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Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are studying a new treatment for HIV-1 infection that combines two medicines, islatravir and ulonivirine, taken once weekly. The goal is to see if this new study treatment works as well as the standard antiretroviral therapy (ART), which usually involves taking up to three medicines once or twice daily. This research also aims to learn about the safety and tolerability of the study treatment compared to the standard ART. The study compares the once-weekly combination of islatravir and ulonivirine with the standard daily treatment of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants will take either the study drugs or the standard drugs for 96 weeks. Some participants may receive matching placebos as part of the study design. The treatment is given orally as capsules or tablets according to the assigned group. Participants will be monitored throughout the study with regular assessments, including measuring the amount of HIV-1 virus in the blood to see if it is suppressed below 50 copies/mL at weeks 24 and 48. The study will also track any side effects or adverse events and whether participants stop the treatment due to these events. Overall, the study lasts about 96 weeks, with ongoing safety and effectiveness evaluations to understand how well the treatments work and how safe they are over time.

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread from the cervix to other parts of the body. This Phase 3 study aims to evaluate the safety and effectiveness of combining sacituzumab tirumotecan (sac-TMT), an antibody drug that targets cancer cells, with pembrolizumab and bevacizumab. The study seeks to find out if this combination can help people live longer or keep their cancer from worsening compared to standard treatments. The study has two parts. In Part 1, participants receive sac-TMT together with pembrolizumab and bevacizumab to assess safety. In Part 2, after standard initial treatment, those whose cancer does not progress will be randomly assigned to maintenance treatment with either pembrolizumab alone or sac-TMT plus pembrolizumab. Bevacizumab may be added during maintenance treatment based on the doctor's decision. All treatments are given through intravenous infusions, and participants may receive rescue medications to manage side effects before sac-TMT infusion. Participants will be monitored for adverse events and treatment tolerability over several months. The study measures include progression-free survival and overall survival, assessed by independent review. Safety and treatment continuation rates are tracked during Part 1 for up to approximately 66-69 months, while Part 2 outcome measures extend up to 48-60 months. Various assessments, including laboratory tests and evaluations of cancer status, will be performed throughout the study to understand treatment effects and participant well-being.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.