hospital UOC Reumatologia
- Contact Person Name
- Nicoletta Del Papa
- Contact Person Email
- nicoletta.delpapa@asst-pini-cto.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- UO Reumatologia
- Contact Person Name
- Marcello Govoni
- Contact Person Email
- gvl@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Medica
- Contact Person Name
- Gianluca Moroncini
- Contact Person Email
- g.moroncini@staff.univpm.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. di Reumatologia
- Contact Person Name
- Maria Antonietta D'Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- S.C.D.U. di Medicina Interna
- Contact Person Name
- Renato Carignola
- Contact Person Email
- renatocarigno@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Unità Operativa di Reumatologia
- Contact Person Name
- Francesco Ciccia
- Contact Person Email
- francesco.ciccia@unicampania.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Modena
- Department Name
- UOC Reumatologia
- Contact Person Name
- Dilia Giuggioli
- Contact Person Email
- dilia.giuggioli@unimore.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- UOC Reumatologia
- Contact Person Name
- Valeria Riccieri
- Contact Person Email
- valeria.riccieri@uniroma1.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- UOC Reumatologia
- Contact Person Name
- Florenzo Iannone
- Contact Person Email
- florenzo.iannone@uniba.it
- Site Name
- Careggi University Hospital
- Department Name
- SODc di Reumatologia
- Contact Person Name
- Serena Guiducci
- Contact Person Email
- serena.guiducci@unifi.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- S.C. Reumatologia
- Contact Person Name
- Veronica Codullo
- Contact Person Email
- v.codullo@smatteo.pv.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- UOC Reumatologia
- Contact Person Name
- Alberto Cauli
- Contact Person Email
- cauli@unica.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- Reumatologia
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- Medicina Generale B
- Contact Person Name
- Elisa Tinazzi
- Contact Person Email
- elisa.tinazzi@univr.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Reumatologia
- Contact Person Name
- Luca Iaccarino
- Contact Person Email
- luca.iaccarino@unipd.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 364
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Respiratory Medicine
- Contact Person Name
- Julien Guiot
- Contact Person Email
- j.guiot@chuliege.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Systemic Sclerosis Unit
- Contact Person Name
- Vanessa Smith
- Contact Person Email
- vanessa.smith@ugent.be
France
- Earliest CTIS Part Ii Submission Date
- 01-11-2024
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 550
- Number Of Sites
- 5
- Number Of Participants
- 17
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Internal Medicine
- Contact Person Name
- Benjamin Chaigne
- Contact Person Email
- benjamin.chaigne@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital pitié-salpétrière, Service de Médecine maladies auto-immunes et systémiques
- Contact Person Name
- Zahir Amoura
- Contact Person Email
- zahir.amoura@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hôpital Rangueil, CHU Toulouse, service de médecine interne et immunologie clinique
- Contact Person Name
- Grégory Pugnet
- Contact Person Email
- pugnet.g@chu-toulouse.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital Avicenne, service de pneumologie
- Contact Person Name
- Yurdagul Uzunhan
- Contact Person Email
- yurdagul.uzunhan@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital Cochin, service de Rhumatologie
- Contact Person Name
- Yannick Allanore
- Contact Person Email
- yannick.allanore@cch.aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 590
- Number Of Sites
- 9
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Systemic Autoimmune Diseases Service
- Contact Person Name
- Clara Itziar Soto Abánades
- Contact Person Email
- clarasoto27@gmail.com
- Site Name
- Hospital Universitario Basurto
- Department Name
- Rheumatology service
- Contact Person Name
- María Esther Ruiz Lucea
- Contact Person Email
- mariaesther.ruizlucea@osakidetza.eus
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Rheumatology service
- Contact Person Name
- Jose Luis Tandaipan Jaime
- Contact Person Email
- jtandaipan@santpau.cat
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- Rheumatology service
- 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
- Rheumatology service
- Contact Person Name
- Julia Martínez Barrio
- Contact Person Email
- jmbarrio@salud.madrid.org
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Systemic Autoimmune Diseases Service
- Contact Person Name
- José Luis Callejas Rubio
- Contact Person Email
- jlcalleja@telefonica.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal Medicine Service
- Contact Person Name
- Alfredo Guillén del Castillo
- Contact Person Email
- alguillen@vhebron.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Rheumatology service
- Contact Person Name
- José Andrés Román Ivorra
- Contact Person Email
- roman_jan@gva.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Internal Medicine Service
- Contact Person Name
- Salvador García Morillo
- Contact Person Email
- salvaymar@gmail.com
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- sponsorDuties codes: [1,12,15]; includes startup contract negotiations and other operational roles (contact: ICONGreekAffiliateMailbox@iconplc.com)
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [1,12,13,5,6,8]; operational/management responsibilities (contact: CTISAuthorityCommunications-Pharma@iconplc.com)
Third parties
- {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]; contact email DDS@alliancepharmaco.com","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"IL-CSM Clinical Supplies Management GmbH","duties_or_roles":"sponsorDuties codes: [14]; contact email info@il-csm.de","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact email CHA-CSIM@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"sponsorDuties: code 15 - Study Participant feedback questionnaire; contact email info@corevitas.com","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties: code 15 - Medicine product destruction; contact email albert.fort@alcura-health.es","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: [1,12,15]; contact email ICONGreekAffiliateMailbox@iconplc.com; includes startup contract negotiations","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"sponsorDuties codes: [4]; contact email ampelokipoi@bioiatriki.gr","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Biocair International Limited","duties_or_roles":"sponsorDuties codes: [15] - return any malfunction devices from sites to GSK; contact email bruce.williams@biocair.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: [4]; contact email CTCRC@Q2LabSolutions.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact email legal@medable.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"sponsorDuties codes: [15 (Image management and analysis), 6]; contact email bferracane@voiantclinical.com","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Kifissia","duties_or_roles":"sponsorDuties codes: [4]; contact email kifisia@affidea.com","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"Biocair International Limited","duties_or_roles":"sponsorDuties codes: [15] - return any malfunction devices from sites to GSK; contact email bruce.williams@biocair.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Marken LLP","duties_or_roles":"sponsorDuties codes: [15] - delivering IP from site to patients home; contact email info@marken.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"sponsorDuties codes: [15] - organizing adjudication committee; contact email advarra_dmc_eac_projteam@advarra.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"sponsorDuties codes: [14]; contact email commercial-clinicalsupplies@creapharm.com","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico","duties_or_roles":"sponsorDuties codes: [15] - Study-specific assessment (pulmonary function tests) on behalf of Site “Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto”; contact email pneumologia@policlinico.mi.it","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [13]; contact email customercare@clario.com","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"sponsorDuties codes: [4]; contact email piraeus.lab@affidea.com","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"","full_name":"Other listed third parties (multiple)","duties_or_roles":"Additional third parties are listed in the submission with specific operational roles (logistics, lab services, imaging, clinical supplies, etc.) and contact details in the CTIS record.","organisation_type":"Various"}
Investigational products
- Investigational Product Name
- Benlysta 200 mg solution for injection in pre-filled pen.
- Active Substance
- BELIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (marketing authorisation EU/1/11/700/003)
- Maximum Dose
- 200 mg/day (maxDailyDoseAmount 200; doseUom mg/ml); maxTotalDoseAmount 52000 mg/ml
Related trials
Other published trials that may interest you.