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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT06736990

Run by

Calluna Pharma AS

People needed

150

Starts

2025-06-20

Expected to finish

2027-02-01

Last updated by the study team

2026-04-27

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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

Where it is running

• 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 — Padova, 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 — Naples, Italy
• Istituto Clinico Humanitas - Pneumologia 1 — Rozzano, Italy
• Erasmus MC — Rotterdam, South Holland, Netherlands
• Keck School of Medicine at USC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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