Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2INTERVENTIONAL

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

A Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥ 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

CAL101

Intravenous infusions of CAL101 every 4 weeks over 24 weeks

DRUG

Placebo

Intravenous infusions of placebo every 4 weeks over 24 weeks

Locations (20)

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
Padova, PD, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, RM, Italy
Azienda Ospedaliero Universitaria Senese
Siena, SI, Italy