Clinical trial • Phase II • Respiratory

HUMAN NORMAL IMMUNOGLOBULIN for Non-cystic fibrosis bronchiectasis

Phase II trial of HUMAN NORMAL IMMUNOGLOBULIN for Non-cystic fibrosis bronchiectasis.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Non-cystic fibrosis bronchiectasis
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
04-06-2025
First CTIS Authorization Date
26-09-2025

Trial design

Randomised, csl787 high dose (nebulized human normal immunoglobulin) - dose not specified; csl787 low dose (nebulized human normal immunoglobulin) - dose not specified; placebo, inhalation solution (placebo arm) - product name: placebo, inhalation solution-controlled Phase II trial across 76 sites in Belgium, France, Germany and others.

Randomised
Yes
Comparator
CSL787 High Dose (nebulized human normal immunoglobulin) - dose not specified; CSL787 Low Dose (nebulized human normal immunoglobulin) - dose not specified; Placebo, inhalation solution (placebo arm) - product name: Placebo, inhalation solution
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
233

Eligibility

Recruits 233 No vulnerable populations selected in the Part I population settings; trial enrols adults aged 18–85 only. Informed consent is obtained from participants; subject information and informed consent forms (including a separate Pregnant Partner ICF) are provided in multiple languages as uploaded in the trial documents..

Vulnerable Population
No vulnerable populations selected in the Part I population settings; trial enrols adults aged 18–85 only. Informed consent is obtained from participants; subject information and informed consent forms (including a separate Pregnant Partner ICF) are provided in multiple languages as uploaded in the trial documents.

Inclusion criteria

  • {"criterion_text":"- Adult between the ages of 18 to 85 years"}
  • {"criterion_text":"- Primary diagnosis of NCFB confirmed by chest computed tomography (CT) scan, where bronchiectasis has been documented by a radiologist. Diagnosis in the medical records based on historical scans is acceptable if the chest CT scan confirming the participant’s NCFB diagnosis was performed within 12 months before enrollment. Participants for whom no chest CT scan results are available within the previous 12 months will undergo a chest CT scan during the Screening Period"}
  • {"criterion_text":"- Exacerbation history within the previous 1 year defined as either 1 of the following: − >= 2 documented exacerbations requiring oral and / or intravenous (IV) antibiotic therapy to treat a pulmonary infection. OR − 1 documented exacerbation requiring oral and / or IV antibiotic therapy to treat a pulmonary infection and a St. George’s Respiratory Questionnaire (SGRQ) total score > 40 at Screening. Note: Other medications to treat NCFB such as: maintenance treatment with oral macrolides, or dipeptidyl peptidase-1 (DPP-1) inhibitors are allowed, provided >= 1 historical exacerbation occurred while on the medication for >= 3 months at a stable dose"}
  • {"criterion_text":"- Postbronchodilator percentage of the predicted normal forced expiratory volume in 1 second of expiration [FEV1% predicted] > 35% and forced expiratory volume in 1 second (FEV1) >= 1 liter (L) obtained in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) standards for spirometry during Screening and at Baseline."}

Exclusion criteria

  • {"criterion_text":"- History of bronchospasm in response to inhaled therapies including inhaled antibiotics"}
  • {"criterion_text":"- Primary diagnosis of other pulmonary disorders, including chronic obstructive pulmonary disease (COPD) asthma or, diffuse panbronchiolitis (DPB), as determined by the investigator."}
  • {"criterion_text":"- Pulmonary exacerbation requiring antibiotic therapy within the 6 weeks before Baseline."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- TTF (Time to first) Exacerbation","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Annualized Exacerbation Rate (AER) (Exacerbation Event Rate Per Participant-year of Follow-up)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants Achieving a Clinically Important Difference in the Quality of Life–Bronchiectasis (QoL-B) Respiratory Symptoms Scale","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of Participants Achieving a Clinically Important Difference in the QoL-B Respiratory Symptoms Scale","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change From Baseline in QoL-B Respiratory Symptoms Scale","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Change From Baseline in Total Colony-forming Unit (CFUs) for Pathogenic Bacteria isolated from Sputum","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of Participants with Treatment-emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of Participants with TEAEs and SAEs","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
233
Recruitment Window Months
26
Consent Approach
Informed consent is obtained from adult participants (aged 18–85). Subject information sheets and informed consent forms (Main Adult ICF) are provided and uploaded for multiple countries/languages. A separate Pregnant Partner ICF is available. Documents and patient-facing materials are available in multiple languages (including English, French, Dutch, Polish, Greek, Hungarian, German, Italian, Spanish, Danish as per uploaded files).

Methods

  • K1/K2 recruitment arrangements (site-based recruitment) — recruitment arrangements documents uploaded for multiple Member States
  • Social media (SoMe) advertisements targeted by participating hospitals/sites (documents titled 'SoMe advertisement' for Hvidovre Hospital, Aarhus Universitetshospital, Esbjerg Sygehus, Odense University Hospital, Sjællands Universitetshospital Roskilde, Vejle Sygehus) — Denmark-specific social media recruitment materials present
  • Health magazine advertisement (document 'K2_Recruitment material Health magazine advertisement')
  • Standard site outreach using hospital/clinic channels and general recruitment materials (multiple 'K1_Recruitment arrangements' documents for participating countries)

Geography

Total Number Of Sites
76
Total Number Of Participants
226

Belgium

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
30
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
CHU Saint Pierre
Department Name
Pumonology/ Sleep lab
Contact Person Name
Marie BRUYNEEL
Contact Person Email
marie.bruyneel@stpierre-bru.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pulmonology and Respiratory Oncology
Contact Person Name
Ulrike LIMPE
Contact Person Email
ulrike.himpe@azdelta.be
Site Name
UZ Leuven
Department Name
Pulmonology
Contact Person Name
Natalie LORENT
Contact Person Email
natalie.lorent@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Respiratory Medicine
Contact Person Name
Eva VAN BRAECKEL
Contact Person Email
eva.vanbraeckel@UGent.be
Site Name
Emmaues
Department Name
Pneumology
Contact Person Name
Muriel LINS
Contact Person Email
Muriel.Lins@Emmaus.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Pulmonology
Contact Person Name
Mathias LEYS
Contact Person Email
matihias.leys@azgroeninge.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Respiratory Medicine
Contact Person Name
Katrien EGER
Contact Person Email
katrien.eger@uza.be
Site Name
Algemeen Ziekenhuis Delta (additional listing)
Department Name
Pulmonology and Respiratory Oncology

France

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
32
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Médecine Respiratoire et du Sommeil
Contact Person Name
Frédéric GAGNADOUX
Contact Person Email
fgagnadoux@chu-angers.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Pneumologie
Contact Person Name
Pascal CHANEZ
Contact Person Email
pascal.chanez@univ-amu.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pneumologie
Contact Person Name
Pierre-Régis BURGEL
Contact Person Email
pierre-regis.burgel@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumologie-Allergologie
Contact Person Name
Marlène MURRIS-ESPIN
Contact Person Email
murris.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Maladies Respiratoires
Contact Person Name
Claire ANDREJAK
Contact Person Email
andrejak.claire@chu-amiens.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Pneumologie
Contact Person Name
Raphaël LE MAO
Contact Person Email
raphael.lemao@chu-brest.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pulmonology/Respiratory Medicine
Contact Person Name
Sylvain MARCHAND-ADAM
Contact Person Email
s.marchandadam@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Pneumologie
Contact Person Name
Julie MACEY
Contact Person Email
julie.macey@chu-bordeaux.fr

Germany

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
27
Number Of Sites
10
Number Of Participants
38

Sites

Site Name
Technische Universitaet Dresden
Department Name
Pneumologie
Principal Investigator Name
martin Kloditz
Principal Investigator Email
martin.kloditz@uniklinikum-dresden.de
Contact Person Name
martin Kloditz
Site Name
IKF Pneumologie GmbH & Co. KG (Mainz)
Department Name
Pneumologie
Principal Investigator Name
Stephanie Korn
Principal Investigator Email
korn@ikf-pneumologie.de
Contact Person Name
Stephanie Korn
Contact Person Email
korn@ikf-pneumologie.de
Site Name
Pneumological Study Center Munich West
Department Name
Pneumological Study Center
Principal Investigator Name
Rainald Fischer
Principal Investigator Email
rainald.fischer@gmail.com
Contact Person Name
Rainald Fischer
Contact Person Email
rainald.fischer@gmail.com
Site Name
Pneumologisches Studienzentrum MVZ die Lungenaerzte
Department Name
pneumology
Principal Investigator Name
Markus Becker
Principal Investigator Email
becker@die-lungenaerzte.de
Contact Person Name
Markus Becker
Contact Person Email
becker@die-lungenaerzte.de
Site Name
Velocity Clinical Research Germany GmbH (Ahrensburg)
Department Name
Pulmonary research
Principal Investigator Name
Henrik Watz
Principal Investigator Email
hwatz@velocityclinical.com
Contact Person Name
Henrik Watz
Contact Person Email
hwatz@velocityclinical.com
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Pneumologie und Thorakale Onkologie
Principal Investigator Name
Pontus Mertsch
Principal Investigator Email
pontus.mertsch@med.uni-muenchen.de
Contact Person Name
Pontus Mertsch
Site Name
IKF Pneumologie GmbH & Co. KG (Frankfurt)
Department Name
Pneumologie
Principal Investigator Name
Andreas Eich
Principal Investigator Email
eich@ikf-pneumologie.de
Contact Person Name
Andreas Eich
Contact Person Email
eich@ikf-pneumologie.de
Site Name
Goethe University Frankfurt
Department Name
Pneumology/Allergologie
Principal Investigator Name
Wolfgang Gleiber
Principal Investigator Email
wolfgang.gleiber@ukffm.de
Contact Person Name
Wolfgang Gleiber
Contact Person Email
wolfgang.gleiber@ukffm.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Infectious Diseases and Infection Control
Principal Investigator Name
Mathias PLetz
Principal Investigator Email
Mathias.pletz@med.uni-jena.de
Contact Person Name
Mathias PLetz
Contact Person Email
Mathias.pletz@med.uni-jena.de
Site Name
Velocity Clinical Research Germany GmbH (Luebeck)
Department Name
pulmonary research
Principal Investigator Name
Konstanze Landerholm
Principal Investigator Email
klanderholm@velocityclinical.com
Contact Person Name
Konstanze Landerholm

Greece

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
101
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonology
Principal Investigator Name
Katerina Manika
Principal Investigator Email
ktmn@yahoo.gr
Contact Person Name
Katerina Manika
Contact Person Email
ktmn@yahoo.gr
Site Name
Euromedica General Clinic Of Thessaloniki
Department Name
Pulmonary
Principal Investigator Name
Pavlos Zarogoulidis
Principal Investigator Email
pzarog@hotmail.com
Contact Person Name
Pavlos Zarogoulidis
Contact Person Email
pzarog@hotmail.com
Site Name
General University Hospital Of Larissa
Department Name
Respiratory Medicine
Principal Investigator Name
Konstantinos Gourgoulianis
Principal Investigator Email
kgourg@med.uth.gr
Contact Person Name
Konstantinos Gourgoulianis
Contact Person Email
kgourg@med.uth.gr
Site Name
General University Hospital Of Patras
Department Name
Internal/Respiratory Medicine
Principal Investigator Name
Argyrios Tzouvelekis
Principal Investigator Email
atzouvelekis@upatras.gr
Contact Person Name
Argyrios Tzouvelekis
Contact Person Email
atzouvelekis@upatras.gr
Site Name
Thermi Clinic S.A.
Department Name
Internal Medicine
Principal Investigator Name
Stavros Tryfon
Principal Investigator Email
stavrostryfon@yahoo.gr
Contact Person Name
Stavros Tryfon
Contact Person Email
stavrostryfon@yahoo.gr

Hungary

Earliest CTIS Part Ii Submission Date
01-08-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
59
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Orszagos Koranyi Pulmonologiai Intezet
Department Name
Pulmonologiai
Principal Investigator Name
Soter Szabolcs
Principal Investigator Email
sotersz@freemail.hu
Contact Person Name
Soter Szabolcs
Contact Person Email
sotersz@freemail.hu
Site Name
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet
Department Name
Pulmonologiai
Principal Investigator Name
Magdolna Éva Poczi
Principal Investigator Email
magdolnapoczi@gmail.com
Contact Person Name
Magdolna Éva Poczi
Contact Person Email
magdolnapoczi@gmail.com
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonologiai
Principal Investigator Name
Veronika Müller
Principal Investigator Email
muller.veronika@semmelweis.hu
Contact Person Name
Veronika Müller
Contact Person Email
muller.veronika@semmelweis.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Pulmonologiai
Principal Investigator Name
Ibolya Laczo
Principal Investigator Email
laczoibolya@gmail.com
Contact Person Name
Ibolya Laczo
Contact Person Email
laczoibolya@gmail.com
Site Name
Farkasgyepui Tudogyogyintezet
Department Name
Pulmonologiai
Principal Investigator Name
Zsolt Kiraly
Principal Investigator Email
dr.kiraly.zsolt@gmail.com
Contact Person Name
Zsolt Kiraly
Contact Person Email
dr.kiraly.zsolt@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Pulmonologiai
Principal Investigator Name
Csaba Mathe
Principal Investigator Email
mathe.csaba@uzsoki.hu
Contact Person Name
Csaba Mathe
Contact Person Email
mathe.csaba@uzsoki.hu

Italy

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
42
Number Of Sites
8
Number Of Participants
40

Sites

Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Pulmonology
Principal Investigator Name
Marco Confalonieri
Principal Investigator Email
marco.confalonieri@ausgi.sanita.fvg.it
Contact Person Name
Marco Confalonieri
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Pneumology
Principal Investigator Name
Fabiano Di Marco
Principal Investigator Email
fdimarco@asst-pg23.it
Contact Person Name
Fabiano Di Marco
Contact Person Email
fdimarco@asst-pg23.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Respiratory Medicine - Pneumology
Principal Investigator Name
Paola Faverio
Principal Investigator Email
paola.faverio@unimib.it
Contact Person Name
Paola Faverio
Contact Person Email
paola.faverio@unimib.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
M.A.R. Universitaria - Ospedale C. D'Avanzo
Principal Investigator Name
Donato Lacedonia
Principal Investigator Email
donato.lacedonia@unifg.it
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Section Respiratory Disease and Center in Rare Lung Disease
Principal Investigator Name
Stefania Cerri
Principal Investigator Email
stefania.cerri@unimore.it
Contact Person Name
Stefania Cerri
Contact Person Email
stefania.cerri@unimore.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
S.C. Pneumologia
Principal Investigator Name
Angelo Corsico
Principal Investigator Email
corsico@unipv.it
Contact Person Name
Angelo Corsico
Contact Person Email
corsico@unipv.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Area Medica - S.C. Pneumologia e Fibrosi cistica
Principal Investigator Name
Bruno Blasi
Principal Investigator Email
francesco.blasi@policlinico.mi.it
Contact Person Name
Bruno Blasi
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O. Pneumologia 1
Principal Investigator Name
Stefano Aliberti
Principal Investigator Email
stefano.aliberti@hunimed.eu
Contact Person Name
Stefano Aliberti
Contact Person Email
stefano.aliberti@hunimed.eu

Netherlands

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
18
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Noordwest Ziekenhuisgroep Stichting
Department Name
Pulmonary Medicine
Principal Investigator Name
Lotte Terpstra
Principal Investigator Email
l.c.terpstra@nwz.nl
Contact Person Name
Lotte Terpstra
Contact Person Email
l.c.terpstra@nwz.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Pulmonary Medicine
Principal Investigator Name
Dominic Snijders
Principal Investigator Email
dsnijders@spaarnegasthuis.nl
Contact Person Name
Dominic Snijders
Contact Person Email
dsnijders@spaarnegasthuis.nl
Site Name
Gelre Hospitals
Department Name
Pulmonary medicine
Principal Investigator Name
Martijn Goosens
Principal Investigator Email
m.goosens@gelre.nl
Contact Person Name
Martijn Goosens
Contact Person Email
m.goosens@gelre.nl
Site Name
VUMC Stichting
Department Name
Pulmonary Medicine
Principal Investigator Name
Josje Altenburg
Principal Investigator Email
j.altenburg@amsterdamumc.nl
Contact Person Name
Josje Altenburg
Contact Person Email
j.altenburg@amsterdamumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Medicine
Principal Investigator Name
LSJ Kamphuis
Principal Investigator Email
l.kamphuis@erasmusmc.nl
Contact Person Name
LSJ Kamphuis
Contact Person Email
l.kamphuis@erasmusmc.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Department of Lung Medicine
Principal Investigator Name
Pascal Wielders
Principal Investigator Email
pascal.wielders@catharinaziekenhuis.nl
Contact Person Name
Pascal Wielders
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Pulmonary Medicine
Principal Investigator Name
Monique Reijers
Principal Investigator Email
monique.reijers@radboudumc.nl
Contact Person Name
Monique Reijers
Contact Person Email
monique.reijers@radboudumc.nl

Spain

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
28
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Pulmonology
Principal Investigator Name
Montserrat Vendrell Realt
Principal Investigator Email
mvendrell.girona.ics@gencat.cat
Contact Person Name
Montserrat Vendrell Realt
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Pulmonology
Principal Investigator Name
Jessica Gonzalez Gutierrez
Principal Investigator Email
jdgonzalez.lleida.ics@gencat.cat
Contact Person Name
Jessica Gonzalez Gutierrez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Pulmonology
Principal Investigator Name
Eva Polverino
Principal Investigator Email
eva.polverino@vallhebron.cat
Contact Person Name
Eva Polverino
Contact Person Email
eva.polverino@vallhebron.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Pulmonology
Principal Investigator Name
Jose Echave-Susaeta María-Tomé
Principal Investigator Email
jose.echave@quironsalud.es
Contact Person Name
Jose Echave-Susaeta María-Tomé
Contact Person Email
jose.echave@quironsalud.es
Site Name
Hospital Clinic De Barcelona
Department Name
Pulmonology
Principal Investigator Name
Miguel Ferrer Monrreal
Principal Investigator Email
miferrer@clinic.cat
Contact Person Name
Miguel Ferrer Monrreal
Contact Person Email
miferrer@clinic.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pulmonology
Principal Investigator Name
Vanessa Riveiro Blanco
Principal Investigator Email
vanessa.ribeiro.blanco@sergas.es
Contact Person Name
Vanessa Riveiro Blanco
Site Name
Parc Sanitari Sant Joan De Deu
Department Name
Pulmonology
Principal Investigator Name
Alejandra López Giraldo
Principal Investigator Email
alejandra.lopez@sjd.es
Contact Person Name
Alejandra López Giraldo
Contact Person Email
alejandra.lopez@sjd.es
Site Name
Hospital San Pedro
Department Name
Pulmonology
Principal Investigator Name
Javier Ugedo Urruela
Principal Investigator Email
jugedo@rioja.salud.es
Contact Person Name
Javier Ugedo Urruela
Contact Person Email
jugedo@rioja.salud.es
Site Name
Hospital Universitario Rio Hortega
Department Name
Pulmonology
Principal Investigator Name
Tomás Ruiz Albi
Principal Investigator Email
truizal@saludcastillayleon.es
Contact Person Name
Tomás Ruiz Albi
Contact Person Email
truizal@saludcastillayleon.es

Denmark

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
58
Number Of Sites
7
Number Of Participants
21

Sites

Site Name
Region Sjaelland
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Christian Niels Meyer
Principal Investigator Email
cnm@regionsjaelland.dk
Contact Person Name
Christian Niels Meyer
Contact Person Email
cnm@regionsjaelland.dk
Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Finn Rasmussen
Principal Investigator Email
Finn.Rasmussen@rsyd.dk
Contact Person Name
Finn Rasmussen
Contact Person Email
Finn.Rasmussen@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Ulla Møller Weinreich
Principal Investigator Email
ulw@rn.dk
Contact Person Name
Ulla Møller Weinreich
Contact Person Email
ulw@rn.dk
Site Name
Sygehus Lillebaelt Vejle Sygehus
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Ole Hilberg
Principal Investigator Email
Ole.Hilberg@rsyd.dk
Contact Person Name
Ole Hilberg
Contact Person Email
Ole.Hilberg@rsyd.dk
Site Name
Aarhus University Hospital
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Andreas Fløe Hvass
Principal Investigator Email
andreas.floe@rm.dk
Contact Person Name
Andreas Fløe Hvass
Contact Person Email
andreas.floe@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Ingrid Titlestad
Principal Investigator Email
Ingrid.titlestad@rsyd.dk
Contact Person Name
Ingrid Titlestad
Contact Person Email
Ingrid.titlestad@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Department of Respiratory Diseases
Principal Investigator Name
Charlotte Suppli Ulrik
Principal Investigator Email
csulrik@dadlnet.dk
Contact Person Name
Charlotte Suppli Ulrik
Contact Person Email
csulrik@dadlnet.dk

Poland

Earliest CTIS Part Ii Submission Date
09-04-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
14
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Pratia S.A. Centrum Medyczne Pratia Katowice
Principal Investigator Name
Szymon Płaczek
Principal Investigator Email
szplaczek@pratia.pl
Contact Person Name
Szymon Płaczek
Contact Person Email
szplaczek@pratia.pl
Site Name
Screenmed Sp. z o.o.
Principal Investigator Name
Adam Nowiński
Principal Investigator Email
a.nowinski@screenmed.pl
Contact Person Name
Adam Nowiński
Contact Person Email
a.nowinski@screenmed.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Karina Witkiewicz
Principal Investigator Email
witkiewicz@twojaprzychodnia.com
Contact Person Name
Karina Witkiewicz
Site Name
SP ZOZ MSWiA Białystok
Department Name
Oddział Chorób Wewnętrznych i Gastroenterologii
Principal Investigator Name
Beata Kuklińska
Principal Investigator Email
beatakuklinska@op.pl
Contact Person Name
Beata Kuklińska
Contact Person Email
beatakuklinska@op.pl
Site Name
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
Principal Investigator Name
Anna Olech-Cudzik
Principal Investigator Email
annacudzik@cudmed.pl
Contact Person Name
Anna Olech-Cudzik
Contact Person Email
annacudzik@cudmed.pl
Site Name
PRATIA MCM Kraków
Principal Investigator Name
Marek Koprowski
Principal Investigator Email
mkoprowski@pratia.pl
Contact Person Name
Marek Koprowski
Contact Person Email
mkoprowski@pratia.pl
Site Name
Poliklinika Doktora Bessera
Principal Investigator Name
Krzysztof Filipek
Principal Investigator Email
christo50@wp.pl
Contact Person Name
Krzysztof Filipek
Contact Person Email
christo50@wp.pl
Site Name
Pratia S.A. Centrum Medyczne Pratia Bydgoszcz
Principal Investigator Name
Jacek Dulęba
Principal Investigator Email
jduleba@pratia.pl
Contact Person Name
Jacek Dulęba
Contact Person Email
jduleba@pratia.pl

Sponsor

Primary sponsor

Full Name
CSL Behring LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
Project/vendor support (sponsorDuties codes: 10)
Name
PPD Development LP
Responsibilities
Multiple operational responsibilities (sponsorDuties codes: 1,10,12,13,14,2,3,5,6,7,8)

Third parties

  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes: 14, 15 (Nebulizer, cleaner, replacement mesh and handset)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"sponsorDuties codes: 15 (Study portal system, study training for sponsor, sites and patients, public facing webpage)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"sponsorDuties codes: 15 (Translations)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,10,12,13,14,2,3,5,6,7,8 (multiple vendor responsibilities listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scarritt Group Inc.","duties_or_roles":"sponsorDuties codes: 15 (Investigator Meeting Planner)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"India","full_name":"Fortrea","duties_or_roles":"sponsorDuties codes: 15 (Adverse Event (AE) / SUSAR Reporting)","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"sponsorDuties codes: 15 (Patient emergency ID cards)","organisation_type":"Patient organisation/association"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Block Clinical Inc.","duties_or_roles":"sponsorDuties codes: 15 (patient concierge/Patient reimbursement/patient stipend service)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"sponsorDuties codes: 15 (Site payment)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"sponsorDuties codes: 15 (Centralized spirometry and ECG equipment and overread)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CSL787
Active Substance
HUMAN NORMAL IMMUNOGLOBULIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INHALATION
Route
INHALATION
Investigational Product Name
Placebo, inhalation solution
Modality
Other

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