CAL101 for Pulmonary Fibrosis

(AURORA Trial)

Overseen By Charlotte Kleiveland

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Calluna Pharma AS

Must be taking: Antifibrotics

Disqualifiers: Asthma, Emphysema, COPD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

My recent lung scan shows a specific type of lung scarring.

My lung function is at least 45% of what is expected.

My IPF diagnosis is confirmed by a detailed chest scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive an IV infusion of CAL101 or placebo once every 4 weeks

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

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?

Group I: CAL101 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Calluna Pharma AS

Lead Sponsor

Trials

1

Recruited

150+