Plymouth

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Researchers are evaluating the effects of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults who have moderate to severe ulcerative colitis (UC) and have not responded well to or tolerated up to two previous tumor necrosis factor (TNF) antagonist treatments. This Phase 4, open-label study focuses on the clinical remission achieved with this dual targeted therapy. The study includes about 65 participants and is being conducted at multiple centers in the United States and Canada. All participants will receive vedolizumab 300 mg intravenously together with tofacitinib 10 mg orally for the first 8 weeks. Those who respond to this combined treatment at Week 8 will then continue with vedolizumab alone for an additional 44 weeks. The total study duration for each participant can be up to 76 weeks, including a follow-up period of 26 weeks after the last dose of vedolizumab to monitor safety. During the study, participants will be regularly assessed for clinical response using the complete Mayo score at Week 8. The researchers will also monitor safety and remission status throughout the treatment and follow-up periods. Participants will undergo endoscopic evaluations, clinical exams, and laboratory tests to track their ulcerative colitis activity and response to the therapies.

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

Adolescents undergoing residential treatment for substance use face high risks of relapse, with 60% returning to substance use within the first 90 days after discharge. Parenting practices strongly influence these outcomes, but engaging parents in treatment is challenging. This research evaluates Parent SMART, a technology-assisted parenting program designed to support parents of adolescents in residential substance use treatment by improving parenting skills and reducing adolescent substance use and related high-risk behaviors. The Parent SMART intervention combines an existing computer program called Parenting Wisely with four telehealth coaching sessions and a mobile networking forum where parents can interact with experts and other parents. This program is tested alongside standard residential treatment by randomly assigning adolescent-parent pairs either to receive usual care alone or with the added Parent SMART support. Telehealth coaching is provided by trained counselors, and parents in the usual care group are offered access to the Parent SMART technology after six months. Participants include adolescents aged 12 to 18 admitted for substance use concerns and their primary guardians. Assessments occur before discharge and at 6, 12, and 24 weeks after leaving treatment, including self-reports, videotaped interactions, and urine tests. Researchers measure changes in parental monitoring and communication, adolescent substance use frequency and problems, and high-risk behaviors such as school and legal issues. The study also explores if improved parenting drives positive changes in adolescent outcomes, aiming to enhance long-term recovery support through scalable technology.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.

Researchers are evaluating a modified regimen of ublituximab in adults with relapsing multiple sclerosis (RMS) to assess its effectiveness and safety. The study is a phase 3b trial consisting of three parts: Part A is open-label and single-arm, Part B is randomized, double-blind, and placebo-controlled, and Part C is open-label focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The main goal is to measure changes in T1 Gadolinium-enhancing lesions in the brain to see how well the treatment works. Participants receive ublituximab or placebo through intravenous (IV) infusions during different parts of the study. Part A and Part C involve ublituximab infusions, while Part B compares ublituximab to placebo infusions. Part C includes participants who have been treated with an anti-CD20 agent for at least six months but had suboptimal results and meet specific washout requirements before beginning this study. During the study, participants undergo regular assessments, including brain MRI scans to monitor T1 Gd-enhancing lesions over 48 weeks and pharmacokinetic measurements up to 16 weeks. Researchers also evaluate safety and treatment responses throughout the study. The trial includes adults aged 18 to 65 with stable neurological status and a disability score of 5.5 or less. Female participants of childbearing potential must use contraception during and after the study. Total participation time varies based on the study part and treatment schedule.

Researchers are evaluating the safety and remyelinating effects of the SetPoint System in adults diagnosed with relapsing-remitting multiple sclerosis (RRMS). This pilot study involves up to 60 participants across 10 sites in the U.S. The SetPoint System is designed to be used alongside standard therapies for RRMS and includes a miniaturized stimulator implanted on the vagus nerve in the neck. The study aims to assess the device's effects on nerve repair and safety over time.

Researchers are evaluating the use of a non-invasive cryo-compression therapy compared to standard ice wraps for managing pain after arthroscopic rotator cuff repair surgery. This randomized controlled study aims to improve post-operative pain control while reducing reliance on opioid medications. The study also looks at effects on tissue swelling, patient quality of life, and the cost-effectiveness of cryo-compression compared to other pain management methods. Participants will be randomly assigned to receive either the intermittent cryo-compression therapy using the NICE Recovery SystemTM or traditional gel ice packs and wraps immediately after surgery. Both groups will be instructed to use their assigned cold therapy for about 6 hours daily following surgery. The study plans to enroll 100 patients, with half receiving cryo-compression and half receiving standard ice therapy. During the study, participants will complete a pre-operative data collection and keep a diary to track post-operative pain and therapy usage. Follow-up visits will occur at 2 days, the first post-operative visit, 60 days, 3 months, 6 months, and 12 months after surgery. Researchers will measure pain levels using a visual analog scale (VAS), evaluate swelling by comparing arm measurements before and after surgery, and assess quality of life through patient reports. The study will monitor opioid use and overall safety throughout the post-operative period of up to 15 days and longer-term follow-up for one year.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, to prevent recurrent Clostridioides difficile infection (CDI). This randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the safety and CDI recurrence rate at 8 weeks in participants receiving a 14-day course of VE303 or a matching placebo. The study includes two stages: one focusing on participants with recurrent CDI and the other on those with primary CDI at high risk of recurrence. Participants will receive either VE303 or placebo capsules that look identical and contain no active drug. The treatment lasts for 14 days, starting on the last planned day of standard antibiotic therapy for the qualifying CDI episode or within 2 days after completing antibiotics. Participants must have completed and responded to standard antibiotic treatment before receiving study medication. The study evaluates the effect of VE303 versus placebo on preventing CDI recurrence after antibiotic therapy. During the study, participants will be monitored through clinical evaluations to track CDI recurrence by Week 8, including stool samples tested for CDI. Safety and clinical response will be assessed throughout the study period. Participants are followed to ensure stability after the qualifying CDI episode and to monitor any complications or adverse events. The total participation duration includes treatment and follow-up through Week 8 to measure CDI recurrence rates and safety.