Tubingen

Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drugs safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.

Researchers are evaluating litifilimab BIIB059, a monoclonal antibody, in adults with active cutaneous lupus erythematosus CLE. This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus SLE, who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after previous therapy. This study compares the effects of two oral drug combinations belzutifan plus zanzalintinib versus cabozantinib. The aim is to find out if the combination of belzutifan and zanzalintinib helps patients live longer overall and delays cancer progression compared to cabozantinib alone. Participants in this study will be randomly assigned to one of two groups. One group will take belzutifan and zanzalintinib orally once daily, while the other group will take cabozantinib orally once daily. Treatment will continue until certain conditions require stopping. This is an open-label, phase 3 trial evaluating these treatments in people with advanced RCC who have had disease recurrence during or after prior anti-PD-1L1 therapy. During the study, participants will be monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also track response rates, duration of response, side effects, and quality of life using questionnaires over about 25 months. Safety assessments and regular evaluations will be performed as part of the study. Total study participation may last several years, depending on individual circumstances and treatment continuation.

Researchers are investigating treatments for oligodendrogliomas, a type of brain tumor classified by specific genetic markers including mutations in isocitrate dehydrogenase IDH and co-deletion of chromosomes 1p19q. This trial focuses on adults with newly diagnosed grade 2 or 3 gliomas, aiming to improve survival without loss of brain function, cognition, or quality of life. The study compares two treatment approaches to determine the best timing and combination of chemotherapy and radiotherapy. Participants are randomly assigned to receive either standard chemoradiation with procarbazine, CCNU lomustine, and vincristine PCV combined with radiotherapy, or an experimental approach starting with chemotherapy using lomustine and temozolomide CETEG followed by radiotherapy and PCV at tumor progression. Radiotherapy is delivered over about 5 to 6 weeks, with doses adjusted for tumor grade. Chemotherapy cycles last 6 weeks and include specified doses of oral and intravenous drugs. During the study, participants undergo regular magnetic resonance imaging MRI scans every three months, neurological assessments, quality of life questionnaires, and cognitive testing annually. The main outcome measured is qualified overall survival, which tracks survival without significant cognitive or functional decline. The study lasts up to 10 years, with ongoing monitoring of tumor progression, treatment response, and patient wellbeing. Safety and side effects are carefully assessed throughout the trial.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes BNT326 when used alone or combined with other immunotherapy drugs in adults with advanced solid tumors. These tumors are either metastatic, recurrent without further treatment options, or have relapsed after previous therapy. The study includes patients with different types of advanced cancers such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. In Part 1, participants receive BNT326 alone across several cancer-specific groups, including cutaneous melanoma, non-small cell lung cancer with or without specific mutations, rare melanomas, advanced tumors, and cervical cancer. Part 2 evaluates BNT326 alone or combined with another immunotherapy drug called pumitamig. Participants are assigned to different dose levels, sometimes randomly, depending on their cancer type and group. The study includes a screening period, treatment for up to 24 months or until progression or other reasons, and follow-up periods. During the study, participants undergo assessments including tumor tissue sampling, monitoring of treatment side effects, blood tests to measure drug levels, and evaluations of tumor response and survival. Safety is closely followed up to 42 or 90 days after treatment ends, with longer-term monitoring for up to 38 months Part 1 or 48 months Part 2. Participants overall response rates, adverse events, and pharmacokinetics are key outcomes. The study is sponsored by BioNTech SE and includes open-label, adaptive design across two phases.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC that tests positive for human papillomavirus 16 HPV16 and expresses the protein PD-L1. This Phase IIIII trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

Researchers are comparing two psychotherapy programs, the Cognitive Behavioral Analysis System of Psychotherapy CBASP and Behavioral Activation BA, in adults with persistent depressive disorder PDD who have not responded well to previous treatments. This study focuses on hospitalized patients with treatment-resistant depression and aims to evaluate which therapy is more effective in reducing depressive symptoms over 16 weeks. The study also explores factors that affect treatment response and the long-term effects of these therapies. Participants will receive either CBASP or BA treatment during a 10-week acute phase consisting of inpatient or dayclinic therapy followed by a 6-week outpatient continuation phase with group therapy. Both therapies include individual and group sessions, nurse contacts, and exercise therapy during inpatient treatment. All patients will also receive optimized antidepressant medication according to standard guidelines, with adjustments if needed based on response. During the study, participants will undergo regular assessments using various depression rating scales, symptom inventories, and quality of life questionnaires from baseline through 64 weeks after treatment start. Researchers will monitor responses, remission, relapse rates, and cost-effectiveness of the treatments. The total study duration includes acute treatment, continuation therapy, and long-term follow-up to evaluate sustained outcomes and health economic impacts.

Researchers are evaluating the retention rates of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA in a real-world setting in Germany. This observational study aims to compare how long patients stay on each treatment when prescribed according to local standards and labels. About 678 participants will be enrolled over approximately 24 months, with total study duration lasting up to 48 months. Participants will receive either upadacitinib or a TNFi treatment as prescribed by their physicians following local regulatory and reimbursement guidelines. The decision to treat with UPA or TNFi is made independently of the study and before recruitment. The study does not assign treatments but observes patients already prescribed these therapies. During the study, researchers will monitor participants for up to 24 months to measure retention rates of the treatments. Data collection will include regular assessments according to routine care practices to track treatment persistence. The study focuses on real-world outcomes without altering standard treatment or care. Safety monitoring and follow-up will be conducted as part of usual medical care.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

Researchers are evaluating the effectiveness and safety of volrustomig compared to observation in adults with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not shown disease progression after receiving definitive concurrent chemoradiotherapy cCRT. This phase III global study focuses on patients with specific stages of LA-HNSCC and aims to better understand treatment options after initial therapy. Participants are randomly assigned to one of two groups one group receives volrustomig, a drug being studied, while the other group is placed under observation without additional treatment. The study is open-label and conducted at multiple centers worldwide. The treatment or observation period follows the completion of definitive cCRT with curative intent. During the study, participants undergo regular assessments to monitor progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also track the presence of anti-drug antibodies and measure drug concentrations in blood samples. Safety is monitored by recording adverse events over a period of up to approximately 8 years, allowing long-term evaluation of outcomes and participant well-being.