Ludwigshafen Am Rhein

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates the effectiveness of upadacitinib (RINVOQ), an approved treatment for UC, in adults with active moderate to severe UC. The study aims to understand the early therapeutic response and predict the long-term effectiveness of this medication. Upadacitinib will be given according to the approved local label and prescribed by the participant's physician as part of routine care. About 400 adult participants from Germany, Austria, and Switzerland who are starting upadacitinib treatment will be enrolled. Treatment decisions are made by the investigator independently of the study. Participants will be followed for up to two years, with no extra procedures beyond their standard care. During the study, participants will attend regular hospital or clinic visits where routine data will be collected and used for the study. Researchers will monitor the percentage of participants achieving symptomatic remission based on clinical response and intestinal ultrasound at week 8, with follow-up assessments at week 52. The study focuses on real-world treatment outcomes without adding extra burden to participants.

Follicular lymphoma (FL) is the second most common B-cell cancer and the most frequent cancer of lymphocytes, but it is incurable with standard treatments and often returns. This research is a Phase 3 trial evaluating the safety and effectiveness of the investigational drug epcoritamab combined with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in adults who have not been treated for FL before. The study aims to assess adverse events and changes in disease activity among about 1095 participants worldwide. Participants are assigned to one of five treatment groups receiving different therapies. Treatments include R2 alone or combined with subcutaneous epcoritamab injections. Some may receive chemoimmunotherapy options chosen by investigators, including R-CHOP, G-CHOP, R-Benda, or G-Benda, involving various intravenous infusions and oral tablets. Most treatment arms last 120 weeks, except one lasting 24 weeks. The study treatments involve intravenous infusions, oral capsules or tablets, and subcutaneous injections. During the study, participants regularly visit hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will track responses such as complete response rates at 30 months and progression-free survival up to 10 years. The study also monitors safety and tolerability throughout. Participants’ treatment adherence and disease status will be carefully observed over the study period.

Researchers are evaluating targeted therapies for adult participants with moderate to severe Crohn's disease, a chronic condition causing severe inflammation in the digestive tract. This disease often leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. The study aims to assess the effectiveness and side effects of several targeted treatments, as current therapies may not work equally well for all patients or may lose effectiveness over time. This is a Phase 2a multicenter, randomized platform study enrolling around 540 adults across approximately 300 sites worldwide. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These therapies are administered either as injections under the skin or infusions into the vein, depending on the drug. Participants will be randomly assigned to one of the treatment groups. The study will involve regular visits to hospitals or clinics where participants receive their assigned treatments and are monitored throughout the study period. Participants will undergo medical assessments including blood tests and endoscopies to check the status of their disease and to monitor for any side effects. They will also complete questionnaires and keep a daily diary to track their condition. The main outcome measured is the percentage of participants who achieve endoscopic remission by week 12. The study involves careful safety monitoring and aims to provide detailed data on the treatments over the course of the trial.

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.