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

Phase 2

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: CAL101; Drug: Placebo

• Registration Number: NCT06736990
• Lead Sponsor: Calluna Pharma AS

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 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Study Start: 2025-05
• Primary Completion: 2027-08
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAL101	CAL101	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in forced vital capacity (FVC) compared to placebo	28 weeks