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
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
-
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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