Carlsbad

Researchers are evaluating whether donanemab slows the progression of cognitive decline, which affects thinking, learning, memory, attention, and decision-making, as well as functional decline impacting daily activities. This study focuses on adults aged 55 to 85 who have early cognitive decline along with Lewy Body Dementia features and confirmed brain amyloid and alpha-synuclein pathology. The trial is a phase 2 treatment study sponsored by Eli Lilly and Company, lasting one and a half years per participant. Participants are randomly assigned to receive either donanemab or a placebo, both given as intravenous infusions. Donanemab is being studied to assess its effects compared to placebo in this population. The treatment period lasts for 52 weeks, during which participants receive regular infusions under medical supervision. During the study, participants will undergo various assessments including cognitive and functional tests such as the Clinical Dementia Rating - Sum of Boxes CDR-SB, Integrated Alzheimers Disease Rating Scale iADRS, and Alzheimers Disease Assessment Scale - Cognitive Subscale ADAS-Cog13. Brain imaging and cerebrospinal fluid analysis will also be performed to measure amyloid plaque levels and alpha-synuclein pathology. Safety and drug levels in blood will be monitored throughout, with participants being followed closely for one and a half years total.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

Researchers are evaluating the effectiveness of two different doses of the drug AP-472 as an add-on treatment to levodopa in people with Parkinsons disease who experience motor fluctuations. This Phase 2 study aims to compare the effects of AP-472 at 100 mg and 300 mg per day against a placebo. Participants will be adults aged 30 to 80 years with mild to moderate Parkinsons disease and specific motor symptoms. Participants will be randomly assigned to receive either a low dose of AP-472, a high dose of AP-472, or a placebo. The study is double-blind, meaning neither participants nor study staff will know who receives which treatment. The study includes a screening period, followed by a 4-week period where Parkinsons medications must remain stable, and then an 8-week treatment period during which limited adjustments to levodopa are allowed if needed. During the study, participants will complete motor diaries to track their symptoms, and researchers will assess changes in daily OFF time and other Parkinsons disease-related scales and questionnaires. The main measurement is the change in average daily OFF time after 12 weeks. Safety and efficacy will be monitored throughout the study, which lasts about 12 weeks in total.

Researchers are evaluating a new subcutaneous formulation of ocrelizumab for adults with multiple sclerosis MS. This Phase 1b study focuses on assessing the safety and tolerability of this formulation in participants diagnosed with primary progressive or relapsing MS. The trial aims to better understand how the drug behaves in the body and its immune response effects over time. Participants will first enter a dose-escalation phase lasting 24 weeks, during which they will receive single ascending doses of ocrelizumab combined with recombinant human hyaluronidase rHuPH20 as a subcutaneous injection. Those who choose to continue will enter a dose-continuation phase, receiving the selected dose every 24 weeks for up to 144 weeks, totaling a possible 168 weeks of treatment exposure. Throughout the study, participants will undergo regular safety monitoring for adverse events and immune response, including blood tests to measure drug levels and antibodies against ocrelizumab and rHuPH20. The main outcome is the number of participants experiencing adverse events during the study. The total duration of participation may extend up to 168 weeks, with ongoing evaluations to assess tolerability and the bodys response to the treatment over time.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating the safety and effectiveness of different drug treatments in people with myasthenia gravis, a condition that affects muscle strength. This platform study uses a single master protocol to test multiple treatment regimens in separate groups called intervention-specific appendixes ISAs. The goal is to find the best treatments that reduce side effects and improve quality of life for patients with this disease. The study includes various treatment groups, such as those receiving intravenous infusions of efgartigimod, empasiprubart, or placebo, and subcutaneous administration of efgartigimod PH20 via pre-filled syringe. Each ISA has its own screening, treatment, and safety follow-up periods, which vary in length and design. Two ISAs are included one evaluating empasiprubart as add-on therapy to efgartigimod in people with partial responses, and another assessing empasiprubart monotherapy. Participants are involved in screening and treatment phases, with assessments of safety, tolerability, and effectiveness lasting up to about seven years depending on the ISA. Researchers will monitor clinical symptoms, side effects, and quality of life during and after treatment. The study aims to gather detailed information on how well these drug regimens work and their impact on patients living with myasthenia gravis.

This research aims to evaluate the safety and therapeutic importance of empasiprubart as an add-on treatment to efgartigimod in adults with AChR-Ab seropositive generalized myasthenia gravis who have a partial clinical response to efgartigimod. It is part of the ADAPT Forward platform study, which looks at the safety and effectiveness of different drugs to find the best ways to reduce side effects and improve quality of life for people with myasthenia gravis. Participants first complete screening and then enter a run-in period part A receiving efgartigimod intravenously. Those eligible move on to the add-on period part B, receiving both efgartigimod and empasiprubart intravenously. Participants not eligible for part B continue to a safety follow-up period part C where they receive efgartigimod only. The total study duration is approximately 54 weeks per participant. Throughout the study, participants undergo assessments including monitoring for adverse events, measuring changes in MG-ADL and QMG scores, and evaluating clinical responses. Researchers track safety and efficacy up to 21 weeks during parts A and B. Participants have scheduled visits for treatment and safety evaluations, with ongoing observation through the safety follow-up period to monitor treatment effects and side effects.

Researchers are studying tanruprubart, also known as ANX005, in people aged 12 to 85 who have Guillain-Barr Syndrome GBS. This open-label Phase 3 study aims to understand how the drug moves through and affects the body, as well as its early effectiveness and safety. The study is conducted in the United States, Canada, and Europe and is sponsored by Annexon, Inc. Participants will receive a single intravenous infusion of tanruprubart at a dose of 30 mgkg on the first day of the study. There are no other treatment groups or placebo arms all participants get the study drug. The trial focuses on monitoring drug levels and biological effects up to 15 days after infusion. During the study, researchers will measure how much tanruprubart is in the blood over time and the time to reach the highest concentration. They will also assess changes in a protein involved in the immune response and muscle strength scores up to one week after treatment. The total participation period includes assessments through day 15, with safety and efficacy monitored throughout.

Researchers are conducting a study to compare bone mineral density BMD measurements from two types of low-dose X-ray exams EOSedge and traditional DXA. The study aims to determine if the T-scores calculated from these two imaging methods agree. This multi-center, prospective, controlled, cross-sectional agreement study involves participants who either need EOSedge imaging as part of their routine care or volunteers undergoing non-diagnostic imaging. Participants will undergo both EOSedge and DXA scans. EOSedge exams will be performed as usual for evaluating spinal or orthopedic conditions, while DXA exams will be done as study-prescribed or standard care, ideally on the same day as EOSedge but up to 60 days apart. Healthy volunteers will receive both imaging tests, and those receiving EOSedge imaging as standard care will also receive an additional DXA scan. During the study, participants will have demographic and diagnostic information collected via case report forms and complete a questionnaire before the DXA scan. The researchers will assess the agreement of T-scores between the two imaging methods over a period of up to 60 days. The total duration of participation covers consent through completion of image acquisition. Safety is monitored by excluding participants with conditions affecting imaging quality or safety risks.

Researchers are evaluating the efficacy and safety of Imeroprubart in adults with active Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a condition affecting the peripheral nerves. This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study aims to understand how well Imeroprubart works compared to placebo in treating CIDP. The study is sponsored by Immunovant Sciences GmbH and focuses specifically on adults meeting diagnostic criteria for typical or variant forms of CIDP. Participants will receive either Imeroprubart or a matching placebo by subcutaneous injection once weekly. The treatment period includes an initial 24-week phase Period 1 with Imeroprubart or placebo, followed by an extension to 52 weeks Period 2 for continued evaluation. Imeroprubart dosing is given once weekly via subcutaneous injection. Placebo is provided similarly during the first 24 weeks. During the study, participants will be monitored through clinical assessments including relapse status by Week 24, as well as measurements of disability, grip strength, muscle strength, and symptom scores. Electrodiagnostic tests support diagnosis at baseline. Safety and efficacy will be closely observed during treatment, with follow-up visits scheduled to assess outcomes. The total participation duration covers at least 24 weeks for the primary outcome assessment, with ongoing monitoring as defined by the study protocol.