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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518339-12-00

Acronym

CAL101-201

Enrollment

Registered

2025-06-24

Start date

2025-07-08

Completion date

Unknown

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

Absolute change from baseline in FVC (mL) through 28 weeks (repeated measures) confirmed by central read of FVC.

Detailed description

Percentage of patients with adverse events (AEs) through 40 weeks., Change from baseline in % predicted FVC through 28 weeks (repeated measures) confirmed by central reading of FVC. For additional secondary end points pls refer to the Protocol.

Interventions

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in FVC (mL) through 28 weeks (repeated measures) confirmed by central read of FVC.	—

Secondary

Measure	Time frame
Percentage of patients with adverse events (AEs) through 40 weeks., Change from baseline in % predicted FVC through 28 weeks (repeated measures) confirmed by central reading of FVC. For additional secondary end points pls refer to the Protocol.	—

Countries

Denmark, France, Italy, Netherlands, Norway, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026