Greenville

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are evaluating a new vaccine called V118C designed to help prevent pneumococcal disease, an infection caused by Streptococcus pneumoniae bacteria. This clinical trial focuses on infants and toddlers to assess how safe and well-tolerated V118C is in young children. The study is a Phase 1, randomized, double-blind trial comparing V118C with an existing vaccine called PCV20. The study is divided into two stages. Stage 1 involves toddlers aged 12 to 15 months who have already received a primary series of three doses of PCV vaccine they will receive a single dose of either V118C or PCV20. Stage 2 includes infants starting at approximately 2 months old who will receive four doses three infant doses plus one toddler dose of either V118C or PCV20. All doses are given as 0.5 mL intramuscular injections. Participants will be monitored closely for adverse events immediately after vaccination, as well as for up to 12 months postvaccination. Researchers will collect blood samples to measure immune responses to the vaccines. They will track both injection site and systemic reactions, serious adverse events, and medically attended events. The study aims to understand both safety and immune response profiles of V118C compared to PCV20 over the course of the dosing schedules and follow-up periods.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

This research aims to evaluate the long-term safety and effectiveness of liquid abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. The study is a Phase 3, open-label trial enrolling approximately 500 participants globally, including those who have previously completed abrocitinib studies and those new to this treatment. The study duration extends up to 2 years or until the medicine becomes commercially available, whichever comes first. Participants will receive abrocitinib oral suspension throughout the study. The trial enrolls two groups an extension cohort of children aged 2 to under 12 years who have completed prior abrocitinib studies, and a de novo cohort of children aged 6 to under 12 years who have not been in previous abrocitinib trials. Both groups may use topical medications alongside the study drug as needed. During the study, participants will be regularly assessed for safety by monitoring adverse events, laboratory abnormalities, and other health measures. Researchers will evaluate skin condition improvements using various scales such as the Validated Investigators Global Assessment vIGA, Worst Itch Numerical Rating Scale WI-NRS, and Eczema Area and Severity Index EASI. Quality of life and other patient-reported outcomes will also be tracked. The study includes follow-up to track treatment effects and safety over the full 24 months.

This research focuses on adults with obesity or overweight and aims to evaluate the safety and effectiveness of various investigational treatments for chronic weight management. It is a Phase 2 master protocol study that uses a framework to test multiple interventions, each detailed in separate appendices. The study establishes criteria for enrolling new participants and reports results when all intervention appendices have completed. Participants may receive different investigational drugs administered either by subcutaneous injection or orally, including LY3305677, LY3841136, tirzepatide, LY3549492, and others. Each intervention-specific appendix outlines the particular treatment details and analyses. Some participants receive placebos matching the administration method of the active treatments. Treatments and analyses are conducted in parallel groups, and interventions may start independently as they become available. Throughout the study, participants undergo screening to confirm eligibility and are randomly assigned to one of the intervention groups or placebo. Researchers monitor participant allocation up to week 6. The trial emphasizes double-blind procedures, and participant involvement includes receiving study treatments and attending scheduled visits. Safety and efficacy data are collected, and the study is planned to continue until early 2028, with primary outcome measures focusing on participant allocation to interventions.

Researchers are evaluating the effectiveness of a peer recovery coaching intervention called RC-Link for patients hospitalized due to medical complications from Alcohol Use Disorder AUD. This study aims to improve recovery outcomes by reducing heavy drinking, enhancing biopsychosocial functioning, and achieving remission from AUD, guided by the new NIAAA definition of recovery. The study will also explore mechanisms behind heavy drinking using daily ecological momentary assessment EMA and assess the cost-effectiveness of the RC-Link program through a randomized controlled trial design. The trial compares two groups one receiving bedside peer recovery coaching initiated during hospitalization plus six months of ongoing support, and a control group receiving a brief intervention, usual care with a referral list, and follow-up contact after the study period. The RC-Link program involves personalized recovery planning with a peer coach and regular contact at least twice a week via phone, virtual, or in-person meetings, using a standardized coaching checklist to provide socioemotional, instrumental, and informational support. Participants will be assessed at baseline, monthly during the six-month intervention, and six months after intervention completion. Evaluations include heavy drinking frequency, remission status based on DSM-5 criteria, biopsychosocial functioning, cost-effectiveness, coping, treatment and social support engagement, hospital utilization, breath alcohol content levels, and craving changes. This comprehensive monitoring aims to understand how peer recovery coaching affects long-term recovery outcomes for hospitalized AUD patients.

Researchers are conducting a Phase 1, open-label study to evaluate CTX-10726 monotherapy in adults with metastatic or locally advanced cancers that are relapsed or refractory to standard treatments, or when no effective standard therapy exists. This first-in-human trial aims to assess the safety, tolerability, immune response, and how the body processes CTX-10726, while also observing preliminary anti-tumor effects. The study is sponsored by Compass Therapeutics and focuses on cancers including renal cell carcinoma, hepatocellular carcinoma, gastroesophageal cancer, and endometrial cancer. Participants will receive CTX-10726 through intravenous infusions given every two weeks. The study is divided into two parts a Dose Escalation Cohort where doses range from 0.3 to 10.0 mgkg to determine safe and tolerable levels, followed by a Dose Expansion Cohort that uses doses selected from the escalation phase. Treatments continue in cycles of two weeks, with infusions administered repeatedly based on the study design and patient response. Throughout the trial, participants will undergo safety monitoring for side effects, assessments of immune response, and tests measuring drug levels in the blood. Tumor responses will be evaluated using standard criteria, and disease progression and survival will be tracked for up to two years. Organ function tests, imaging, and other health evaluations will be performed regularly. Participants are followed closely to monitor treatment effects and safety from the first dose until after treatment ends.

Researchers are evaluating KK2430, an experimental intravenous drug, as a potential treatment for people with Hematologic Neoplasms. This Phase 12 study aims to understand whether KK2430 is safe, how the body processes it, and whether it shows any effects in treating this condition. KK2430 has not been previously approved by health authorities, and this study marks its first use in humans. Participants will receive KK2430 through intravenous administration, with some possibly receiving a placebo as part of the study design. The study is conducted in a sequential manner, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. The study includes a treatment period lasting an average of three months, during which various assessments will be made. Throughout the study, participants will undergo multiple evaluations including dose level toxicity checks 28 days after the first dose and monitoring of adverse events for about 1.5 years. Other assessments during treatment include pregnancy tests, ECG measurements of QT and QRS intervals, and vital sign monitoring. Participants will be followed from screening through study completion to collect safety and effectiveness data, with the total study period lasting until around October 2027.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.