Clinical trial • Phase IV • Immunology

Belimumab for Systemic lupus erythematosus

Phase IV trial of Belimumab for Systemic lupus erythematosus. open-label, none/not specified-controlled. 257 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
08-10-2024

Trial design

open-label, none/not specified-controlled Phase IV trial in France, Germany, Portugal and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
257
Trial Duration For Participant
1092

Eligibility

Recruits 257 The record indicates 'isVulnerablePopulationSelected': true. Participants must be capable of giving signed informed consent. Caregiver-specific ICF is provided (L1_ICF_Caregiver document present) and eConsent materials are available. The sponsor provides subject information and consent materials (including caregiver ICF and pregnancy-specific ICF) and eConsent tools; participants are required to provide signed informed consent themselves..

Pregnancy Exclusion
Male and/or female; a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: • Not a WOCBP OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%.
Vulnerable Population
The record indicates 'isVulnerablePopulationSelected': true. Participants must be capable of giving signed informed consent. Caregiver-specific ICF is provided (L1_ICF_Caregiver document present) and eConsent materials are available. The sponsor provides subject information and consent materials (including caregiver ICF and pregnancy-specific ICF) and eConsent tools; participants are required to provide signed informed consent themselves.

Inclusion criteria

  • {"criterion_text":"- ≥18 years of age at the time of signing the informed consent.\n- Documented diagnosis of SLE within 2 years of signing the informed consent according to the EULAR/ACR SLE classification criteria 2019.\n- Have unequivocally positive autoantibody test results defined as an ANA titer ≥1:80 and/or a positive anti-dsDNA serum antibody test from 2 independent time points as follows: • Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results OR • One positive historical test result and 1 positive test result during the screening period.\n- Eligibility Adjudication Committee confirmation of active SLE defined as: • Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score >4, OR • Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) ≤4 and prednisone or equivalent dose ≥10 mg/day.\n- SDI = 0 at Screening\n- Stable, initial SLE therapy which includes any of the following or combination of the following: • AMs started at least 12 weeks prior to Screening study visit and on a stable dose for a minimum of 4 weeks prior to Day 1. • Oral prednisone at a dose of ≤20 mg/day. If a participant is not on oral prednisone prior to the Screening study visit, oral prednisone at a dose of ≤20 mg/day may be introduced during Screening. No change in oral prednisone dose may occur during the last 2 weeks during Screening prior to Day 1. • Conventional IS treatment for least 12 weeks prior to Screening study visit, and at a stable dose for a minimum of 4 weeks prior to Day 1.\n- Male and/or female; a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: • Not a WOCBP OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%.\n- Capable of giving signed informed consent."}

Exclusion criteria

  • {"criterion_text":"- Lymphoma, 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- Participants with history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.\n- Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, GI, hepatic, renal, neurological, psychiatric, malignancy, or infectious diseases) and/or a planned surgical procedure, which, in the opinion of the PI, could confound the results of the clinical study or put the participant at undue risk.\n- Have an acute or chronic infection including requiring management as follows: • Currently on any suppressive therapy for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. • A serious infection requiring treatment with IV/IM antibiotics and/or hospitalization if the last dose of antibiotics or the hospital discharge date was within 60 days of the first day of dosing (Day 1). Prophylactic anti-infective treatment is allowed.\n- Confirmed active or untreated latent tubercolosis (TB).\n- Confirmed PML or unexplained new-onset or deteriorating neurologic signs and symptoms.\n- Have severe active CNS lupus (including seizures, psychosis, organic brain syndrome, CVA, cerebritis, or CNS vasculitis) requiring therapeutic intervention within 60 days of Screening.\n- Active Lupus Nephritis defined as active urinary sediment and/or proteinuria >500 mg/24 hours or equivalent using spot urine protein to creatinine ratio, requiring induction therapy not permitted by protocol.\n- Participants with PHQ-9 score ≥10 that in the opinion of a mental healthcare professional pose a serious suicide risk, or 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 judgement, poses a significant suicide risk. NOTE: For participants with a PHQ-9 score ≥10, at the Screening visit or at the day 1 visit before the first administration of the study drug, it is required that they be referred for an assessment by a mental healthcare professional (e.g., locally licensed psychiatrist, psychologist, or master’s level therapist) before the investigator makes a final decision regarding suitability for enrolment.\n- Known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with diagnostic or therapeutic monoclonal antibodies."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achieving LLDAS at Week 52.","definition_or_measurement_approach":"Achievement of Lupus Low Disease Activity State (LLDAS) assessed at Week 52 as defined by the study protocol (LLDAS at Week 52)."}

Secondary endpoints

  • {"endpoint_text":"- Achieving SRI4 at Week 52.","definition_or_measurement_approach":"SLE Responder Index 4 (SRI-4) assessed at Week 52 as defined in the protocol."}
  • {"endpoint_text":"- Achieving LLDAS for ≥25% of time from Day 1 to Week 52.","definition_or_measurement_approach":"Proportion of time from Day 1 to Week 52 during which participant meets LLDAS criteria; assessed over study visits through Week 52."}
  • {"endpoint_text":"- Achieving average oral prednisone equivalent dose ≤5 mg/day at Week 52.","definition_or_measurement_approach":"Average daily oral prednisone-equivalent dose calculated and assessed at Week 52."}
  • {"endpoint_text":"- Incidence of severe flare (modified SFI) as assessed at Week 52.","definition_or_measurement_approach":"Incidence of severe disease flares measured by modified SELENA-SLEDAI Flare Index (SFI) at Week 52."}
  • {"endpoint_text":"- Part B: Achieving DORIS remission at Week 104.","definition_or_measurement_approach":"Achievement of DORIS-defined remission assessed at Week 104 (Part B assessments as per protocol)."}
  • {"endpoint_text":"- Part B: Maintaining an SDI of 0 at Week 156.","definition_or_measurement_approach":"SDI (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index) score maintained at 0 assessed at Week 156."}
  • {"endpoint_text":"- Part B: Incidence of AEs, SAEs and AESI up to Week 104 and up to Week 156.","definition_or_measurement_approach":"Adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) incidence tracked up to Week 104 and Week 156 per safety reporting in protocol."}

Recruitment

Registry Or Advocacy Recruitment
Yes
Digital Remote Recruitment
True - digital/remote methods include eConsent (patient eConsent landing pages, screenshots, storyboards, security/privacy guides), patient portal content, pre-screening website content, digital waiting room ads, social media posts, digital banners, and ePR participant journey emails.
Planned Sample Size
257
Recruitment Window Months
54
Consent Approach
Participants must be capable of providing signed informed consent (inclusion criterion). Multilingual subject information and consent forms are provided (documents include ICFs and SIS in English, French, Spanish, Portuguese, Greek, Italian, German as per country materials). eConsent materials (landing pages, screenshots, glossary, storyboard, security/privacy guides) are available to support electronic consent. A caregiver ICF is available for caregiver involvement. There are pregnancy-specific ICFs for pregnant participants where relevant. Referral for mental health assessment is required for participants scoring PHQ-9 ≥10 before final enrolment decisions.

Methods

  • Patient-facing recruitment materials (participant flyer, patient brochure, patient brochure updates) - country-specific versions present (e.g., FRA, DEU, ESP, PRT, IT, GR).
  • HCP / Physician referral letters (country-specific templates present) to enable clinician referral to study sites.
  • Patient Advocacy Group engagement via 'Patient Advocacy Group Letter' templates (country-specific versions present).
  • Digital outreach: Social media posts and digital banners (country-specific versions; e.g., FRA, DEU, ESP) and digital waiting room advertisements.
  • Radio advertisements (Germany and Spain versions present).
  • Site-based materials: Site posters and site-facing study portal materials.
  • Patient portal and pre-screening website content to support online pre-screening and information.
  • ePR / Participant Journey Emails (electronic participant recruitment/engagement emails) and digital participant journey content.
  • eConsent and electronic patient-facing landing pages, screenshots, storyboards and security/privacy guides to support remote consent.
  • Patient information video storyboard and other multimedia patient information tools.

Geography

Total Number Of Sites
39
Total Number Of Participants
93

France

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
26-08-2025
Processing Time Days
393
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Internal Medicine
Contact Person Name
Martin KILLIAN
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Internal Medicine
Contact Person Name
Nicolas BELHOMME
Contact Person Email
nicolas.belhomme@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Internal Medicine and Clinical Immunology
Contact Person Name
Christian LAVIGNE
Contact Person Email
chlavigne@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Internal Medicine
Contact Person Name
Eric HACHULLA
Contact Person Email
eric.hachulla@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Internal Medicine and infectious diseases department
Contact Person Name
Estibaliz LAZARO
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Internal medicine
Contact Person Name
Grégory PUGNET
Contact Person Email
pugnet.g@chu-toulouse.fr

Germany

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
05-08-2025
Processing Time Days
320
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
St. Elisabeth Hospitalgesellschaft Niederrhein mbH
Department Name
Rheumatology
Contact Person Name
Stefan Vordenbäumen
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I Medizinische Klinik und Poliklinik; Rheumatologie und Klinische Immunologie
Contact Person Name
Andreas Schwarting
Contact Person Email
schwarting@uni-mainz.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Jens Humrich
Contact Person Email
jens.humrich@uksh.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Med.Klinik und Poliklinik, Nephrologie
Contact Person Name
Julia Weinmann-Menke
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumatologie
Contact Person Name
Ioana Andreica

Portugal

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
368
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Rheumatology
Contact Person Name
Maria José Santos
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Internal Medicine - Clinical Immunology Unit
Contact Person Name
António Marinho
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Rheumatology
Contact Person Name
Luís Inês
Contact Person Email
5077@ulscoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Internal Medicine
Contact Person Name
Vera Bernardino

Greece

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
22-08-2025
Processing Time Days
331
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
General Hospital Of Athens G Gennimatas
Department Name
Reumatology Clinic
Contact Person Name
Pinelopi Konstantopoulou
Contact Person Email
nellykon2001@yahoo.com
Site Name
University General Hospital Of Heraklion
Department Name
Rheumatology Immunology Clinic
Contact Person Name
George Bertsias
Contact Person Email
gbertsias@uoc.gr
Site Name
Laiko General Hospital Of Athens
Department Name
Α’ Propaedeutic and Internal Medicine Clinic & Rheumatology Unit
Contact Person Name
Petros Sfikakis
Contact Person Email
psfikakis@med.uoa.gr
Site Name
Hippokration Hospital
Department Name
D’ Internal Medicine Clinic of AUTh
Contact Person Name
Theodoros Dimitroulas
Contact Person Email
dimitroul@hotmail.com
Site Name
Asklepieion Voulas General Hospital
Department Name
Department of Reumatology
Contact Person Name
Antonia Elezoglou
Contact Person Email
taniaelezoglou@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
D’ Internal Medicine Clinic
Contact Person Name
Dimitrios Boumpas
Contact Person Email
dpathologiki@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
D’ Internal Medicine Clinic
Contact Person Name
Dimitrios Boumpas
Contact Person Email
dpathologiki@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
433
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Hospital Del Mar
Department Name
Rheumatology
Contact Person Name
Tarek Carlos Salman Monte
Contact Person Email
tareto4@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Rheumatology
Contact Person Name
Nuria Lozano Rivas
Contact Person Email
nurietin@hotmail.com
Site Name
Hospital Universitario Rio Hortega
Department Name
Internal Medicine
Contact Person Name
María Julia Barbado Ajo
Site Name
Hospital Universitario Virgen De Valme
Department Name
Rheumatology
Contact Person Name
Sergio Rodríguez Montero
Contact Person Email
sergio.mont@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Rheumatology
Contact Person Name
Alejandro Escudero Contreras
Contact Person Email
alexcudero@hotmail.com
Site Name
Hospital Marina Baixa De La Vila Joiosa
Department Name
Rheumatology
Contact Person Name
José Rosas Gómez de Salazar
Contact Person Email
j.rosas.gs@gmail.com
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Rheumatology
Contact Person Name
José María Pego Reigosa
Site Name
Hospital General Universitario De Castellon
Department Name
Rheumatology
Contact Person Name
María Arantzazu Conesa Mateos
Contact Person Email
arantxaconesa@hotmail.com

Italy

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
503
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Rheumatology
Contact Person Name
Angela Ceribelli
Contact Person Email
angela.ceribelli@humanitas.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Rheumatology
Contact Person Name
Micaela Fredi
Contact Person Email
fredi.micaela@gmail.com
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Rheumatology
Contact Person Name
Giulia Pazzola
Contact Person Email
giulia.pazzola@ausl.re.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
Rheumatology
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Rheumatology
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Rheumatology
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@unisr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Rheumatology
Contact Person Name
Maria Antonietta D'Agostino
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Rheumatology
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
Rheumatology
Contact Person Name
Marcello Govoni
Contact Person Email
gvl@unife.it

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
IQVIA Limited
Responsibilities
Operational sponsor support (multiple sponsor duties including eCOA, E-Data Capture), contact eu_clinical_trials_information@iqvia.com
Name
Medidata Solutions Inc.
Responsibilities
Technology platform support (sponsor duty code 6), contact info@medidata.com
Name
Q Squared Solutions LLC
Responsibilities
Laboratory/testing responsibilities (sponsor duty code 4), contact eu_clinical_trials_information@iqvia.com
Name
Drugdev Inc.
Responsibilities
Site-facing study portal (site portal responsibilities)
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
Local IQVIA operational support in Greece (sponsor duties codes 1,12,8)
Name
Cisys Inc.
Responsibilities
Software-as-a-service for adjudication and eligibility
Name
Quest Diagnostics Nichols Institute Inc.
Responsibilities
Laboratory/testing responsibilities

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1,11,12,15 (value for code 15: eCOA, E-Data Capture); contact eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 6; contact info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Sponsor duties codes: 4; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Sponsor duties code 15 (value: Site facing Study Portal); contact emea@ctp.solutions.iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sponsor duties codes: 4; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Sponsor duties code 15 (value: Site equipment supply); contact sales@quipment.fr","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"Sponsor duties codes: 1,12,8; contact helen.volonaki@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Biocair International Limited","duties_or_roles":"Sponsor duties code 15 (value: GSK vendor for Returning of Malfunction of syringe safety devices to GSK); contact dataprotection@biocair.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Sponsor duties code 15 (value: Software as service for adjudication and eligibility); contact info@cisys.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"Sponsor duties code 4; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Laboratory/Research/Testing facility"}

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
Route
SUBCUTANEOUS
Authorisation Status
Authorised (EU MA number EU/1/11/700/003)
Maximum Dose
200

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