Nowy Targ

Researchers are evaluating the safety and effectiveness of EscharEx (EX-03 5% formulation), a gel made from a sterile lyophilized powder containing proteolytic enzymes, compared to a placebo gel without enzymes. The study focuses on the treatment of Venous Leg Ulcers (VLU), which are wounds on the legs caused by poor venous blood flow. This Phase 3 trial will involve at least 216 adults with VLUs that range in size from 2 to 25 square centimeters and have lasted between 4 weeks and 12 months. Participants will be randomly assigned to receive either EscharEx or the placebo in a double-blinded setup, meaning neither patients nor researchers know which treatment is given. The study lasts up to 29 weeks and includes several stages: a screening period with two visits one week apart; a daily treatment phase with up to eight daily applications over two weeks to remove necrotic tissue; a weekly wound management period lasting up to 12 weeks with up to 13 visits, plus up to two weeks for confirming wound closure; and finally, a 12-week monthly follow-up with three visits to monitor wound closure durability. Throughout the study, researchers will visually assess the removal of dead tissue after each treatment application and monitor the time it takes for the wound to fully close. Patients will undergo standardized wound care and regular clinical evaluations, including measurements of the wound area. Safety and wound healing progress will be carefully tracked during all visits, ensuring comprehensive monitoring of treatment effects and wound status over the entire study duration.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effectiveness and safety of RO7837195 in adults with moderately to severely active ulcerative colitis who have not responded well or tolerated conventional or advanced treatments. This Phase IIb study aims to compare RO7837195 to a placebo during the initial treatment phase and then monitor all participants receiving the active drug to assess clinical remission at 12 weeks. The study includes a screening period lasting up to 5 weeks, followed by a 12-week induction phase where participants receive either RO7837195 or a matching placebo according to a specified schedule. After this induction phase, all participants enter a 40-week active treatment extension where they receive RO7837195 regardless of their earlier response. A safety follow-up period occurs after the last dose to continue monitoring participant health. Participants will undergo assessments throughout the study to measure clinical remission at week 12 and to monitor safety and pharmacokinetics. Researchers will collect data on symptoms, treatment effects, and any side effects experienced. The total participation involves multiple phases designed to carefully evaluate the long-term impact and safety of RO7837195 in ulcerative colitis management.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared to placebo in patients who recently experienced an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether FCM impacts mortality, heart failure events, serum NT-proBNP levels, and quality of life over a follow-up period of up to 36 months. The study specifically looks at the number and timing of heart failure events, changes in heart failure biomarkers, and quality of life using the EQ-5D questionnaire.

Researchers are evaluating the effectiveness and safety of obefazimod compared to a placebo in adults with moderately to severely active Crohn's Disease who have not responded well or are intolerant to conventional or advanced treatments. The study is a Phase 2b trial and includes three treatment phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. The main goals are to assess how well obefazimod controls disease activity and its safety over these periods. Participants will receive either obefazimod or a matching placebo once daily, preferably in the morning with food. The trial includes an initial 12-week treatment to induce response, followed by a 40-week maintenance period to sustain results. Those who complete these phases may enter a 48-week Extension Phase to further evaluate the long-term safety and tolerability of obefazimod compared to placebo. During the study, participants will undergo regular assessments including clinical evaluations of disease activity using the Crohn's Disease Activity Index and endoscopic scoring at various time points up to week 52. Safety is monitored throughout, especially during the Extension Phase with checks for adverse events, blood tests, and other laboratory evaluations at scheduled visits. Overall, participation may last over a year, with careful monitoring of treatment effects and safety.

Researchers are evaluating the effects of different electrical frequencies used in percutaneous electrical nerve stimulation (PENS) on muscle strength and pressure pain thresholds. PENS delivers electrical currents through fine needles inserted near nerves and has been explored for chronic pain in areas like the cervical and lumbar spine and limbs. Despite clinical use, evidence supporting PENS for chronic musculoskeletal pain is limited, especially for applications targeting nerve tissues in the upper limbs. Preliminary studies suggest PENS may reduce pain and disability by affecting both peripheral and central nervous system mechanisms, but more research is needed to understand its effects and optimal dosage. This study compares two PENS dosages applied under ultrasound guidance using sterile needles placed in the suprascapular and axillary nerves. One group receives high frequency stimulation at 100 Hz with pulses repeated five times in a pattern of 5 seconds on and 55 seconds off. The other group receives low frequency stimulation at 2 Hz for 10 minutes, with an intensity that causes visible motor responses but remains comfortable for participants. Both treatments involve a single session of PENS using the APSe4 electrostimulator. Participants will be assessed for muscle strength and pressure pain thresholds before and 10 minutes after the intervention. The study focuses on adults aged 18 to 65 with latent myofascial trigger points in the infraspinatus muscle. Researchers will measure changes in muscle strength and local pain sensitivity to evaluate the impact of different PENS frequencies. Safety and tolerability will also be monitored throughout the study.