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

NCT06736990 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CAL101

Intravenous infusions of CAL101 every 4 weeks over 24 weeks

DRUG

Placebo

Intravenous infusions of placebo every 4 weeks over 24 weeks

Sponsors & Collaborators

  • Calluna Pharma AS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-11-30
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • France
  • Italy
  • Netherlands
  • Norway
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736990 on ClinicalTrials.gov