NCT06736990

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Calluna Pharma AS · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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, either as standalone treatment or in addition to currently approved antifibrotic treatments.. The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 or placebo once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	CAL101	Intravenous infusions of CAL101 every 4 weeks over 24 weeks
DRUG	Placebo	Intravenous infusions of placebo every 4 weeks over 24 weeks

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-08-01
• Completion: 2027-11-01
• First posted: 2024-12-17
• Last updated: 2026-03-13

Locations

54 sites across 11 countries: United States, Denmark, France, Italy, Netherlands, Norway, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study