Arcadia

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants with non-alcoholic fatty liver disease and metabolic syndrome components, aiming to better understand treatment effects in this population. Participants will receive either Efimosfermin Alfa injection or a placebo, with the study designed as a three-arm trial. The treatment will be administered according to the study protocol, though specific dosing details are not provided. The study will monitor participants over a period extending to at least 52 weeks, comparing the safety and tolerability of Efimosfermin Alfa against placebo. During the study, participants will be closely observed through clinical assessments including monitoring for treatment-emergent adverse events (TEAEs), laboratory tests to detect Grade 3 and Grade 4 abnormalities, and evaluation of any adverse events leading to discontinuation of treatment. These safety and tolerability measures will be recorded at Week 52, helping researchers assess the impact of Efimosfermin Alfa over time.

Researchers are investigating the safety, tolerability, and effectiveness of two dosing regimens of itepekimab compared to placebo as an add-on to intranasal corticosteroids in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) that is not well controlled. This multinational Phase 3, randomized, double-blind, placebo-controlled trial involves male and female participants aged 18 years and older living with CRSwNP. Participants are randomly assigned to one of three groups receiving either itepekimab injections or placebo injections, both administered subcutaneously, alongside mometasone furoate nasal spray delivered intranasally. The study includes a 4-week screening period, followed by a 52-week treatment phase, and a 20-week safety follow-up, totaling up to 76 weeks. Participants transitioning to an extension study (LTS18420) will have a total duration of 56 weeks. Study visits include nine site visits and 20 phone or home visits. During the trial, participants will undergo assessments including endoscopic Nasal Polyp Scores (NPS) and Nasal Congestion Scores (NCS) measured from baseline to week 24 to evaluate changes. Researchers will monitor safety and tolerability throughout, with regular evaluations involving symptom severity, treatment adherence, and adverse events. The study aims to understand how well itepekimab works and is tolerated as an additional treatment for CRSwNP over the study duration.

This research aims to evaluate the safety and effectiveness of efimosfermin alfa in improving liver fibrosis and resolving steatohepatitis in adults with metabolic dysfunction-associated steatohepatitis (MASH) confirmed by biopsy showing stage F2 or F3 fibrosis. The study compares efimosfermin alfa to a placebo and focuses on individuals with confirmed liver damage and metabolic syndrome features. Participants will receive either efimosfermin alfa or placebo, administered as a drug treatment. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial with three groups. Treatment effects will be assessed over 52 weeks, with a primary focus on liver fibrosis and steatohepatitis changes. The study includes long-term monitoring of liver-related clinical outcomes up to 48 months after randomization. During the study, participants will undergo liver biopsies confirmed by central pathology review, and researchers will monitor liver function and fibrosis improvement. Outcome measures include the proportion of participants showing fibrosis improvement without worsening steatohepatitis, resolution of steatohepatitis with stable fibrosis, and time to liver-related clinical events. Safety and efficacy will be closely evaluated throughout the treatment and follow-up periods.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating adults aged 18 and older who have a specific eye condition called centre-involved diabetic macular edema (CI-DME), a type of diabetic macular edema. The study aims to find out whether an oral medicine called BI 1815368 can improve vision in people with CI-DME and to determine the best dose. This is a Phase 2 study focused on assessing the medicine's safety, efficacy, and tolerability over 48 weeks of treatment. The study has two parts. In the first part, participants are randomly assigned to one of two equal groups: one group takes BI 1815368 tablets and the other takes placebo tablets, which look like the medicine but contain no active drug. In the second part, participants are randomized into four groups of equal size, three of which receive different daily doses of BI 1815368, while one group continues to take placebo. All participants take tablets twice daily for about 11 months. Participants stay in the study for about a year and visit the study site 16 times. During visits, doctors check vision and collect detailed eye pictures along with health information. Researchers compare changes in vision and eye condition over time between the groups. The main outcome measured is whether participants gain 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of visual acuity at week 48 compared to baseline, indicating improved sight.

Researchers are evaluating the safety and effectiveness of duvakitug in people with moderately to severely active Ulcerative Colitis (UC). This multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aims to see if duvakitug can help achieve clinical remission in this condition. The study targets participants aged 16 to 80 years with a confirmed diagnosis of active UC for at least 3 months who have not responded well or are intolerant to other treatments. Participants will receive either duvakitug or a placebo as a solution injected under the skin (subcutaneous injection). The study includes up to 35 weeks with multiple periods: a screening period, a 12-week induction phase (either open-label or randomized), a 12-week extended induction for those who do not respond initially, and a 45-day follow-up for those not continuing into the maintenance study. During these phases, participants may have up to 8 to 15 on-site visits depending on their sub-study group. Throughout the study, participants will be monitored closely with scheduled visits for assessments including clinical evaluations related to UC activity and response to treatment. The main outcome measured is the proportion of participants who achieve clinical remission by week 12. Safety and tolerability will also be tracked during and after the treatment period, with follow-up visits to ensure participant well-being.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of elacestrant combined with other drugs in adults with advanced or metastatic estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. This multicenter Phase 1b/2 trial aims to find the recommended dose of elacestrant in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib in Phase 1b, and then assess the safety and efficacy of these combinations in Phase 2. During Phase 1b, participants receive elacestrant at various doses along with one of the other drugs, such as alpelisib, everolimus, ribociclib, palbociclib, capivasertib, or abemaciclib, in treatment cycles of 28 days. Phase 2 includes multiple treatment arms with fixed participant numbers per combination, evaluating these drug combinations over similar 28-day cycles. Each drug has specific dosing schedules, such as once daily or twice daily, with some requiring days off during the cycle. Participants will undergo assessments including monitoring for dose-limiting toxicities during the first 28-day cycle and progression-free survival over six months. The study involves regular evaluations of disease status and safety, including physical exams and laboratory tests. Overall, Phase 1b will have up to 125 participants, while Phase 2 will include about 310 participants across all treatment groups.

Researchers are evaluating the drug eRapa to see if it can slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). This Phase 3 trial compares eRapa to a placebo in patients who are considered high risk for disease progression. The study aims to answer if eRapa is effective and safe, how it affects the number of polyps in the gastrointestinal tract, and its impact on quality of life. Participants will be randomly assigned in a 2:1 ratio to receive either 0.5 mg of eRapa or a matching placebo orally once a day every other week. Treatment continues until the disease worsens, the participant stops the trial, or the trial endpoint is reached. Patients will have a baseline endoscopy and follow-up endoscopies every 6 months to monitor disease status. Clinic visits occur every 3 months for check-ups and tests. The trial includes patients with intact colons or those who have had surgery but still have residual polyps. During the study, participants will take their assigned capsules and attend regular clinic visits about every three months for assessments. These include endoscopies, physical exams, and other tests to track disease progression and safety. The main measure of success is progression-free survival over three years. Researchers will also monitor participants' quality of life and any side effects, ensuring ongoing safety and data collection throughout the trial.