The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

Type: Interventional

Start Date: Sep 2025

open study

This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.

Type: Interventional

Start Date: Dec 2025

open study

Researchers are looking for new ways to treat types of breast cancer that are both: - High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment - Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: - Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy - Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Type: Interventional

Start Date: Jun 2025

open study

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.

Type: Interventional

Start Date: Jun 2025

open study

AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.

Type: Interventional

Start Date: Aug 2025

open study

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: - Hepatoblastoma is a common liver cancer in babies and very young children - RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs - Relapsed means the cancer came back after treatment - Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: - About the safety of HER3-DXd in children and if they tolerate it - What happens to HER3-DXd in children's bodies over time - If children who receive HER3-DXd have the cancer get smaller or go away

Type: Interventional

Start Date: May 2025

open study

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Type: Interventional

Start Date: Jun 2025

open study

The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are: - Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)? - Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs? Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.

Type: Interventional

Start Date: Jul 2025

open study

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: - Participants will be screened to check if they can join the study. - Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. - Neither the researchers nor the participants will know what the participants will receive. - Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. - Afterwards, participants will enter a follow-up period which will last 80 weeks. - In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Type: Interventional

Start Date: May 2025

open study

This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.

Type: Interventional

Start Date: Jun 2025

open study

This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety.

Type: Interventional

Start Date: Sep 2025

open study

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Type: Interventional

Start Date: Nov 2025

open study

A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites

Type: Interventional

Start Date: Apr 2025

open study

This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Type: Interventional

Start Date: Apr 2025

open study

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Type: Interventional

Start Date: Sep 2025

open study

Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)

Type: Observational

Start Date: Sep 2025

open study

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).

Type: Interventional

Start Date: Apr 2025

open study

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Type: Interventional

Start Date: Mar 2025

open study

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Type: Interventional

Start Date: Apr 2025

open study

This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.

Type: Interventional

Start Date: Feb 2026

open study

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC. Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Type: Interventional

Start Date: Mar 2025

open study

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

Type: Interventional

Start Date: Feb 2025

open study

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Type: Interventional

Start Date: Jul 2025

open study

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Type: Interventional

Start Date: May 2025

open study

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Type: Interventional

Start Date: Feb 2026

open study