Weldon Spring

Researchers are studying adults with moderate to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.

Researchers are evaluating the effectiveness and safety of rimegepant for intermittent prevention of menstrual migraine in women who experience migraine attacks related to their menstrual cycles. This Phase 3, double-blind, randomized study focuses on women aged 18 to 45 years with a history of menstrual migraine. The study is sponsored by Pfizer and aims to compare rimegepant with placebo in reducing migraine days during the perimenstrual period. Participants will be assigned to receive either rimegepant 75 mg orally disintegrating tablets (ODT) for 7 consecutive days during the perimenstrual period or a matching placebo for the same duration. Additionally, rimegepant may be used for acute migraine treatment as needed, alongside a standard of care option for acute treatment. The study includes a 5-month double-blind treatment phase covering five menstrual cycles. During the study, participants will be monitored for changes in the number of migraine days and headache days during the 5-day perimenstrual period, as well as changes in the use of acute migraine medications. Assessments will also include migraine severity and functional disability, cognitive effects, and monthly migraine and headache days normalized to 28-day cycles. Safety and efficacy will be tracked throughout the study, which is expected to last through March 2027.

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, for preventing recurrence of Clostridioides difficile infection (CDI). This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess the safety and rate of CDI recurrence eight weeks after treatment. The study includes participants with either recurrent CDI or primary CDI at high risk of recurrence, comparing VE303 to a placebo. Participants receive either VE303 or placebo capsules three times daily for 14 days, following 10 to 21 days of standard antibiotic treatment for CDI. VE303 capsules contain the active live bacteria, while placebo capsules contain inactive ingredients and look identical. The study is divided into two stages focusing on recurrent CDI and high-risk primary CDI populations. During the trial, participants are monitored for CDI recurrence over eight weeks, with assessments including stool sample testing and symptom tracking. The study evaluates the effectiveness of VE303 in preventing CDI from returning after initial antibiotic treatment, while monitoring participant safety. Total participation time includes the treatment period plus follow-up to week 8.