Georgetown

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease (IBD). This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

Researchers are evaluating an investigational drug called ALN-HSD for adults with Metabolic Dysfunction-Associated SteatoHepatitis (MASH), a liver condition where fat buildup causes inflammation and scarring. The study aims to see how ALN-HSD affects liver scarring in MASH and explores how the drug works, its side effects, and how the body processes it. This is a phase 2, randomized, double-blind, placebo-controlled clinical trial focusing on participants with genetic risk factors for MASH. Participants will be randomly assigned to receive either ALN-HSD or a placebo in equal groups. The study drug and placebo are given according to the study protocol. The trial includes a treatment period lasting up to 52 weeks, with follow-up monitoring extending to 84 weeks to assess safety and side effects. During the study, participants will undergo evaluations including liver biopsies to measure changes in liver fibrosis, blood tests for liver enzymes and fibrosis biomarkers, and genetic assessments. Researchers will closely monitor side effects and the drug's behavior in the body. The main outcome is the change in quantitative liver fibrosis from baseline to week 52, with additional measures assessing liver function and disease progression. Participants' involvement may last up to 84 weeks to cover treatment and safety follow-up.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and liver fibrosis at stages F2 or F3. This Phase 3 study aims to better understand how pegozafermin may help treat liver fibrosis in this population. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections according to one of two dosing regimens. The treatments are administered in a randomized, quadruple-masked design to ensure unbiased results. The study evaluates effects after 52 weeks of treatment and monitors participants for up to 5 years to assess disease progression. During the study, participants will undergo liver biopsies to confirm fibrosis stage and will have blood tests to measure liver enzymes and fibrosis markers. Researchers will track improvements in fibrosis, resolution of steatohepatitis, changes in liver enzyme levels, and liver fibrosis scores. Participants' health and safety will be monitored throughout the study period, which includes follow-up assessments extending up to 5 years.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating the effects of two drugs, ECC4703 and ECC0509, alone and in combination, on reducing liver fat in adults with presumed Metabolic Dysfunction-associated Steatohepatitis (MASH). This Phase 2a, randomized, double-blind, placebo-controlled study aims to understand how different doses impact liver fat as measured by MRI proton density fat fraction (MRI-PDFF) at 12 weeks. Participants will be randomly assigned to one of six groups: placebo, low or high dose ECC4703, low or high dose ECC0509, or a combination of high doses of both drugs. All treatments are given as oral capsules. The main treatment period lasts 12 weeks, during which the impact on liver fat and other related health markers will be assessed. During the study, participants will undergo various assessments including MRI scans to measure liver fat, blood tests to monitor liver enzymes and metabolic markers, and other biomarker evaluations at baseline and Week 12. Safety and drug levels will be monitored throughout. The study involves close follow-up to track changes in liver fat content and related health outcomes over the 12-week treatment period.

Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease (PD) under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participant's needs. During the study, participants will complete Parkinson's Disease diaries to track "On" and "Off" motor states, and researchers will measure changes in "Good On" time and "Off" time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.

Researchers are studying efimosfermin in people with metabolic dysfunction-associated steatohepatitis (MASH) who have compensated cirrhosis confirmed by liver biopsy with stage F4 fibrosis. The study aims to evaluate the safety, tolerability, early effectiveness, and how the body processes efimosfermin in this group. Participants will be randomly assigned to one of three groups: receiving either a lower dose or higher dose of efimosfermin or a placebo. All treatments are given by subcutaneous injection once every four weeks. This is a double-blind study, so neither participants nor researchers know which treatment is given to ensure unbiased results. During the study, participants will be monitored for up to 100 weeks to track any treatment-related side effects. Blood samples will be taken up to week 21 to measure efimosfermin levels and how the drug is processed in the body. Researchers will also keep track of safety and drug effects throughout the study period.

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 efficacy and safety of Afimkibart (also called RO7790121) as both induction and maintenance therapy for people with moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart treatment with placebo in participants who have shown inadequate response or intolerance to other Crohn's disease therapies. Participants will be randomly assigned to receive either Afimkibart or placebo. Those on Afimkibart will get an intravenous (IV) infusion followed by subcutaneous (SC) injections, while the placebo group receives matching IV and SC placebo treatments. The study involves treatment through induction and maintenance phases, continuing up to 52 weeks. During the study, participants will undergo evaluations of their Crohn's disease activity using clinical remission and endoscopic response measures at weeks 12 and 52. Researchers will also monitor symptoms such as stool frequency, abdominal pain, fatigue, and bowel urgency, along with quality of life assessments. Safety will be tracked for up to 70 weeks after baseline, including monitoring adverse events and presence of fistulas. The total duration of participation may extend through this period for comprehensive assessment.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared to placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study aims to understand how well Afimkibart works and its safety profile in this population. Participants will be randomly assigned to receive either Afimkibart or a placebo. Those in the Afimkibart group will receive the drug first through an intravenous (IV) infusion followed by a subcutaneous (SC) injection. The placebo group will receive matching placebo treatments by IV and SC as well. The study treatment period includes these induction therapies, with monitoring continuing up to 30 weeks for safety. During the study, participants will be assessed for clinical remission at 12 weeks, which is the primary outcome. Other evaluations include changes in partial Modified Mayo Score, endoscopic improvement and remission, histologic improvements, bowel urgency, abdominal pain, fatigue, and health-related quality of life. Safety will be monitored by recording adverse events throughout the study. Participants will have visits for these assessments and monitoring over the course of the study duration.