Clinical trial • Phase III • Immunology|Rare Disease

Depemokimab for Eosinophilic granulomatosis with polyangiitis (EGPA)

Phase III trial of Depemokimab for Eosinophilic granulomatosis with polyangiitis (EGPA).

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Eosinophilic granulomatosis with polyangiitis (EGPA)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
16-05-2024
First CTIS Authorization Date
13-06-2024

Trial design

Randomised, mepolizumab 300 mg subcutaneous every 4 weeks (comparator arm); double-dummy placebo arms are used for blinding (placebo for depemokimab and placebo for mepolizumab are included).-controlled Phase III trial across 37 sites in Hungary, Belgium, Poland and others.

Randomised
Yes
Comparator
Mepolizumab 300 mg subcutaneous every 4 weeks (comparator arm); double-dummy placebo arms are used for blinding (placebo for depemokimab and placebo for mepolizumab are included).
Target Sample Size
80
Trial Duration For Participant
364

Eligibility

Recruits 80 Vulnerable population flag selected. Only adults (≥18 years) may be enrolled. Participants must be capable of giving signed informed consent (see Section 10.1). French participants have a specific eligibility requirement: they must be affiliated to or a beneficiary of a social security category. Optional consents (e.g., genetic/biomarker) are described separately in the ICFs..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Vulnerable population flag selected. Only adults (≥18 years) may be enrolled. Participants must be capable of giving signed informed consent (see Section 10.1). French participants have a specific eligibility requirement: they must be affiliated to or a beneficiary of a social security category. Optional consents (e.g., genetic/biomarker) are described separately in the ICFs.

Inclusion criteria

  • {"criterion_text":"- Participant (male or female) must be 18 years or older at the time of signing the informed consent.\n- Participants who are ≥ 40 kg at Screening Visit 1.\n- Participants with a documented diagnosis of EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia defined in this study as >1.0x109/L and/or >10% of leucocytes plus at least 2 of the following additional features of EGPA: • a biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation • neuropathy, mono or poly (motor deficit or nerve conduction abnormality) • pulmonary infiltrates, non-fixed • sino-nasal abnormality • cardiomyopathy (established by echocardiography or magnetic resonance imaging [MRI]) • glomerulonephritis (haematuria, red cell casts, proteinuria) • alveolar haemorrhage (by bronchoalveolar lavage) • palpable purpura • ANCA positive Myeloperoxidase (MPO) or Proteinase 3 (PR3).\n- History of relapsing OR refractory disease defined as: • Relapsing disease: Participants must have a history of at least one confirmed EGPA relapse (i.e., requiring increase in oral corticosteroid (OCS) dose, initiation/increased dose of immunosuppressive therapy or inpatient hospitalisation due to EGPA) within the past 2 years. EGPA relapse should have occurred at least 12 weeks or more prior to Screening (Visit 1) whilst receiving a dose of prednisolone (or equivalent of) ≥7.5 mg/day. • China and Japan only definition of Relapsing disease: Participant must have a history of at least one confirmed EGPA relapse (i.e., requiring increase in OCS dose, initiation of IV prednisolone (or equivalent), initiation/increased dose of immunosuppressive therapy, initiation/increased dose of intravenous immunoglobulin (IVIG) or hospitalisation) within the past 2 years which occurred at least 12 weeks prior to Screening (Visit 1) whilst receiving a dose of prednisolone (or equivalent of) ≥7.5 mg/day. • Refractory disease: Defined as either: o Failure to attain remission (BVAS=0 and OCS dose ≤7.5 mg/day prednisolone or equivalent) within the last 6 months prior to Screening Visit 1 and following induction treatment with a standard OCS regimen, administered for at least 3 months OR o Participants with recurrence of EGPA symptoms within 6 months prior to Screening (Visit 1) whilst tapering OCS and occurring at any dose level ≥7.5 mg/day prednisolone or equivalent.\n- Corticosteroid therapy: Participants must be on a stable dose of oral prednisolone or prednisone of ≥7.5 mg/day (but not >50 mg/day) or equivalent for at least 4 weeks prior to Baseline (Visit 2).\n- Immunosuppressive therapy: If receiving immunosuppressive therapy (excluding cyclophosphamide) the dosage must be stable for the 4 weeks prior to Baseline (Visit 2) and during the study.\n- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) • Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, from at least 14 days prior to the first dose of study intervention until the following durations (whichever is greater): o 30 weeks after the last potential administration of depemokimab at Week 1 or Week 26, o 16 weeks after the last potential administration of mepolizumab (remaining administrations).\n- Capable of giving signed informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. French participants: In France, a participant will be eligible for inclusion in this study only if he/she is either affiliated to or a beneficiary of a social security category."}

Exclusion criteria

  • {"criterion_text":"- Diagnosed with granulomatosis with polyangiitis or MPA.\n- EULAR defined organ-threatening EGPA: Organ-threatening EGPA as per EULAR criteria, i.e., organ failure due to active vasculitis, creatinine >5.8 mg/dL (>513 μmol/L) within 3 months prior to Screening (Visit 1).\n- Imminently life-threatening EGPA disease defined as any of the following within 3 months prior to Screening (Visit 1): • Intensive care required • Severe alveolar haemorrhage or haemoptysis requiring transfusion or ventilation or haemoglobin <8 g/dL (<80 g/L) or drop in haemoglobin >2 g/dL (>20 g/L) over a 48-hour period due to alveolar haemorrhage • Rapidly progressive glomerulonephritis (RPGN) with creatinine >2.5 mg/dL (>221 μmol/L) or rise in creatinine >2 mg/dL (>177 μmol/L) over a 48-hour period • Severe GI involvement, e.g., gangrene, bleeding requiring surgery • Severe CNS involvement • Severe cardiac involvement\n- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. Participants that had localised carcinoma of the skin which was resected for cure will not be excluded.\n- Liver Disease: • Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) or if participant is on background methotrexate or azathioprine >3x ULN • AST >2x ULN or if participant is on background methotrexate or azathioprine >3x ULN • Alkaline Phosphatase ≥2.0x ULN • Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) • Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.\n- Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment including but not limited to: • Known ejection fraction of <20%, OR • Severe heart failure that meets New York Heart Association Class IV, OR • Hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III OR • Myocardial infarction or angina diagnosed less than 3 months prior to or at Screening Visit 1 OR • Uncontrolled life threatening arrythmia within 3 months prior to or at Screening Visit 1.\n- Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory or any other system abnormalities that are not associated with EGPA and are uncontrolled with standard treatment.\n- Evidence of clinically significant abnormality in the haematological, biochemical or urinalysis screen at Visit 1, as judged by the investigator.\n- Infectious disease: Chronic or ongoing active infectious disease requiring systemic treatment.\n- Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.\n- A known immunodeficiency (e.g. HIV), other than that explained by the use of OCS or other immunosuppressants taken as therapy for EGPA.\n- COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active COVID-19 infection. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant must remain symptom-free.\n- Hypersensitivity: Participants with a known allergy or intolerance to a monoclonal antibody or biologic therapy or any of the excipients of the investigational products listed in Section 6.1.\n- Monoclonal antibodies • Monoclonal antibodies targeting IL-5/5R: Participants who have a previous documented failure with anti-IL-5/5R therapy (e.g., mepolizumab, reslizumab benralizumab), based on investigator's discretion. • Participants who have received mAb who have not undergone the required washout periods, prior to Visit 1.\n- Investigational Medications/clinical study: • Participants who have received treatment with investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products). • Participants who are currently participating in any other interventional clinical study.\n- Participants receiving other prohibited medications.\n- Previous participation in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 6 months prior to Screening Visit 1.\n- ECG Assessment: QTcF ≥450 msec or QTcF ≥480 msec for participants with Bundle Branch Block in the 12-lead ECG central overread from Screening Visit 1.\n- Alcohol/Substance Abuse\n- Participants who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Remission (i.e., a Birmingham Vasculitis Activity Score (BVAS)=0 and a dose of oral corticosteroids (OCS) ≤4mg/day) at both Week 36 and Week 52.","definition_or_measurement_approach":"Remission defined as BVAS = 0 and oral corticosteroid dose ≤4 mg/day; assessed at Week 36 and Week 52."}

Secondary endpoints

  • {"endpoint_text":"- Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks.","definition_or_measurement_approach":"Cumulative number of weeks during the 52-week intervention period where BVAS=0 and OCS dose ≤4 mg/day; categorized into specified week ranges."}
  • {"endpoint_text":"- Total accrued duration of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS dose ≤4 mg /day over the 52-week intervention period.","definition_or_measurement_approach":"Cumulative number of weeks during the 52-week intervention period where BVAS=0 and OCS dose ≤4 mg/day."}
  • {"endpoint_text":"- Time to first EGPA relapse.","definition_or_measurement_approach":"Time from randomisation/baseline to occurrence of first EGPA relapse as defined in protocol."}
  • {"endpoint_text":"- Mean OCS dose during the last 4 weeks of the study treatment period (Weeks 49 to 52) categorised as 0, >0 to ≤4, >4 to ≤7.5 or >7.5 mg/day.","definition_or_measurement_approach":"Average oral corticosteroid dose over Weeks 49–52, categorized into specified dose ranges."}
  • {"endpoint_text":"- Remission (BVAS=0 and OCS ≤4mg/day) within the first 24 weeks with continued remission until Week 52.","definition_or_measurement_approach":"Achievement of BVAS=0 and OCS ≤4 mg/day within 24 weeks and maintenance of remission through Week 52."}
  • {"endpoint_text":"- Remission using the European League against Rheumatism (EULAR) definition; BVAS=0 and OCS ≤7.5 mg/day at both Week 36 and Week 52.","definition_or_measurement_approach":"Remission per EULAR definition: BVAS=0 and OCS ≤7.5 mg/day at Weeks 36 and 52."}
  • {"endpoint_text":"- Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS≤7.5 mg/day over the 52-week intervention period categorised as zero weeks; >0 to <12 weeks; 12 to <24 weeks; 24 to <36 weeks or ≥36 weeks.","definition_or_measurement_approach":"Cumulative weeks during the 52-week period where BVAS=0 and OCS ≤7.5 mg/day, categorized into specified ranges."}
  • {"endpoint_text":"- Total accrued duration of remission according to the EULAR definition of remission, i.e., the accrued number of weeks where BVAS=0 plus OCS ≤7.5 mg/day over the 52-week intervention period.","definition_or_measurement_approach":"Cumulative number of weeks during the 52-week intervention period where BVAS=0 and OCS ≤7.5 mg/day."}
  • {"endpoint_text":"- Remission (BVAS=0 and OCS ≤7.5 mg/day) within the first 24 weeks with continued remission until Week 52.","definition_or_measurement_approach":"Achievement of BVAS=0 and OCS ≤7.5 mg/day within 24 weeks and continued remission until Week 52."}

Recruitment

Registry Or Advocacy Recruitment
True, Patient Advocacy Groups (PAG)
Digital Remote Recruitment
True, includes patient website prescreener, website-based prescreening tools, e-newsletters, text reminders, email reminders and HealthVibe digital engagement materials (opt-in, reminder text/email, surveys) as documented in recruitment materials.
Planned Sample Size
80
Recruitment Window Months
47
Consent Approach
Informed consent must be signed by the participant (participants must be capable of giving signed informed consent). ICF and study information sheets are provided; country- and language-specific ICF/SIS documents are available (multiple language versions documented, e.g., BE/EN/FR/NL/DE/IT/PL/PT/HU/SV). Optional consents for genetic and biomarker testing are provided separately (optional ICF documents). French-specific eligibility/consent note: participants in France must be affiliated to or beneficiaries of a social security category.

Methods

  • Site-based recruitment via physicians and clinics (dr-to-patient letters, dr-to-dr letters, physician referrals).
  • Chart review and site chart-review checklists to identify eligible patients (country-specific chart review checklist documents).
  • Patient advocacy group (PAG) outreach: PAG enewsletters, PAG to patient letters, PAG FAQ brochures and study fact sheets targeted at patient organisations.
  • Patient-directed materials: patient brochures, participation cards, study visit guides, flipcharts, flowcharts, visit reminder cards.
  • Digital/remote prescreening via patient website prescreener and study website.
  • Electronic communications: e-newsletters and email reminders.
  • Mobile/text reminders and digital engagement (HealthVibe materials documented under recruitment materials for certain countries).

Geography

Total Number Of Sites
37
Total Number Of Participants
80

Hungary

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
27-01-2025
Processing Time Days
280
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Department Name
Rheumatology
Contact Person Name
Judit Majnik
Contact Person Email
majnik.judit@irgalmas.hu
Number Of Participants
1

Belgium

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
12-06-2025
Processing Time Days
416
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Hopital Erasme
Department Name
Internal Medicine
Contact Person Name
Florence Roufosse
Contact Person Email
froufoss@ulb.ac.be
Number Of Participants
1
Site Name
UZ Leuven
Department Name
Internal Medicine
Contact Person Name
Albrecht Betrains
Contact Person Email
albrecht.betrains@uzleuven.be
Number Of Participants
1

Poland

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
637
Number Of Sites
3
Number Of Participants
28

Sites

Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
III Klinika Chorob Pluc i Onkologii
Contact Person Name
Dariusz Gawryluk
Contact Person Email
dpgawryluk@gmail.com
Number Of Participants
28
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii
Contact Person Name
Marta Kołacińska-Flont
Number Of Participants
0
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Alergologii i Pneumologii
Contact Person Name
Iwona Damps - Konstańska
Number Of Participants
0

Sweden

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
631
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Rheumatology
Contact Person Name
Giovanni Cagnotto
Contact Person Email
giovanni.cagnotto@med.lu.se
Number Of Participants
2

Portugal

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
627
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Rheumatology
Contact Person Name
Nikita Khmelinskii
Contact Person Email
nkhmelinskii@gmail.com
Number Of Participants
0
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Clinical Immunology
Contact Person Name
Tomas Fonseca
Number Of Participants
3

Germany

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
631
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Johannes Wesling Klinikum Minden
Department Name
Klinik für Rheumatologie und Klinische Immunologie
Contact Person Name
Gunter Assmann
Number Of Participants
0
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Rheumatology and Clinical Immunology
Contact Person Name
Stephanie Finzel
Number Of Participants
3

Spain

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
631
Number Of Sites
9
Number Of Participants
10

Sites

Site Name
Hospital Universitario De Navarra
Department Name
Neumología
Contact Person Name
Francisco Javier Campano Lancharro
Contact Person Email
jfcampano@separ.es
Number Of Participants
0
Site Name
Hospital Germans Trias I Pujol
Department Name
Reumatología
Contact Person Name
Ivette Casafont Solé
Number Of Participants
0
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Neumologia
Contact Person Name
Concepción Morales García
Number Of Participants
0
Site Name
Hospital Clinic De Barcelona
Department Name
Medicina Interna
Contact Person Name
Georgina Espigol Frigolé
Contact Person Email
gespingol@clinic.cat
Number Of Participants
0
Site Name
Hospital Universitario La Paz
Department Name
Medicina Interna
Contact Person Name
Angel Robles Marhuenda
Contact Person Email
aroblesmarhuenda@gmail.com
Number Of Participants
0
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Enfermedades autoinmunes
Contact Person Name
Jose Luis Callejas Rubio
Contact Person Email
jlcalleja@telefonica.net
Number Of Participants
0
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Reumatología
Contact Person Name
Jose Andrés Román Ivorra
Contact Person Email
roman_jan@gva.es
Number Of Participants
0
Site Name
Hospital Universitari Vall D Hebron
Department Name
Departamento de urgen
Contact Person Name
Roser Solans Laque
Contact Person Email
rsolanslaq@gmail.com
Number Of Participants
0
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Medicina Interna
Contact Person Name
Adela Marín Ballve
Contact Person Email
admarin@salud.aragon.es
Number Of Participants
10

Netherlands

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
631
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Rheumatology and Clinical Immunology
Contact Person Name
Abraham Rutgers
Contact Person Email
a.rutger@umcg.nl
Number Of Participants
0
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Pulmonology
Contact Person Name
Emiel Marges
Contact Person Email
e.r.marges@lumc.nl
Number Of Participants
4

France

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
626
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Department of Internal Medicine, Department of Vascular Medicine, Internal Medicine and Pulmonology
Contact Person Name
Claire de MOREUIL
Contact Person Email
claire.demoreuil@chu-brest.fr
Number Of Participants
0
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Department of Onco-Hematology
Contact Person Name
Bruno VILLEMAGNE
Contact Person Email
bruno.villemagne@chd-vendee.fr
Number Of Participants
0
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Medecine Interne
Contact Person Name
Antoine NEEL
Contact Person Email
antoine.neel@chu-nantes.fr
Number Of Participants
0
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Internal medicine department
Contact Person Name
Xavier PUECHAL
Contact Person Email
xavier.puechal@aphp.fr
Number Of Participants
4

Austria

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
631
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Medical University Of Graz
Department Name
Clinic for Rheumatology and Clinical Immunology
Contact Person Name
Jens Thiel
Contact Person Email
jens.thiel@medunigraz.at
Number Of Participants
3

Italy

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
627
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O.C. di Allergologia e Immunoreumatologia
Contact Person Name
Roberto Giacomelli
Contact Person Email
r.giacomelli@unicampus.it
Number Of Participants
0
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Allergology and Clinical Immunology Unit
Contact Person Name
Jan Schroeder
Number Of Participants
0
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO Reumatologia
Contact Person Name
Marco Taglietti
Number Of Participants
0
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Immunology, Rheumatology, Allergology and Rare Diseases Unit
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.lorenzo@unisr.it
Number Of Participants
0
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
UO Clinica Medica
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Number Of Participants
0
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Reumatologia
Contact Person Name
Francesca Bobbio Pallavicini
Number Of Participants
0
Site Name
Careggi University Hospital
Department Name
SOD Medicina Interna Interdisciplinare
Contact Person Name
Elena Silvestri
Contact Person Email
elena.silvestri@unifi.it
Number Of Participants
0
Site Name
University Of Bari Aldo Moro
Department Name
U.O.C. Medicina Interna G. Baccelli
Contact Person Name
Angelo Vacca
Contact Person Email
angelo.vacca@uniba.it
Number Of Participants
0
Site Name
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Centro Malattie Rare e lmmunologiche UOC Medicina lnterna 1
Contact Person Name
Francesco Cinetto
Contact Person Email
francesco.cine@gmail.com
Number Of Participants
0
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
UO Reumatologia
Contact Person Name
Chiara Baldini
Contact Person Email
chiara.baldini74@gmail.com
Number Of Participants
20

Sponsor

Primary sponsor

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

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Study operations including ICF medical writing, vendor management, participant recruitment materials, import/export support and other operational duties as listed in sponsor duties.
Name
WCG Clinical Inc.
Responsibilities
Study questionnaire licensing and translations (operational support)

Third parties

  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Study questionnaire licensing and translations","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage of the samples: optional exploratory serum/urine/whole blood RNA biomarker samples","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"PK Samples, ADA & neutralising Ab (immunogenicity) samples (serum)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quest Diagnostics Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Specialty Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"Study questionnaire electronic licensing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Multiple operational duties including ICF medical writing, vendor management, PT recruitment materials, Import/Export Support and other study management tasks","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Acetaminophen Toxicity Diagnostics LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Optional Genetic DNA Samples (whole blood)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Flatiron Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primera Analytical Solutions Corp.","duties_or_roles":"IL-5","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"ECG analysis; eCoA/Cardiac Safety","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
DEPEMOKIMAB
Active Substance
Depemokimab
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Investigational (product PRD5046670)
Starting Dose
200 mg
Frequency
Every 26 weeks
Investigational Product Name
MEPOLIZUMAB
Active Substance
Mepolizumab
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorized product repackaged for trial use (SUB21650 / Nucala listed)
Starting Dose
300 mg
Frequency
Every 4 weeks
Combination Treatment
Yes

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