RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-20

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06736990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Charlotte Kleiveland

CONTACT

+4740857584

info@callunapharma.com

Study Locations (Sites)

Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research

Miami, Florida, 33144

United States

Collaborators and Investigators

Sponsor: Calluna Pharma AS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-20

Study Completion Date2027-11

Study Record Updates

Study Start Date2025-06-20

Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis