In short
Frevecitinib is an investigational inhaled medicine being studied for severe asthma that is not adequately controlled with standard therapy. It is currently in Phase 2 clinical development, with one authorised trial planning to enroll 798 participants. The trial measures lung function change after 12 weeks of treatment.
Key points
- Frevecitinib is an investigational inhaled therapy for severe asthma.
- The registered trial is in Phase 2 and is currently authorised.
- The trial plans to enroll 798 participants with severe asthma.
- The main measure is change in lung function (FEV1) from baseline to week 12.
- Three different doses of frevecitinib are being tested against placebo.
What is frevecitinib?
Frevecitinib is an investigational substance being developed as an inhaled therapy. In the EU Clinical Trials Information System (CTIS), it appears under the development code KN-002 as the active substance in an inhalation powder. The registered trial record describes it as a drug product for inhalation, and the trial also includes a placebo inhalation powder containing only excipients. Frevecitinib is not described in these records as an authorised medicine; it is still in clinical development.
How does frevecitinib work?
The registry data provided does not state the molecular target or mechanism of action of frevecitinib. The trial record describes only that the study aims to evaluate the clinical efficacy of frevecitinib in severe asthma. No supplementary sources describing how the substance works at a molecular level were provided.
Which conditions is frevecitinib studied for?
The registered clinical trial investigates frevecitinib in one condition:
- Severe asthma — specifically in patients whose asthma is not adequately controlled with medium to high dose inhaled corticosteroid plus long-acting beta-agonist (ICS/LABA) therapy.
How is frevecitinib given?
Frevecitinib is given by inhalation. The trial record lists the investigational product as an inhalation powder, and the placebo arm is described as a placebo inhalation powder. The trial also includes salbutamol given by inhalation; salbutamol is a separate medicine used as a reliever in asthma and is not the substance under investigation.
What do the clinical trials show?
One trial is registered in CTIS for frevecitinib. It is a Phase 2 interventional study that is currently authorised. The trial plans to enroll 798 participants with severe asthma not adequately controlled on medium to high dose ICS/LABA therapy. Three doses of frevecitinib are being evaluated, and the trial includes a placebo arm for comparison.
The primary outcome measure is the change in predose (pre-bronchodilator) forced expiratory volume in one second (FEV1) in litres from baseline to Week 12. FEV1 is a standard measure of lung function that shows how much air a person can forcefully exhale in one second.
What side effects are known?
No side effect information was provided in the registry data or in supplementary sources for this page. The authorised trial is designed to evaluate both efficacy and safety, but results are not yet available in the provided records.