EU-IPFF committed to promoting research in Pulmonary Fibrosis

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion 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.

- Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted.

- Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.7.

- Either stable dose with antifibrotics (either nintedanib or pirfenidone) 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) 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06736990
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Calluna Pharma AS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, taking and not taking background therapy (i.e. nintedanib or pirfenidone). The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.

Arms & Interventions

Arms

Experimental: CAL101

Placebo Comparator: Placebo

Interventions

Drug: - CAL101

Intravenous infusions of CAL101 every 4 weeks over 24 weeks

Drug: - Placebo

Intravenous infusions of placebo every 4 weeks over 24 weeks

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Charlotte Kleiveland

[email protected]

+4740857584

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Powered By

Clinical Trial Finder