Foxborough

Researchers are investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the safety and effectiveness of ublituximab in older adults aged 55 to 80 years who have relapsing forms of multiple sclerosis (RMS). This study aims to understand how well ublituximab is tolerated in this age group, as previous studies excluded patients over 55. The main focus is on measuring the rate of infections, including urinary tract infections and other acute or chronic infections, as well as the occurrence of treatment-emergent and serious adverse events over a 24-month period. Participants will receive the drug ublituximab, either as newly treated patients or those expected to begin treatment within six months prior to joining the study. The study is conducted at a single center and involves approximately 20 participants. The treatment and observation period lasts about 24 months, during which participants will have around six visits to the study site. During the study, participants will be monitored for infections and any adverse events related to the treatment from the start until the end of the 24 months. Researchers will carefully assess the nature and severity of any side effects. The study includes regular evaluations to ensure safety and to collect information on how well patients tolerate the medication. Participation involves ongoing follow-up visits to track health status and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate the efficacy and safety of telitacicept in treating generalized myasthenia gravis (gMG), an autoimmune disease where autoantibodies disrupt nerve-to-muscle communication, causing muscle weakness that worsens with activity. The study addresses the challenge of limited effective therapies for this condition. Telitacicept is a fully human fusion protein designed to block specific immune system signals that promote B-cell growth and maturation, potentially reducing autoimmune symptoms in gMG. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension. Participants will receive subcutaneous injections of either telitacicept or placebo. The study includes a 4-week screening period, a 24-week double-blind treatment phase, a 48-week open-label extension, followed by a variable-duration extended open-label extension until telitacicept is approved or development ends, and an 8-week end-of-study follow-up. Participants will undergo assessments including the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score to measure changes in daily functioning by Week 24. The study also monitors safety and efficacy over the treatment and extension periods. Throughout the trial, various clinical evaluations will be conducted to track disease status and response to treatment, ensuring comprehensive monitoring of participant health and outcomes.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are evaluating the effects of BMS-986368, a FAAH/MAGL inhibitor, on spasticity in people with Multiple Sclerosis (MS). This Phase 2 study aims to assess the drug's efficacy, safety, and tolerability by comparing three different doses of BMS-986368 to a placebo in participants who have experienced MS-related spasticity for at least six months. Participants will receive oral doses of BMS-986368 or placebo at specified times. The study includes four groups: three groups receive different doses of BMS-986368, and one group receives a placebo. Treatment is administered according to a set schedule, and the trial is conducted at multiple centers with a double-blind design to ensure unbiased results. During the study, participants' spasticity levels will be measured using the Total Numeric-transformed Modified Ashworth Scale focusing on the most affected lower limb at week 6. Additional evaluations include safety and tolerability assessments. Participants are monitored throughout the treatment period for changes in spasticity and any side effects. The study includes adults aged 18 to 70 years with specific MS-related disability and spasticity criteria.

Researchers are evaluating the safety and effectiveness of the drugs abemaciclib and letrozole in people with advanced or recurrent estrogen receptor positive (ER+), mismatch repair proficient, TP53 wild-type endometrial cancer. This phase 2, single-arm trial focuses on maintenance therapy after participants have received chemotherapy with carboplatin and paclitaxel, with or without anti-PD-(L)1 immunotherapy. Abemaciclib and letrozole are approved for other uses but not yet for endometrial cancer. The study aims to assess progression-free survival over up to 2 years. Participants will receive oral tablets of abemaciclib, a cyclin-dependent kinase (CDK) inhibitor, and letrozole, an aromatase inhibitor, as maintenance treatment for up to 2 years. Some participants may have also received pembrolizumab, an intravenous anti-PD-(L)1 antibody, during prior treatment. The study includes screening, treatment visits, and various imaging scans such as X-rays, CT, MRI, and PET scans to monitor response. Participants will have blood tests, electrocardiograms (EKGs), and other assessments throughout treatment and will be followed for 3 years after completing the study drugs. Researchers will measure progression-free survival and monitor safety. About 32 people are expected to participate. The study is supported by Eli Lilly, who provides funding and the study drug abemaciclib.