Plymouth

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Researchers are evaluating the effect of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults aged 18 to 65 with moderate to severe ulcerative colitis who have not responded adequately to certain prior treatments. This phase 4 study focuses on clinical remission rates and treatment response in this population, aiming to understand the benefits of dual targeted therapy followed by vedolizumab alone. All participants first receive vedolizumab 300 mg via IV infusion at Weeks 0, 2, and 6 plus tofacitinib 10 mg tablets twice daily from Week 0 to Week 8. Those who respond clinically at Week 8 continue with vedolizumab 300 mg IV every 8 weeks alone through Week 46. The study lasts up to 76 weeks including treatment and follow-up. Participants undergo clinical assessments including Mayo score evaluations at multiple timepoints to measure remission and response. Safety is monitored through adverse event tracking and laboratory tests up to 26 weeks after the last vedolizumab dose. Patient questionnaires on quality of life and fatigue are also collected, with total participation extending over a year.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Adolescents in residential substance use treatment often face serious substance-related challenges and high relapse rates, with studies showing that 60% relapse within 90 days after discharge. Parenting practices play a key role in influencing adolescent substance use outcomes, yet engaging parents in treatment has historically been difficult. This research evaluates a technology-assisted parenting program called Parent SMART, designed to support parents and improve adolescent outcomes during and after residential treatment. Parent SMART combines an existing computer-based parenting skills program called Parenting Wisely with up to four telehealth coaching sessions and an app-based networking forum where parents can connect with experts and other parents. The study compares adolescents receiving standard residential treatment alone to those whose parents receive Parent SMART alongside usual care. Parent SMART sessions are delivered by counselors, and the program is offered both during short and long residential stays, with the goal of enhancing parental monitoring and communication. Participants include adolescent-parent pairs who will be randomly assigned to either standard treatment or Parent SMART plus treatment. Follow-up assessments occur at 6, 12, and 24 weeks after discharge, including self-reports, videotaped interactions, and urine screenings. The study measures changes in parenting behaviors, adolescent substance use, and related high-risk behaviors over 24 weeks. The results aim to show whether Parent SMART improves parenting and reduces adolescent substance use and related problems after residential treatment.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of a modified dosing schedule of ublituximab for adults with relapsing multiple sclerosis RMS. This phase 3b study has three parts Part A is an open-label single-arm study, Part B is a randomized, double-blind, placebo-controlled study, and Part C is an open-label single-arm study focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The primary goal is to measure changes in T1 Gadolinium-enhancing brain lesions and drug levels in the blood. Participants receive ublituximab by intravenous infusion following different dosing regimens depending on the study part. In Part A, participants initially received infusions on Day 1 of Week 1, Day 15 if applicable, and Week 24. In Part B, participants receive either 600 mg ublituximab on Week 1 Day 1 followed by placebo on Day 15 and 450 mg ublituximab at Week 24, or 150 mg ublituximab on Day 1 followed by 450 mg on Day 15 and Week 24. Part C participants receive 150 mg on Day 1, then 450 mg on Day 15 and Week 24. Enrollment in Parts A and B has closed according to protocol updates. During the study, participants undergo regular assessments including brain imaging to track T1 Gadolinium-enhancing lesions, blood tests to measure drug levels, and evaluations for infusion-related reactions. Treatment satisfaction questionnaires are collected at baseline, Week 24, and Week 48. Safety and efficacy are monitored up to 48 weeks. The total study duration covers treatment and follow-up visits, with primary outcomes measured at Week 48 to assess changes from baseline.

Researchers are evaluating the safety and remyelinating effects of the SetPoint System, a miniaturized nerve stimulator implanted in the neck, in adults with relapsing-remitting multiple sclerosis RRMS. This pilot study involves up to 60 participants who continue their standard disease-modifying therapies while using the device. The study aims to understand how this device, used alongside standard care, might support myelin repair in RRMS patients. Participants will undergo surgery to implant the device on the left vagus nerve under general anesthesia. They will be randomly assigned so that two-thirds receive active stimulation and one-third receive non-active sham stimulation daily for one minute over 48 weeks. After the first 48 weeks, control group participants will crossover to active stimulation, and all participants will be followed openly for an additional 48 weeks to observe long-term safety. During the study, participants will be monitored for adverse events from consent through 96 weeks. They will have regular assessments during the treatment and follow-up periods to evaluate safety and device effects. The study includes evaluations such as visual evoked potentials, retinal imaging, and neurological disability scoring to track disease status and response to the intervention.

Researchers are evaluating the use of a non-invasive cryo-compression therapy to improve pain control after arthroscopic rotator cuff surgery. This study compares this novel method to standard ice wraps in managing post-operative pain, swelling, opioid use, and quality of life. The trial aims to provide evidence that could influence pain management practices in orthopedic surgery, addressing concerns about opioid use. Participants are randomly assigned to one of two groups one using the intermittent cryo-compression device called the NICE Recovery SystemTM, and the other using standard gel ice packs with wraps. The cryo-compression group receives a compression sleeve applied immediately after surgery with programmed compression and cooling settings, aiming for at least 6 hours of treatment daily. The control group uses gel ice packs with the same daily duration. Both groups follow a detailed post-operative care plan. Participants will complete pre-operative data collection and maintain a diary to record pain and therapy use until the first post-operative visit. Follow-up visits are scheduled at 2 days, 1 visit shortly after, 60 days, 3 months, 6 months, and 12 months post-surgery. Researchers will assess pain using the Visual Analog Scale, measure arm swelling, analyze costs, and evaluate quality of life over one year. This thorough monitoring aims to capture differences in recovery and patient experience between the two cryotherapy methods.

Researchers are studying VE303, a live biotherapeutic product made of nonpathogenic bacteria strains, to evaluate its safety and effectiveness in preventing recurrent Clostridioides difficile infection CDI. This Phase 3 trial compares VE303 to a placebo in participants who recently completed standard antibiotic treatment for CDI. The study focuses on two groups those with recurrent CDI and individuals at high risk for primary CDI recurrence. Participants will receive either VE303 or a matching placebo capsule three times daily for 14 days, following 10 to 21 days of standard antibiotic therapy for CDI. VE303 capsules contain the study bacteria, while placebo capsules contain a non-active substance identical in appearance. Both groups complete this treatment regimen as part of the trial. During the study, participants are monitored for safety and CDI recurrence up to 8 weeks after treatment starts. Researchers collect stool samples and track symptoms to assess recurrence rates. The study uses a randomized, double-blind design to ensure unbiased results, and participants are followed closely through the treatment and observation periods, which last several weeks.