Carlsbad

Researchers are evaluating the bioequivalence of two subcutaneous formulations of ocrelizumab in adults with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). This phase II study aims to compare a test formulation of ocrelizumab with the marketed reference formulation to understand if they behave similarly in the body. Participants include those diagnosed based on the revised McDonald criteria, with an Expanded Disability Status Scale (EDSS) score between 0 and 6.5. The study has two phases: a controlled phase where participants receive a single dose of either the test or reference ocrelizumab formulation, followed by a continuation phase where all participants receive the test formulation. Both treatments are administered subcutaneously according to the study schedule. The design is randomized, open-label, parallel group, and multicenter. During the study, researchers will monitor the body's response to the medication by measuring serum concentration levels, including the area under the concentration-time curve and maximum serum concentration over 12 weeks after dosing. Participants undergo screening and evaluations to confirm eligibility and safety. The study excludes those with recent anti-CD20 treatments, certain medical histories, or other conditions that might interfere with the study. The age range for participants is 18 to 65 years, and both genders are eligible.

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 effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating the safety and effectiveness of different drug treatments for people with myasthenia gravis, a condition affecting muscle strength. This platform study uses a single master protocol to test multiple treatment plans through separate intervention-specific appendixes. The goal is to find the best treatment options that reduce side effects and improve quality of life for participants with myasthenia gravis. The study includes treatments such as intravenous infusions of efgartigimod and empasiprubart. Each intervention-specific appendix outlines its own screening, treatment, and safety follow-up periods with varying durations. One example is the evaluation of empasiprubart as an add-on therapy to efgartigimod in participants with a certain antibody-positive generalized myasthenia gravis. Participants will undergo initial screening under the master protocol, followed by screening specific to each intervention appendix. During the study, researchers will monitor safety, tolerability, and efficacy of the treatments over periods that can last up to approximately seven years. Assessments include clinical evaluations and monitoring for side effects to determine the best therapeutic approaches for myasthenia gravis management.

Researchers are evaluating the safety and therapeutic benefit of empasiprubart as an add-on treatment to efgartigimod in adults with AChR-Ab seropositive generalized myasthenia gravis who have only partially responded to efgartigimod alone. This Phase 2a exploratory trial is part of the larger ADAPT Forward platform study, which aims to identify the best treatments to reduce side effects and improve quality of life for people with myasthenia gravis. After completing initial screening, eligible participants enter a run-in period (part A) receiving intravenous efgartigimod. Those eligible then proceed to an add-on period (part B) receiving both intravenous efgartigimod and empasiprubart. Participants not qualifying for part B continue to a safety follow-up period (part C) with efgartigimod only. The total study duration for each participant is approximately up to 54 weeks. During the study, researchers monitor the incidence of adverse events and serious adverse events for up to 21 weeks. Assessments include safety, tolerability, and efficacy measurements throughout the different study periods. Participants undergo evaluations and receive treatments intravenously while safety follow-up continues to ensure well-being during and after treatment phases.

Researchers are evaluating the safety, tolerability, and antiviral effectiveness of ARN-75039, a new oral antiviral medication, for treating Lassa fever in adults hospitalized in West Africa. This Phase 2, randomized, open-label clinical trial is conducted within the INTEGRATE platform and compares two different oral doses of ARN-75039 (100 mg twice daily and 50 mg twice daily) with the standard intravenous ribavirin treatment. The study aims to assess antiviral activity by measuring changes in viral load and includes participants confirmed to have Lassa virus infection by RT-PCR. Participants are randomly assigned in equal groups to receive either the high-dose ARN-75039, low-dose ARN-75039, or intravenous ribavirin for a 10-day inpatient treatment period. The ARN-75039 treatment includes an initial loading phase followed by tapered twice-daily oral dosing designed to achieve and maintain effective drug levels while minimizing side effects. All participants also receive supportive care according to local standards. The study is conducted at specialized centers equipped for Lassa fever management and pharmacovigilance under coordinated African and U.S. regulatory oversight. During the 28-day study period, which includes treatment and follow-up phases, participants undergo continuous safety monitoring for adverse events and clinical outcomes such as symptom resolution, organ failure, and mortality. Researchers collect viral load data through RT-PCR testing to evaluate antiviral effects and perform pharmacokinetic sampling in patients receiving ARN-75039 to understand drug exposure. Additional assessments include laboratory tests, electrocardiograms, physical exams, and monitoring for potential viral resistance. The results will help guide further development of ARN-75039 as a treatment for Lassa fever.

Researchers are comparing bone mineral density (BMD) measurements obtained from two different low-dose X-ray imaging methods: EOSedge and traditional DXA scans. This study aims to determine if the T-scores calculated from these two types of exams agree with each other. It is a multi-center, prospective, controlled, cross-sectional agreement study involving subjects who are either indicated for EOSedge imaging or volunteers undergoing non-diagnostic imaging. Participants will undergo both EOSedge and DXA scans. EOSedge exams will be conducted as usual for evaluating spinal or orthopedic conditions, providing images for later BMD calculation. DXA exams, focusing on the lumbar spine and bilateral femoral necks, will be performed either on the same day as EOSedge or within a 60-day window. Data collected will include imaging results, demographic and diagnostic details, and questionnaire responses completed before the DXA scan. Throughout the study, participants will be assessed using both imaging methods to compare BMD T-scores. Researchers will collect spine and posture alignment parameters from the images and gather demographic and diagnostic information through case report forms. The main outcome measured is the agreement of AP spine T-scores between the two imaging methods within 0-60 days. Participants provide informed consent and must be able to comply with study requirements.

Researchers are conducting a Phase 3 study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of ABP 692 with Ocrelizumab (both US and EU versions) in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show similarity between these treatments by measuring how the drugs behave in the body and their effects on suppressing new active brain lesions over 24 weeks using MRI scans. Participants will receive intravenous infusions of either ABP 692, Ocrelizumab (US), or Ocrelizumab (EU). The study design allows comparison between these three groups to assess how the drugs are processed and how well they control disease activity. Infusions are given according to the study schedules, and the effects are monitored over the following weeks. During the study, participants will have regular assessments including brain MRI scans to count new lesions, blood tests to measure drug levels, and neurological evaluations to track disease status. The main outcomes include drug concentration over time and the number of new brain lesions up to week 24. Safety and clinical effects will also be observed throughout the study period, which includes screening and follow-up visits.

Researchers are evaluating the effectiveness and safety of Qualia NAD+, a dietary supplement designed to support the maintenance and enhancement of intracellular NAD levels. The study aims to determine if Qualia NAD+ can increase NAD+ levels in the blood compared to a placebo in healthy adults aged 40 to 65 years. Participants will be randomly assigned to receive either Qualia NAD+ or a placebo daily for 4 weeks. The placebo used in this trial contains rice flour, which has no active drug. The study is conducted as a randomized, double-blind, parallel trial to compare the effects of the supplement and placebo without bias. During the study, participants will undergo blood tests before and after the 4-week intervention to measure NAD+ levels in the blood. They will also complete questionnaires, records, and diaries related to the trial. Participants will self-administer a fingerstick test at home to collect blood samples. Safety and adherence will be monitored throughout the study period.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.