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This research aims to assess the long-term safety and tolerability of JNJ-81201887, a medicine given by injection into the eye, in people with geographic atrophy secondary to age-related macular degeneration. The study includes participants who were previously treated in earlier clinical studies of this medicine. The main goal is to monitor any eye or systemic side effects and abnormal findings over up to five years. Participants who received low or high doses of JNJ-81201887 in earlier studies, as well as those initially given a sham procedure who may have later received the medicine, will join this extension study. No new treatments or injections will be given during this long-term study. It is designed as a randomized, triple-masked phase 2 trial to carefully observe participants over time. During the study, participants will have regular eye examinations, retinal imaging, and laboratory tests to check for any changes or adverse events related to the earlier treatment. Researchers will track ocular and systemic treatment-emergent adverse events for up to five years. Participants will be involved throughout this period with scheduled visits to monitor their condition and safety status consistently.

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease (CKD) and high blood pressure (hypertension). This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy (GA), a late stage of Age-related Macular Degeneration (AMD) that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups: one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are evaluating XB628, a new type of bispecific antibody natural killer (NK) cell engager designed to target NKG2A, an inhibitory receptor on NK cells, and PD-L1, in people with recurrent advanced or metastatic solid tumors. This phase 1, first-in-human trial aims to find the highest safe dose and the recommended dose for further study of XB628 as a single treatment. The study focuses on participants who have already received prior systemic anticancer therapy and have tumors not suitable for curative surgery or radiation. Participants will receive escalating doses of XB628 through intravenous infusions during the dose-escalation stage. The goal is to determine the maximum tolerated dose and recommended dosage(s) for expansion. The study is open-label, meaning both researchers and participants know the treatment being given. Participants will be closely monitored throughout the treatment period, which includes assessing their response to the drug and any side effects. During the study, participants will have regular evaluations including monitoring for dose-limiting toxicities and treatment-emergent adverse events over 21 days and up to 27 months. Blood samples will be collected to measure drug concentration and immune response. Researchers will also track how the drug is processed in the body and the overall tumor response. The total participation duration can be up to 27 months, during which safety and treatment effects will be carefully assessed.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition affecting the joints and skin in people with psoriasis. This study aims to understand how well the drug zasocitinib (TAK-279) works in adults with active PsA who have never been treated with biologic disease-modifying antirheumatic drugs. Participants will be involved in this Phase 3 trial to evaluate the drug's effects and safety. Participants will be randomly assigned to one of several groups receiving different treatments. Some will take zasocitinib Dose A or Dose B tablets once daily for up to 52 weeks. Others will receive an active comparator capsule twice daily for up to 52 weeks. A placebo group will take placebo once daily for 16 weeks, then switch to zasocitinib Dose A or B from Week 16 to Week 52. This design allows comparison between the new drug, an active treatment, and placebo. During the study, participants will have regular visits and assessments to monitor their joint and skin symptoms. Researchers will measure responses using criteria like the American College of Rheumatology 20 (ACR20) response at Week 16, among other disease activity and quality of life assessments. The study duration for each participant can last up to 60 weeks, including treatment and follow-up to evaluate the drug's impact and safety.

Researchers are evaluating the efficacy, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite taking antithyroid drugs. This phase 2b, randomized, double-blind, placebo-controlled study is conducted across multiple global centers to better understand treatment options for this condition. The study is led by Immunovant Sciences GmbH and focuses on adult patients aged 18 to 75 years. Participants will receive one of three study treatments for 26 weeks: IMVT-1402 at dose 1, IMVT-1402 at dose 2, or a placebo. Each participant is randomly assigned to one of these groups without knowing which treatment they receive, ensuring an unbiased assessment. The study aims to compare these treatments based on their ability to help participants become euthyroid and stop antithyroid drug use. During the study, participants will be closely monitored through regular visits where thyroid hormone levels, including triiodothyronine (T3) and free thyroxine (FT4), will be measured. The primary outcome is the percentage of participants who achieve normal thyroid function without antithyroid drugs by week 26. Secondary outcomes include additional hormone level measurements and seronegative status. Safety and tolerability are also assessed throughout the trial, which continues until May 2027.

Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder (MDD) who have already responded to treatment with AXS-05. This is a randomized, double-blind, active-controlled study conducted across multiple centers, aiming to assess relapse prevention in people diagnosed with MDD without psychotic features. Participants will first receive open-label AXS-05 treatment for up to 10 weeks, during which their response and remission will be monitored. Those who meet response and remission criteria will then be randomly assigned to continue taking AXS-05 or switch to bupropion tablets, both taken twice daily, for a double-blind treatment period lasting up to 26 weeks or until depressive symptoms relapse. Throughout the study, participants will be closely monitored for signs of depressive symptom relapse using regular assessments. The main outcome measured is the time from randomization to relapse over the 26-week double-blind period. The entire study period includes an initial 10-week treatment phase followed by up to 26 weeks of randomized treatment, with ongoing evaluation by the study team to track safety and treatment effects.

Researchers are evaluating the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to 17 years with moderate to severe plaque psoriasis. This is a randomized, double-blind, placebo-controlled Phase 3 study sponsored by Bristol-Myers Squibb. The study focuses on improving psoriasis symptoms and assessing overall treatment impact in this younger population. Participants will receive either Deucravacitinib or a placebo at specified doses on certain days. The study includes a treatment period of at least 16 weeks during which drug effects will be monitored closely. The trial measures improvements in psoriasis severity, body surface area affected, itch severity, and quality of life. Long-term safety and other health parameters will be followed for up to five years. During the study, participants will undergo regular assessments including clinical evaluations of psoriasis severity using the Psoriasis Area and Severity Index and the static Physicians Global Assessment. They will also complete questionnaires related to quality of life and itch symptoms. Blood tests will monitor drug levels and antibody protection to certain vaccines. Safety monitoring will include tracking adverse events, laboratory tests, physical exams, weight, height, and sexual maturation over several years.

Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile (C. difficile) infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.

This research aims to assess the long-term safety and tolerability of adjunctive KarXT in adults with schizophrenia who have not responded adequately to their current antipsychotic treatment. It is a Phase 3, multicenter, 52-week, open-label extension study involving participants who previously completed the treatment period of the ARISE Study (KAR-012). Participants will receive adjunctive KarXT, a combination of xanomeline and trospium chloride, taken twice daily at fixed doses. The study follows participants for up to 52 weeks to monitor the effects of this medication combination. This is an open-label study, meaning all participants receive the study treatment without placebo comparison. During the study, participants will undergo regular safety assessments to track any treatment-emergent adverse events. Researchers will monitor serious adverse events and those leading to discontinuation of the study drug. Participants must provide informed consent and have a reliable caregiver to assist with study activities throughout the trial. The total participation duration includes the treatment period and safety follow-up until week 54 or early termination.