CAL101 for Pulmonary Fibrosis
(AURORA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the drug CAL101 can slow lung damage in people with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. Participants will receive either CAL101 or a placebo (a non-active substance) through an IV once a month for six months. The main goal is to determine if CAL101 maintains lung function better than the placebo. Suitable candidates have had IPF confirmed by a recent chest scan and are either on a stable dose of certain lung medications or have not used them for a while. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on antifibrotics like nintedanib or pirfenidone, you must have been on a stable dose for at least 8 weeks before joining the trial or not have taken them for at least 8 weeks.
Is there any evidence suggesting that CAL101 is likely to be safe for humans?
Research has shown that CAL101 is safe and generally well-tolerated. In earlier studies, patients taking CAL101 experienced very few serious side effects, and most managed the treatment well. Researchers found that the drug performed as expected on certain biological markers related to lung health, indicating that CAL101 functions as intended without causing major harm.
Since this study is in its early stages, it primarily focuses on ensuring the treatment's safety for people. So far, CAL101 appears both safe and potentially effective for patients with Idiopathic Pulmonary Fibrosis.12345Why do researchers think this study treatment might be promising for pulmonary fibrosis?
Researchers are excited about CAL101 for pulmonary fibrosis because it targets a new pathway in the disease process that's not addressed by current treatments like pirfenidone and nintedanib. Unlike these medications, which primarily work by slowing down fibrous tissue formation, CAL101 aims to interrupt specific cellular signaling pathways that lead to fibrosis. This novel mechanism could potentially offer a more effective way to manage or even halt the progression of pulmonary fibrosis, offering hope for improved outcomes in patients.
What evidence suggests that CAL101 might be an effective treatment for pulmonary fibrosis?
Research has shown that CAL101, which participants in this trial may receive, might slow the worsening of lung function in people with Idiopathic Pulmonary Fibrosis (IPF). Early lab studies found that CAL101, an antibody, targets a protein called S100A4. This action helps reduce scarring and swelling in the lungs. In simpler terms, it might help prevent the lungs from deteriorating over time. Previous studies with people found that CAL101 was safe and well-tolerated by patients. While more research is needed to confirm its effectiveness, these early findings are encouraging.12678
Are You a Good Fit for This Trial?
Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) can join this trial. They must have a certain level of lung function and not be on antifibrotic drugs or stable on them for at least 8 weeks. A recent HRCT scan is required to confirm their diagnosis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an IV infusion of CAL101 or placebo once every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAL101
Trial Overview
The study tests if CAL101 can slow down lung function decline in IPF patients compared to a placebo. Participants will receive monthly IV infusions of either CAL101 or placebo for six months, with their lung capacity measured before and after.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Calluna Pharma AS
Lead Sponsor
Citations
A Phase 2 Study of CAL101 in Patients With Idiopathic ...
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 ...
2.
pulmonaryfibrosis.org
pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline/drug/idiopathic-pulmonary-fibrosis/cal101CAL101
This study is a randomized, double-blind, phase 2, placebo-controlled study on the safety and efficacy of CAL101 in participants with idiopathic pulmonary ...
First Patients Dosed in CAL101 Phase 2 IPF Trial
Previous phase 1 studies showed CAL101 to have a favorable safety profile. Moreover, preclinical data indicate its potential to prevent and ...
Therapeutic Potential of CAL101: A S100A4 Neutralizing ...
CAL101, an anti-S100A4 neutralizing monoclonal antibody significantly reduces fibrosis and inflammation in complementary preclinical and translational model ...
5.
ctv.veeva.com
ctv.veeva.com/study/a-randomized-double-blind-trial-to-evaluate-the-efficacy-and-safety-of-cal101-in-patients-with-idiopA Phase 2 Study of CAL101 in Patients With Idiopathic ...
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 ...
American Journal of Respiratory and Critical Care Medicine
CONCLUSIONS: CAL101 was safe, well tolerated and achieved exposures providing complete target saturation. Suppression of fibrosis biomarkers pSTAT3 and tenascin ...
Development of CAL101 - a Humanized Monoclonal ...
CAL101 serves as a dual-action inhibitor of S100A4, effectively mitigating its role in driving pro-inflammatory and pro-fibrotic responses, with ...
A Phase 2 Study of CAL101 in Patients With Idiopathic ...
A Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of CAL101 in Patients With Idiopathic Pulmonary Fibrosis. Estimated trial completion date.
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