Colleyville

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating VENT-03 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

Researchers are evaluating the effectiveness of adding tirzepatide to ongoing ixekizumab therapy in adults with active psoriatic arthritis PsA who are overweight or obese and have at least one weight-related health condition. This Phase 4 study aims to assess how well this combination works in real-world clinical practice over a 12-month period. Participants will continue their current ixekizumab treatment and begin taking tirzepatide, which is administered by subcutaneous injection as directed by the medication label. The study involves a single treatment group where all participants receive this combination therapy, with treatment lasting up to 12 months. During the study, participants will be monitored regularly to assess joint symptoms, skin involvement, disease activity, pain, fatigue, physical and mental health, and weight changes. Researchers will collect data at multiple time points, including baseline, 6 months, and 12 months, using questionnaires, joint counts, and physical assessments. The primary outcomes focus on improvements in disability and weight loss after 12 months of therapy.

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are evaluating bimekizumab administered intravenously compared to subcutaneous injection in adults with active psoriatic arthritis or active axial spondyloarthritis. The study aims to show that the intravenous method is not less effective than the subcutaneous method by assessing how the drug moves in the body over time. This is a Phase 1, open-label, randomized, parallel-group study focused on treatment. Participants will receive one of three dosing regimens of bimekizumab during a pharmacokinetics lead-in phase and continue with the same assigned regimen during the treatment period. The dosing regimens include intravenous and subcutaneous administration of bimekizumab at specified times. Subjects are randomized into one of two experimental arms reflecting different intravenous regimens or a third arm receiving the subcutaneous regimen. During the study, participants will be monitored for steady-state trough concentration of the drug at week 16. Safety is assessed by tracking treatment-emergent adverse events, serious adverse events, and any events leading to withdrawal from the study through week 29. The study duration extends to the end of safety follow-up, with regular assessments to evaluate drug levels and participant health under medical supervision.

Researchers are evaluating the medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.

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.

Researchers are evaluating sonelokimab in adults with active psoriatic arthritis who have not had adequate results or could not tolerate prior anti-tumor necrosis factor TNF alpha therapy. This Phase 3, multicenter, randomized, double-blind study compares the safety and effectiveness of two doses of sonelokimab against placebo and an active reference treatment called risankizumab. Participants are randomly assigned to one of four groups one receiving sonelokimab dose 1, another receiving sonelokimab dose 2, one receiving placebo, and one receiving risankizumab. Those in the sonelokimab groups receive four initial subcutaneous doses as induction, then maintenance doses every four weeks starting at Week 8. The placebo and risankizumab groups receive their respective treatments subcutaneously according to the study protocol. During the study, participants will undergo assessments of joint tenderness and swelling, skin psoriasis activity, physical function, and quality of life at Week 16. Researchers will monitor response rates based on improvement criteria such as the American College of Rheumatology 50% improvement ACR50. Safety and tolerability will also be followed throughout the trial, which is expected to complete by January 2027.