A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT06736990
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-06-20
2027-11-30
Brief Summary
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Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC).
Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.
Detailed Description
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The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CAL101
CAL101
Intravenous infusions of CAL101 every 4 weeks over 24 weeks
Placebo
Placebo
Intravenous infusions of placebo every 4 weeks over 24 weeks
Interventions
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CAL101
Intravenous infusions of CAL101 every 4 weeks over 24 weeks
Placebo
Intravenous infusions of placebo every 4 weeks over 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of IPF supported by centrally read chest high-resolution computed tomography
* Definite or probable usual interstitial pneumonia (UIP) pattern on chest high-resolution computed tomography (HRCT) performed within 12 months of screening, confirmed by central review (if an evaluable HRCT \< 12 months is not available, the baseline HRCT will be used to determine eligibility).
* FVC ≥ 45% of predicted.
* Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted.
* Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.7
* Either stable dose with antifibrotics (either nintedanib or pirfenidone) for at least 8 weeks prior to screening or not treated with antifibrotics for at least 8 weeks prior to screening.
Exclusion Criteria
* Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).
* Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).
* Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
* 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
40 Years
ALL
No
Sponsors
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Calluna Pharma AS
INDUSTRY
Responsible Party
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Locations
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Keck School of Medicine at USC
Los Angeles, California, United States
National Jewish Health
Denver, Colorado, United States
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Pulmonix, LLC
Greensboro, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Utah Health
Salt Lake City, Utah, United States
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
AP-HP Hopital Avicenne
Bobigny, , France
AP-HP Hopital Europeen Georges Pompidou
Paris, , France
CHU Rennes - Hopital Pontchaillou
Rennes, , France
CHU de Toulouse - Hopital Larrey
Toulouse, , France
CHRU de Tours - Hôpital Bretonneau
Tours, , France
Azienda Ospedale - Università Padova
Padua, PD, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, RM, Italy
Azienda Ospedaliero Universitaria Senese
Siena, SI, Italy
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, TS, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
AORN - Ospedali dei Colli - Ospedale V. Monaldi
Napoli, , Italy
Istituto Clinico Humanitas - Pneumologia 1
Rozzano, , Italy
Erasmus MC
Rotterdam, South Holland, Netherlands
St. Antonius Ziekenhuis - Locatie Nieuwegein
Nieuwegein, Utrecht, Netherlands
Haukeland University Hospital
Bergen, , Norway
Akershus University Hospital
Lørenskog, , Norway
Oslo University Hospital, Rikshospitalet
Oslo, , Norway
Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''
Cluj-Napoca, Cluj, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova
Craiova, Dolj, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara
Timișoara, Timiș County, Romania
Institutul de Pneumoftiziologie Marius Nasta
Bucharest, , Romania
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
University of Health Sciences Gulhane Faculty of Medicine
Ankara, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Ege University Medical Faculty Hospital
Izmir, , Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
NHS Lothian, Edinburgh Royal Infirmary
Edinburgh, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Borchert SV, Hallen J, Hussain RI, Holyer I, Troelsen JT, Klingelhofer J. Development of CAL101-a humanized monoclonal antibody targeting S100A4 to inhibit proinflammatory and profibrotic signaling. J Pharmacol Exp Ther. 2025 Sep 24;392(11):103722. doi: 10.1016/j.jpet.2025.103722. Online ahead of print.
Other Identifiers
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2024-518339-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
CAL101-201
Identifier Type: -
Identifier Source: org_study_id