Clinical trial • Phase II • Respiratory

CAL101 for Idiopathic pulmonary fibrosis

Phase II trial of CAL101 for Idiopathic pulmonary fibrosis.

Overview

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

Key dates

Initial CTIS Submission Date
28-02-2025
First CTIS Authorization Date
24-06-2025

Trial design

Randomised, placebo (sodium chloride iv solution; dosing unit millilitre(s)/kilogram; max daily 0.8 ml/kg; max total 5.6 ml/kg; route: intravenous).-controlled Phase II trial across 30 sites in Italy, Norway, Denmark and others.

Randomised
Yes
Comparator
Placebo (SODIUM CHLORIDE IV solution; dosing unit millilitre(s)/kilogram; max daily 0.8 mL/kg; max total 5.6 mL/kg; route: intravenous).
Target Sample Size
63
Trial Duration For Participant
280

Eligibility

Recruits 63 No vulnerable population selected; participants are adults (≥40 years). Informed consent is required using subject information sheets and informed consent forms (multiple country-specific versions available). No assent process for minors is described..

Vulnerable Population
No vulnerable population selected; participants are adults (≥40 years). Informed consent is required using subject information sheets and informed consent forms (multiple country-specific versions available). No assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- 1. ≥ 40 years of age (at the time of informed consent).\n- 2. IPF diagnosis according to current international criteria.\n- 3. Definite or probably usual interstitial pneumonia (UIP) pattern on chest HRCT performed within 12 months of enrolment, confirmed by central review (if an evaluable HRCT < 12 months is not available, the baseline HRCT will be used to determine eligibility).\n- 4. Forced vital capacity (FVC) ≥ 45% of predicted (at Screening).\n- 5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin ≥ 25% predicted.\n- 6. Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.70 or ≥ (predicted value minus 0.10) (if predicted value is <0.80) (at Screening)\n- 7. Either stable dose with an approved antifibrotic for at least 8 weeks prior to screening or not treated with antifibrotics for at least 8 weeks prior to screening. Patients on antifibrotic should be anticipated to stay on the antifibrotic throughout the trial. For additional Inclusion Criteria pls refer to the Protocol"}

Exclusion criteria

  • {"criterion_text":"- 1. In the opinion of the Investigator, other clinically significant lung disease (e.g. asthma, emphysema, chronic obstructive pulmonary disease, cavitary or pleural diseases , clinically significant or treatment-requiring pulmonary hypertension) at screening.\n- 2. Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).\n- 3. Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).\n- 4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.\n- 5.Evidence of impaired kidney function, unstable cardiovascular disease, moderate or severe hepatic impairment or any significant disease or condition other than IPF which may interfere with trial procedures or interpretation of trial results, or cause concern regarding the patient’s ability to participate in the trial or any medical condition which could lead to a life expectancy < 12months."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Absolute change from baseline in FVC (mL) through 28 weeks (repeated measures) confirmed by central read of FVC.","definition_or_measurement_approach":"Absolute change in forced vital capacity (FVC) measured in mL over 28 weeks using repeated measures and confirmed by central reading of FVC."}

Secondary endpoints

  • {"endpoint_text":"- Percentage of patients with adverse events (AEs) through 40 weeks.","definition_or_measurement_approach":"Proportion (%) of patients reporting adverse events during the 40-week observation period."}
  • {"endpoint_text":"- Change from baseline in % predicted FVC through 28 weeks (repeated measures) confirmed by central reading of FVC. For additional secondary end points pls refer to the Protocol.","definition_or_measurement_approach":"Change from baseline in percent predicted FVC over 28 weeks assessed by repeated measures and confirmed by central reading."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
63
Recruitment Window Months
29
Consent Approach
Informed consent obtained from adult participants (≥40 years) using subject information sheets and informed consent forms. Country-specific ICF versions and translations are provided (examples of available ICFs and synopses in English, Romanian, French, Italian, Dutch, Spanish and Norwegian are present among the submitted documents). No assent process for minors is described.

Methods

  • Country-specific recruitment arrangements (K1) documents
  • Brochure/printed recruitment material (K2) for potential participants
  • Study video and study video script for participant information
  • Website package / online recruitment materials
  • Posters and participant posters for site display

Geography

Total Number Of Sites
30
Total Number Of Participants
87

Italy

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
281
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Internal Medicine - Pulmonology 1
Principal Investigator Name
Francesco Amati
Principal Investigator Email
francesco.amati@hunimed.eu
Contact Person Name
Francesco Amati
Contact Person Email
francesco.amati@hunimed.eu
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Unit of Rare Respiratory Disease
Principal Investigator Name
Anna Agnese Stanziola
Principal Investigator Email
annaagnese.stanziola@unina.it
Contact Person Name
Anna Agnese Stanziola
Contact Person Email
annaagnese.stanziola@unina.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Complex Operational Unit of Pulmonology - Neuroscience, Sensory organs and Chest
Principal Investigator Name
Luca Richeldi
Principal Investigator Email
luca.richeldi@policlinicogemelli.it
Contact Person Name
Luca Richeldi
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Pulmonology
Principal Investigator Name
Marco Confalonieri
Principal Investigator Email
marco.confalonieri@asugi.sanita.fvg.it
Contact Person Name
Marco Confalonieri
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Section of Respiratory Disease and Center in rare lung diseases
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
Azienda Ospedaliera di Padova
Department Name
UOC Pneumologia
Principal Investigator Name
Paolo Spagnolo
Principal Investigator Email
paolo.spagnolo@unipd.it
Contact Person Name
Paolo Spagnolo
Contact Person Email
paolo.spagnolo@unipd.it
Site Name
Azienda Ospedaliero-Universitaria Senese
Department Name
UOC Malattie dell'Apparato Respiratorio e Trapianto Polmone
Principal Investigator Name
Paolo Cameli
Principal Investigator Email
paolo.cameli@ao-siena.toscana.it
Contact Person Name
Paolo Cameli
Site Name
Azienda Ospedaliera di Padova (duplicate entry not expected)
Department Name
UOC Pneumologia
Principal Investigator Name
Paolo Spagnolo
Principal Investigator Email
paolo.spagnolo@unipd.it
Contact Person Name
Paolo Spagnolo
Contact Person Email
paolo.spagnolo@unipd.it

Norway

Earliest CTIS Part Ii Submission Date
09-06-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
263
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Helse Bergen HF
Department Name
Haukeland University Hospital
Principal Investigator Name
Solveig Tangedal
Principal Investigator Email
solveig.tangedal@helse-bergen.no
Contact Person Name
Solveig Tangedal
Site Name
Oslo University Hospital HF
Department Name
University Hospital - Rikshospitalet
Principal Investigator Name
Monica Dahl Syrstad
Principal Investigator Email
modbjo@ous-hf.no
Contact Person Name
Monica Dahl Syrstad
Contact Person Email
modbjo@ous-hf.no
Site Name
Nordlandssykehuset HF
Department Name
Nordland Hospital Bodø
Principal Investigator Name
Marit Bjørnå Wilskow
Principal Investigator Email
postmottak@nordlandssykehuset.no
Contact Person Name
Marit Bjørnå Wilskow
Site Name
Akershus University Hospital
Department Name
Akershus University Hospital, Lørenskog
Principal Investigator Name
Ragnhild Gagama
Principal Investigator Email
Ragnhild.Gagama@ahus.no
Contact Person Name
Ragnhild Gagama
Contact Person Email
Ragnhild.Gagama@ahus.no

Denmark

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
261
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Copenhagen University Hospital
Department Name
The Cardiology Research Unit, Section for Lung Transplantation and Pulmonary Diseases
Principal Investigator Name
Thomas Kromann Lund
Principal Investigator Email
thomas.kromann.lund@regionh.dk
Contact Person Name
Thomas Kromann Lund
Contact Person Email
thomas.kromann.lund@regionh.dk
Site Name
Aarhus University Hospital
Department Name
Department of Respiratory Diseases and Allergy,Palle Juul Jensens Boulevard 99, Indgang G3
Principal Investigator Name
Elisabeth Karen Martha Bendstrup
Principal Investigator Email
karbends@rm.dk
Contact Person Name
Elisabeth Karen Martha Bendstrup
Contact Person Email
karbends@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Respiratory Medicine, Kløvervænget 2, Indgang 87-88
Principal Investigator Name
Ingrid Louise Titlestad
Principal Investigator Email
ingrid.titlestad@rsyd.dk
Contact Person Name
Ingrid Louise Titlestad
Contact Person Email
ingrid.titlestad@rsyd.dk

Netherlands

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
268
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Pulmonology
Principal Investigator Name
Marcel Veltkamp
Principal Investigator Email
m.veltkamp@antoniusziekenhuis.nl
Contact Person Name
Marcel Veltkamp
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Pulmonary Medicine
Principal Investigator Name
Marlies Wijsenbeek
Principal Investigator Email
m.wijsenbeek-lourens@erasmusmc.nl
Contact Person Name
Marlies Wijsenbeek

Spain

Earliest CTIS Part Ii Submission Date
09-06-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
263
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Respiratory
Principal Investigator Name
Ana Villar Gomez
Principal Investigator Email
ana.villar@vallhebron.cat
Contact Person Name
Ana Villar Gomez
Contact Person Email
ana.villar@vallhebron.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pulmonology
Principal Investigator Name
Juan Suarez Antelo
Principal Investigator Email
juan.suarez.antelo@sergas.es
Contact Person Name
Juan Suarez Antelo
Contact Person Email
juan.suarez.antelo@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Pneumology
Principal Investigator Name
Jose Manuel Cifrian Martinez
Principal Investigator Email
josemanuel.cifrian@scsalud.es
Contact Person Name
Jose Manuel Cifrian Martinez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Respiratory Medicine
Principal Investigator Name
Diego Castillo Villegas
Principal Investigator Email
DCastillo@santpau.cat
Contact Person Name
Diego Castillo Villegas
Contact Person Email
DCastillo@santpau.cat

Romania

Earliest CTIS Part Ii Submission Date
10-06-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
262
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Department Name
Sectia Clinica Pneumologie I
Principal Investigator Name
Milena Adina Man
Principal Investigator Email
spital_pneumo@yahoo.com
Contact Person Name
Milena Adina Man
Contact Person Email
spital_pneumo@yahoo.com
Site Name
Institutul De Pneumoftiziologie Marius Nasta
Department Name
Sectia Clinica Pneumologie 5
Principal Investigator Name
Irina Ruxandra Strambu
Principal Investigator Email
secretariat@marius-nasta.ro
Contact Person Name
Irina Ruxandra Strambu
Contact Person Email
secretariat@marius-nasta.ro
Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Clinica Universitara de Pneumologie
Principal Investigator Name
Ovidiu Fira-Mladinescu
Principal Investigator Email
oancea@umft.ro
Contact Person Name
Ovidiu Fira-Mladinescu
Contact Person Email
oancea@umft.ro
Site Name
Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova
Department Name
Departamentul Ambulatoriul de Pneumologie
Principal Investigator Name
Dragos Nicolosu
Principal Investigator Email
spital@vbabes-cv.ro
Contact Person Name
Dragos Nicolosu
Contact Person Email
spital@vbabes-cv.ro

France

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
343
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
CHRU Tours Hopital Bretonneau
Department Name
Pneumology
Principal Investigator Name
Sylvain MARCHAND-ADAM
Principal Investigator Email
sylvain.marchand-adam@univ-tours.fr
Contact Person Name
Sylvain MARCHAND-ADAM
Site Name
CHU de Toulouse – Hôpital Larrey
Department Name
Pneumology
Principal Investigator Name
Gregoire PREVOT
Principal Investigator Email
prevot.g@chu-toulouse.fr
Contact Person Name
Gregoire PREVOT
Contact Person Email
prevot.g@chu-toulouse.fr
Site Name
CHU Rennes Pontchaillou Hospital
Department Name
Pneumology
Principal Investigator Name
Stephane JOUNEAU
Principal Investigator Email
Stephane.JOUNEAU@chu-rennes.fr
Contact Person Name
Stephane JOUNEAU
Contact Person Email
Stephane.JOUNEAU@chu-rennes.fr
Site Name
Hopital Europeen Georges Pompidou
Department Name
Pneumology
Principal Investigator Name
Jean PASTRE
Principal Investigator Email
Jean.pastre@aphp.fr
Contact Person Name
Jean PASTRE
Contact Person Email
Jean.pastre@aphp.fr
Site Name
Hôpital Avicenne
Department Name
Pneumology
Principal Investigator Name
Hilario NUNES
Principal Investigator Email
hilario.nunes@aphp.fr
Contact Person Name
Hilario NUNES
Contact Person Email
hilario.nunes@aphp.fr

Sponsor

Primary sponsor

Full Name
Calluna Pharma AS
Organisation Type
Pharmaceutical company
Country Of Registered Address
Norway

Third parties

  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: RBM_ProjectManagement@q2labsolutions.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Alderley Analytical Limited","duties_or_roles":"additional PK analysis (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Birka BioStorage AB","duties_or_roles":"laboratory samples storage (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Spirometry Lab (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties code: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Qureight Limited","duties_or_roles":"medical image analyses review (sponsorDuties code 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"sponsorDuties code: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"sponsorDuties code: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited (Almag House, Armagh)","duties_or_roles":"sponsorDuties code: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"sponsorDuties code: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"multiple sponsorDuties codes: [1,12,2,4,5,6,7,8,9]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CAL101
Active Substance
CAL101
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
20 mg/kg (max daily); 140 mg/kg (max total)
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Maximum Dose
0.8 mL/kg (max daily); 5.6 mL/kg (max total)
Combination Treatment
Yes

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