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Clinical Trials in the UK / NCT06736990
Active, not recruiting Phase 2

A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

NCT06736990 · tracked via the Priya Life Science UK tracker
Sponsor
Calluna Pharma AS
Phase
Phase 2
Started
2025-06-20
Last updated
2026-04-27

Condition(s) studied

Idiopathic Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

CAL101Placebo

CAL101: Intravenous infusions of CAL101 every 4 weeks over 24 weeks

Placebo: Intravenous infusions of placebo every 4 weeks over 24 weeks

Study summary

The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis.

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * ≥ 40 years of age * 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 (at Screening). * Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted. * Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.70 at Screening or FEV1/FVC ≥ predicted value minus 0.10 (if predicted value according to the spirometry report at Screening is \<0.80). * 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. Exclusion Criteria: * 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. * 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

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Keck School of Medicine at USC Los Angeles California
National Jewish Health Denver Colorado
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research Miami Florida
University of Kansas Medical Center Kansas City Kansas
Pulmonix, LLC Greensboro North Carolina
Southeastern Research Center Winston-Salem North Carolina
Cleveland Clinic Cleveland Ohio
Temple University Hospital Philadelphia Pennsylvania
University of Utah Health Salt Lake City Utah
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 Padova PD
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Roma RM
Azienda Ospedaliero Universitaria Senese Siena SI
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara Trieste TS
Azienda Ospedaliero-Universitaria di Modena Modena Italy
AORN - Ospedali dei Colli - Ospedale V. Monaldi Naples Italy
Istituto Clinico Humanitas - Pneumologia 1 Rozzano Italy
Erasmus MC Rotterdam South Holland
St. Antonius Ziekenhuis - Locatie Nieuwegein Nieuwegein Utrecht
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
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova Craiova Dolj
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara Timișoara Timiș County
Institutul de Pneumoftiziologie Marius Nasta Bucharest Romania
Ajou University Hospital Suwon Gyeonggi-do
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

+ 14 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06736990 on ClinicalTrials.gov ↗ ← All trials in the UK