Status:
RECRUITING
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Calluna Pharma AS
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, either as standalone treatment or in addition to currently approved...
Eligibility Criteria
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
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06736990
Start Date
June 20 2025
End Date
November 1 2027
Last Update
March 13 2026
Active Locations (54)
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1
Keck School of Medicine at USC
Los Angeles, California, United States, 90033
2
National Jewish Health
Denver, Colorado, United States, 80206
3
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, Florida, United States, 33144
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160