Clinical trial • Phase II • Respiratory

ZAMPILIMAB for Idiopathic pulmonary fibrosis

Phase II trial of ZAMPILIMAB for Idiopathic pulmonary fibrosis. Randomised, 0.9% sodium chloride aqueous solution for iv infusion (placebo)-controlled.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Idiopathic pulmonary fibrosis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
16-12-2025
First CTIS Authorization Date
27-04-2026

Trial design

Randomised, 0.9% sodium chloride aqueous solution for iv infusion (placebo)-controlled Phase II trial in Belgium, Bulgaria, France and others.

Randomised
Yes
Comparator
0.9% sodium chloride aqueous solution for IV infusion (placebo)
Target Sample Size
140
Trial Duration For Participant
168

Eligibility

Recruits 140 Vulnerable population selected. Written informed consent from the participant is required prior to any study-related procedure (principal inclusion criterion 1). Subject information and ICF documents are provided in multiple country-specific languages; no specific assent/consent process for minors is provided in the available data..

Vulnerable Population
Vulnerable population selected. Written informed consent from the participant is required prior to any study-related procedure (principal inclusion criterion 1). Subject information and ICF documents are provided in multiple country-specific languages; no specific assent/consent process for minors is provided in the available data.

Inclusion criteria

  • {"criterion_text":"- 1. Informed consent: Participant’s written informed consent obtained prior to any study-related procedure.\n- 2. Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.\n- 3. Body weight ≥45 kg.\n- 4. Diagnosis of IPF: Diagnosis as defined by the 2018 and 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent HRCT(High-resolution computed tomography) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.\n- 5. Lung function: Forced vital capacity (FVC) ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second/FVC ≥0.7 at screening.\n- 6. Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.\n- 7. Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation [SpO2]) >90% when the maximum oxygen flow is 4 L/min by standard nasal cannula."}

Exclusion criteria

  • {"criterion_text":"- 1. Participant with a documented diagnosis of coeliac disease.\n- 2. Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defined as acute worsening or development of dyspnoea typically <1 month duration;\n- 3. Lung cancer: Active diagnosis or history of lung cancer.\n- 4. Emphysema: HRCT (refer to inclusion criterion #5 [Diagnosis of IPF]), reviewed by central reading, shows the presence of emphysema ≥50% or that the extent of emphysema is greater than the extent of fibrosis.\n- 5. Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.\n- 6. Other medical conditions: Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis/tuberculosis infection that may interfere with the participant’s ability to complete this study according to the Investigator’s judgement.\n- 7. Participant currently treated, or been treated with cytotoxic and immunosuppressant/modulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of >10 mg/day used for >10 days.\n- 8. Hypersensitivity: Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.\n- 9. History of allergic or anaphylactic reaction to human, humanised, chimeric Igs, or murine monoclonal antibodies."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Week 24","definition_or_measurement_approach":"To evaluate the efficacy of 2 dose strengths of CHF10067 in terms of change from baseline in percent predicted forced vital capacity (ppFVC) at Week 24 compared to placebo in the entire study population."}

Secondary endpoints

  • {"endpoint_text":"- 1- Efficacy thorughout the duration of the study at Weeks 0, 6, 12, 18, 24 and 30","definition_or_measurement_approach":"Efficacy assessments performed at Weeks 0, 6, 12, 18, 24 and 30 (as stated)."}
  • {"endpoint_text":"- 2 - Week 0 through to Week 21","definition_or_measurement_approach":"Assessment window described as Week 0 through to Week 21 (as stated)."}

Recruitment

Registry Or Advocacy Recruitment
Yes
Digital Remote Recruitment
True - online postings, video scripts, social media graphics (e.g., graphic for post, graphic for stories) and other digital materials are listed among recruitment materials for multiple countries.
Planned Sample Size
140
Recruitment Window Months
25
Consent Approach
Written informed consent required from the participant prior to any study-related procedures (principal inclusion criterion 1). Subject information and informed consent forms (L1 documents) are provided in country-specific languages (multiple country-specific ICFs listed). Pregnant participant/partner ICFs and genetic testing optional ICFs are provided where applicable. No specific assent procedure for minors is provided in the available materials.

Methods

  • Online postings (country-specific online posting materials listed for multiple countries)
  • Flyers and posters (patient-facing printed materials available in country-specific languages)
  • Patient letters and caregiver brochures (country-specific patient letter and caregiver brochure materials)
  • Health care professional (HCP) letters and HCP factsheets (materials for clinicians to support recruitment)
  • Advocacy factsheets (advocacy-targeted materials available)
  • Video scripts (video materials for recruitment) and featured trial templates
  • ICF Flipbook and study visit guides (materials to support participant information and consent)

Geography

Total Number Of Sites
63
Total Number Of Participants
95

Belgium

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
32
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Pulmonology
Contact Person Name
Caroline Dahlqvist
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Contact Person Name
Antoine Froidure
Site Name
Azorg
Department Name
Pneumology
Contact Person Name
Valerie Adam
Contact Person Email
valerie.adam@azorg.be
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
UZ Leuven
Department Name
Respiratory Medicine
Contact Person Name
Wim Wuyts
Contact Person Email
wim.wuyts@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Pneumology
Contact Person Name
Hannelore Bode
Contact Person Email
hannelore.bode@azdelta.be

Bulgaria

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
31
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Diagnostics And Consultation Center Convex Ltd.
Contact Person Name
Georgi Stoykov
Contact Person Email
drhinkov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Pneumology and Phthisiology Pulmonology Department
Contact Person Name
Vladimir Hodzhev
Site Name
Medical Center Pulmo-2018 EOOD
Contact Person Name
Veselin Kalfov
Contact Person Email
kalfov@abv.bg

France

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
45
Number Of Sites
12
Number Of Participants
14

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pulmonology
Contact Person Name
Jaques CADRANEL
Contact Person Email
jacques.cadranel@aphp.fr
Site Name
Hospital Foch
Department Name
Respiratory direases
Contact Person Name
Alexandre CHABROL
Contact Person Email
a.chabrol@hopital-foch.com
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Respiratory and Allergic Diseases
Contact Person Name
Sandra DURY
Contact Person Email
sdury@chu-reims.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Respiratory direases
Contact Person Name
Claire Andrejak
Contact Person Email
Andrejak.Claire@chu-amiens.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pulmonology
Contact Person Name
Hilario Nunes
Contact Person Email
hilario.nunes@aphp.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Pulmonology and Thoracic Oncology
Contact Person Name
Emmanuel Bergot
Contact Person Email
bergot-e@chu-caen.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Pulmonology
Contact Person Name
Bruno CRESTANI
Contact Person Email
bruno.crestani@aphp.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
Pulmonology
Contact Person Name
Quentin Gibiot
Contact Person Email
quentin.gibiot@chicreteil.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pulmonology, Thoracic Oncology, Allergology and Respiratory Care
Contact Person Name
Sylvie LEROY
Contact Person Email
leroy.s2@chu-nice.fr
Site Name
Hospices Civils De Lyon
Department Name
Pulmonology
Contact Person Name
Vincent COTTIN
Contact Person Email
vincent.cottin@chu-lyon.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Pulmonology department
Contact Person Name
Martine Reynaud-Gaubert
Contact Person Email
martine.reynaud@ap-hm.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Pulmonology
Contact Person Name
Sylvain Marchand-Adam
Contact Person Email
s.marchandadam@univ-tours.fr

Germany

Earliest CTIS Part Ii Submission Date
14-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
16
Number Of Sites
8
Number Of Participants
11

Sites

Site Name
IKF Pneumologie GmbH & Co. KG
Contact Person Name
Marc Oliver Kornmann
Contact Person Email
kornmann@ikf-pneumologie.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Med. Klinik, Abteilung für Pneumologie
Contact Person Name
Tim Oqueka
Contact Person Email
Pneumostudienzentrale@uke.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Med. Klinik II - Pneumologie
Contact Person Name
Andreas Günther
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Innere Medizin I
Contact Person Name
Jan Heyckendorf
Contact Person Email
Jan.heyckendorf@uksh.de
Site Name
Augustinerinnen Krankenhaeuser gGmbH
Department Name
Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin
Contact Person Name
Urte Sommerwerck
Site Name
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Department Name
Pneumologie
Contact Person Name
Francesco Bonella
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin V
Contact Person Name
Albert Omlor
Contact Person Email
Albert.Omlor@uks.eu
Site Name
Klinikum Konstanz GmbH
Department Name
Medizinische KlinikStudienzentrum
Contact Person Name
Stephan Walterspacher
Contact Person Email
Stephan.walterspacher@glkn.de

Italy

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
34
Number Of Sites
10
Number Of Participants
14

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
UOC Pneumologia
Contact Person Name
Pierachille Santus
Contact Person Email
pierachille.santus@unimi.it
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Respiratory Unit
Contact Person Name
Michele Mondoni
Contact Person Email
michele.mondoni@unimi.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
UOC Malattie dell’Apparato Respiratorio e Trapianto Polmonare
Contact Person Name
Elena Bargagli
Contact Person Email
bargagli2@unisi.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di Malattie dell’Apparato Respiratorio
Contact Person Name
Stefania Cerri
Contact Person Email
stefania.cerri@unimore.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Pneumology Unit
Contact Person Name
Fabrizio Luppi
Contact Person Email
Fabrizio.luppi@unimib.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Respiratory Diseases Unit - “Colonnello D’Avanzo” Hospital
Contact Person Name
Donato Lacedonia
Contact Person Email
donato.lacedonia@unifg.it
Site Name
University Hospital Of Ferrara
Department Name
Arcispedale Sant'Anna, Ferrara - Pneumology Unit
Contact Person Name
Lucia Vietri
Contact Person Email
lucia.vietri@ospfe.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
UOC Pneumology
Contact Person Name
Claudio Micheletto
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Pneumologia
Contact Person Name
Paolo Spagnolo
Contact Person Email
paolo.spagnolo@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Pneumologia
Contact Person Name
Luca Richeldi

Portugal

Earliest CTIS Part Ii Submission Date
11-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
48
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Pulmonology Unit
Contact Person Name
João Pedro Abreu Cravo
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Pulmonary Medicine
Contact Person Name
Tiago Alfaro
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Pulmonology Unit
Contact Person Name
Maria Da Conceição Mendes Godinho De Alvarenga Santos

Spain

Earliest CTIS Part Ii Submission Date
31-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
30
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
Hospital Universitario Infanta Leonor
Department Name
Servicio de Neumología
Contact Person Name
Maria Belen Lopez- Muniz Ballesteros
Contact Person Email
belenlmb@yahoo.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Servicio de Neumología
Contact Person Name
Jose Ros Lucas
Contact Person Email
jarl77@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Neumología
Contact Person Name
Ana Villar Gomez
Contact Person Email
ana.villar@vallhebron.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Servicio de Neumología
Contact Person Name
Juan Luis Suarez- Antelo
Contact Person Email
juan.suarez.antelo@sergas.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Neumología
Contact Person Name
Jose Velasco Garrido
Site Name
Hospital Clinic De Barcelona
Department Name
Servicio de Neumología
Contact Person Name
Fernanda Hernandez Gonzalez
Contact Person Email
fhernandez@clinic.cat
Site Name
Bellvitge University Hospital
Department Name
Servicio de Neumología
Contact Person Name
Maria Molina-Molina
Contact Person Email
mariamolinamolina@hotmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Servicio de Neumología
Contact Person Name
Sergio Miguel Curi Chercoles
Contact Person Email
scuriche@navarra.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Neumología
Contact Person Name
Jose Manuel Cifrian Martínez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital General De Granollers
Department Name
Servicio de Neumología
Contact Person Name
Jaume Bordas Martinez
Contact Person Email
jbordas@fphag.org

Netherlands

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
31
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary medicine
Contact Person Name
Thomas Koudstaal
Contact Person Email
poli.longziekten@erasmusmc.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Pulmonary medicine
Contact Person Name
Remy Mostard
Contact Person Email
communicatie@zuyderland.nl
Site Name
Gelre Hospitals
Department Name
Pulmonary medicine
Contact Person Name
Martijn Goosens
Contact Person Email
info@gelre.nl

Poland

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
14
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie
Department Name
Oddział Gruźlicy i Chorób PłucI
Contact Person Name
Małgorzata Noceń- Piskorowska
Site Name
Gyncentrum Sp. z o.o.
Department Name
NZOZ Holsamed- Oddział Libero
Contact Person Name
Marta Frejowska-Reniecka
Site Name
National Institute Of Tuberculosis And Lung Diseases
Department Name
Klinika Chorób Płuc
Contact Person Name
Katarzyna Lewandowska
Contact Person Email
1klinika@igichp.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddział Kliniczny Pulmonologii Alergologii z PododdziałemChorób Wewnętrznych
Contact Person Name
Wojciech Piotrowski

Czechia

Earliest CTIS Part Ii Submission Date
16-04-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
12
Number Of Sites
4
Number Of Participants
7

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Pneumologická klinika
Contact Person Name
Martina Šterclová
Contact Person Email
martina.sterclova@ftn.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika nemocí plicních a tuberkulózy
Contact Person Name
Martina Doubková
Contact Person Email
doubkova.martina@fnbrno.cz
Site Name
Odborna plicni ambulance Opava s.r.o.
Contact Person Name
Zdeněk Heralt
Contact Person Email
heraltz@seznam.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicních nemocí a tuberkulózy
Contact Person Name
Monika Žurková
Contact Person Email
monika.zurkova@fnol.cz

Sponsor

Primary sponsor

Full Name
Chiesi Farmaceutici S.p.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Contract research organisations

Name
Icon Public Limited Company
Responsibilities
codes 1,10,11,12,13,15 (CRO, Particpants travel arragments and reimbursement, eCoAs),2,3,4,5,6,8

Third parties

  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"code 15 (long term storage of samples)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"SGS Analytics Switzerland AG","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"codes 1,10,11,12,13,15 (CRO, Participants travel arragments and reimbursement, eCoAs),2,3,4,5,6,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CHF10067 (zampilimab)
Active Substance
ZAMPILIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Investigational medicinal product (IMP)
Maximum Dose
3000 mg (max daily dose amount as provided)
Investigational Product Name
0.9% sodium chloride aqueous solution for IV infusion
Modality
Other
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Comparator/placebo (0.9% sodium chloride for IV infusion) - MIA/authorisation reference provided

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