In short
Clinical trials are studying Vixarelimab in people with idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and moderate to severe ulcerative colitis. These trials are looking at how well it works, how safe it is, and other research measures such as lung function, remission, and drug handling in the body.
Key points
- Clinical trials of Vixarelimab are studying two main areas: lung disease and ulcerative colitis. One Phase 2 trial looked at idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease, while another Phase 2 trial studied moderate to severe ulcerative colitis. The lung study focused on change in forced vital capacity, a measure of lung function, after 52 weeks. The ulcerative colitis study focused on clinical remission at Week 12, using the modified Mayo Score. Both studies were interventional and are listed as completed.
Trial overview
Clinical trials of Vixarelimab in the source data are studying people with lung disease and ulcerative colitis. Both studies are Phase 2 and both are marked as completed.
Lung disease study
One completed trial studied Vixarelimab in patients with idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease. This was an interventional study, which means participants received a study treatment or placebo so results could be compared.
The study compared Vixarelimab with placebo in 330 participants. Its brief purpose was to evaluate efficacy and safety for each cohort, meaning each patient group was studied separately.
Ulcerative colitis study
Another completed Phase 2 trial studied Vixarelimab in participants with moderate to severe ulcerative colitis. The study was also interventional and included 260 participants.
This trial compared Vixarelimab with placebo and also listed several other medicines in the source data, showing that the study was set up to evaluate treatment options in this disease area. The brief summary says the trial aimed to evaluate efficacy in the induction of clinical remission at Week 12.
Trial design and participants
Both studies were designed for patients with a specific disease group, not for healthy volunteers. In the lung trial, the target groups were people with fibrotic lung disease, which means scarring in the lungs.
In the bowel trial, the target group was people with moderate to severe ulcerative colitis, which means the disease was active enough to need careful treatment study. The source data do not give detailed inclusion or exclusion rules, so only the disease groups can be confirmed here.
Outcomes measured
The main outcome in the lung disease trial was the absolute change from baseline to Week 52 in FVC, or forced vital capacity. FVC is the amount of air a person can breathe out after taking a deep breath, so it helps show how well the lungs are working.
The main outcome in the ulcerative colitis trial was clinical remission at Week 12. In this study, remission was defined by the modified Mayo Score, with low scores showing less disease activity and less bleeding, fewer bowel symptoms, and less inflammation seen on endoscopy.
The ulcerative colitis trial also included pharmacokinetics, which means how the body handles the study drug over time. This helps researchers understand exposure to the treatment during the study.