AURORA
Research type
Research Study
Full title
A Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of CAL101 in Patients with Idiopathic Pulmonary Fibrosis
IRAS ID
1011201
Contact name
Margrethe Sorgaard
Contact email
Sponsor organisation
Calluna Pharma AS
Clinicaltrials.gov Identifier
Research summary
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive lung disease which causes scarring of the lung tissue which affects lung function making it difficult for patients to breathe. There is no cure for IPF, with available treatments aiming to slow disease progression and manage symptoms. New treatment options are vital for improving the quality of life for people with IPF.
The purpose of this study is to compare the effects of the research medicine, CAL101 with placebo. CAL101 is a monoclonal antibody that works by inhibiting the action of a protein, S100A4, which contributes to scar tissue formation. Therefore, CAL101 may slow down or stop the formation of new scar tissue on the lungs.
Approximately 150 patients will take part in this study at approximately 50 study sites across 10-12 countries.
Participants duration in this study will last approximately 40 weeks, consisting of a 24-week Treatment period and a 16-week Follow-up period.
All research studies have the potential for risks that are not yet known. In a previous study with CAL101 the only side effect reported that was suspected to be related to CAL101 was a mild reaction to the drug infusion. In addition to this, other possible side effects include the development of anti-drug antibodies and infection as well as possible side effects/discomforts from study procedures.
Participants may or may not benefit as a result of their participation in this study. However, results from this study may benefit others in the future, as the information collected may help patients with the same disease get better care in future years.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
25/ES/0012
Date of REC Opinion
3 Mar 2025
REC opinion
Further Information Favourable Opinion