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A Phase 2 Study of CAL101 in Patients with Idiopathic Pulmonary Fibrosis
EU CTIS ID: 2024-518339-12-00
What this study is testing
To investigate the efficacy of CAL101 administered intravenously (IV) as evaluated by change from baseline in forced vital capacity (FVC) compared to placebo over 28 weeks for the treatment of patients with idiopathic pulmonary fibrosis (IPF)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. ≥ 40 years of age (at the time of informed consent).
- 2. IPF diagnosis according to current international criteria.
- 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).
- 4. Forced vital capacity (FVC) ≥ 45% of predicted (at Screening).
- 5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin ≥ 25% predicted.
- 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)
You likely can't join if
- 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.
- 2. Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).
- 3. Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).
- 4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
- 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.
See the full eligibility criteria
- 1. ≥ 40 years of age (at the time of informed consent).
- 2. IPF diagnosis according to current international criteria.
- 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).
- 4. Forced vital capacity (FVC) ≥ 45% of predicted (at Screening).
- 5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin ≥ 25% predicted.
- 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)
- 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
- 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.
- 2. Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).
- 3. Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).
- 4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Turkey
- Korea, Republic of
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Turkey; Korea, Republic of; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.