Red Oak

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.

Researchers are studying adults with Systemic Lupus Erythematosus SLE or Rheumatoid Arthritis RA, chronic autoimmune and inflammatory diseases, to assess how the drug ABBV-519 behaves in the body, its effects, and safety. This Phase 1 study focuses on participants with moderate SLE or RA and aims to understand the pharmacokinetics, pharmacodynamics, and safety profile of ABBV-519. Participants will receive a single dose of ABBV-519 either by intravenous infusion or subcutaneous injection. The study includes five groups receiving different doses of the drug. The total study duration is approximately 425 days, which includes a 60-day screening period, a 1-day treatment period, and a 52-week follow-up period to monitor participants after treatment. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in B cells, drug concentration in blood over time, detection of anti-drug antibodies, and adverse events. The long follow-up period allows careful monitoring of participants health and the drugs effects.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 years who have mild to severe Alzheimers Disease AD with moderate to severe psychosis related to AD. This Phase 3 study aims to compare KarXT with a placebo to see how well it works in treating psychosis symptoms associated with AD, focusing on changes in hallucinations and delusions. Participants will receive either KarXT capsules at varying doses or placebo capsules in a randomized, double-blind setup. The treatment period lasts up to 14 weeks, during which participants take the assigned capsules daily. The study design includes two groups running in parallel, with neither participants nor researchers knowing who receives the drug or placebo. During the study, participants will undergo assessments including the Neuropsychiatric Inventory-Clinician NPI-C focusing on hallucinations and delusions, Clinical Global Impressions-Severity scale, and other related scales to measure psychosis symptoms and caregiver distress. Safety and efficacy will be monitored throughout, with evaluations at baseline and at the end of treatment. The entire participation period extends up to 14 weeks.

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody ANCA-associated vasculitis AAV, a condition requiring immunosuppressive therapy. This Phase 4 clinical trial aims to assess how participants tolerate avacopan combined with standard care over an extended period. The study involves participants diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis who need induction treatment with cyclophosphamide or rituximab. Participants are randomly assigned to one of three groups avacopan 30 mg twice daily for five years plus standard care, avacopan 30 mg twice daily for one year followed by placebo twice daily for four years plus standard care, or placebo twice daily for five years plus standard care. Standard care involves background immunosuppressive therapy guided by current guidelines and tailored to each participants needs. Treatments are administered orally, and the study is double-blind to ensure objective assessment. During the study, participants will be monitored regularly for treatment-emergent adverse events, serious adverse events, and changes in vital signs and laboratory tests over up to 60 months. Researchers will also evaluate remission rates, relapse timing, kidney function, health perception scores, and medication use. Safety and efficacy data will be collected through clinical assessments, laboratory evaluations, and questionnaires, with follow-up continuing for the full duration of the trial.

Researchers are evaluating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis RA, a chronic inflammatory condition causing joint pain, stiffness, swelling, and loss of function. This Phase 2 study involves three substudies focusing on different drug treatments to assess their effectiveness and safety for participants who have not responded to one or two prior biologic or targeted synthetic DMARD therapies. Participants will be randomly assigned to receive one of several treatments lutikizumab alone, ravagalimab alone, a combination of lutikizumab and ravagalimab, or matching placebos. These drugs are given by subcutaneous injection. The study involves regular visits at hospitals or clinics where participants receive the assigned treatment and are monitored closely. The treatment period and detailed dosing schedules are part of the studys design. During the trial, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects, side effects, and disease activity. The main outcomes measured include the percentage of participants achieving a 50% improvement according to the American College of Rheumatology criteria by Week 12 and the number of adverse events up to approximately Week 22. Participants will attend regular visits for evaluations throughout the study period, which is expected to complete by November 2027.

Researchers are evaluating the safety and effectiveness of AlloNK, a non-genetically modified allogeneic natural killer NK cell therapy derived from cord blood, combined with rituximab, in people with relapsing forms of B-cell dependent rheumatologic diseases. These diseases include refractory rheumatoid arthritis, Sjgrens disease, idiopathic inflammatory myopathies, and systemic sclerosis. This open-label Phase 2a study aims to explore treatment options for patients whose conditions have not responded well to previous therapies. Participants receive AlloNK after a conditioning regimen, followed by rituximab. AlloNK is an off-the-shelf, cryopreserved NK cell therapy given in combination with rituximab. The treatment period lasts up to 104 weeks, during which participants are monitored for safety and clinical response. The study includes one treatment group receiving this combination therapy. Throughout the study, participants undergo regular assessments to evaluate safety from enrollment until the end of treatment at Week 104. Researchers measure disease-specific outcomes at Week 52, including disease activity scores for rheumatoid arthritis, Sjgrens disease activity indices, improvement scores for inflammatory myopathies, and response indices for systemic sclerosis. The study involves clinical evaluations, laboratory tests including inflammatory markers, and joint assessments to monitor treatment effects and safety over the extended period.

Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.