Wesseling

Researchers are studying the effects of etrasimod as a treatment for adults with moderate to severe ulcerative colitis. The study aims to understand how etrasimod works in real-world medical practice for patients aged 18 to 64 who have not taken this medication before. Patients will be treated according to standard medical care, with etrasimod chosen as the best treatment option by their physician. All participants will receive etrasimod as prescribed in routine care. The study lasts for 52 weeks, followed by a 28-day safety follow-up. During this time, patients will visit their doctors as usual and complete health questionnaires on their own mobile phone, tablet, or computer at regular intervals. These questionnaires will help track their health and treatment effects. Participants will be assessed by comparing their disease activity before starting etrasimod to their progress during treatment. Data collected includes patient-reported outcomes via online questionnaires and clinical assessments done during regular doctor visits. The main outcomes measured are the proportion of patients who achieve symptom remission at 12 weeks and 52 weeks.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This research aims to assess how treatment with risankizumab affects disease activity in adults with moderate to severe UC in real-world clinical settings. Risankizumab is an approved medication for UC, and the study will enroll about 200 adult participants across multiple sites in Germany and Austria. Participants will receive risankizumab as prescribed by their own doctors following routine clinical practice and according to local guidelines. There are no additional treatments or interventions beyond normal care. The study will follow participants for up to 52 weeks to observe changes in their disease activity while on this medication. During the study, participants will attend regular visits at hospitals or clinics as usual for their condition. Researchers will monitor the percentage of participants achieving symptomatic remission based on a standard scoring system over approximately one year. No extra burden beyond routine clinical visits is expected for participants throughout the study.