Colleyville

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating the treatment outcomes of subcutaneous anifrolumab 120 mg once weekly as add-on therapy to antimalarials, with or without glucocorticoids (GCs), in patients with systemic lupus erythematosus (SLE) who have not previously used immunosuppressants or biologics. The study focuses on patients not in Lupus Low Disease Activity State (LLDAS) at enrollment and aims to describe clinical outcomes such as achieving DORIS remission, while also understanding GC tapering and withdrawal possibilities. This is a Phase 3, open-label, single-arm study. Approximately 275 participants aged 18 to 70 will receive anifrolumab subcutaneously once weekly for 52 weeks following a screening period of up to 35 days. Participants may increase their GC dose until week 4 based on investigator recommendation, then those on more than 5 mg/day GC at entry will attempt a taper to 5 mg/day over 12 weeks between weeks 5 and 40. Participants achieving DORIS remission for two visits will then attempt complete GC withdrawal with a 12-week taper. After week 41 until study end, no further GC dose reductions will occur. Following treatment, a 12-week safety follow-up is included for those not continuing anifrolumab. Participants will undergo assessments including clinical evaluations, laboratory tests, and questionnaires to monitor disease activity, remission status, and safety. Researchers will measure attainment of DORIS remission at week 52 as the primary outcome. Study evaluations will include ANA and other antibody testing, infection screening, HPV testing, and adherence to study procedures. The total study duration is approximately 69 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in adults with active psoriatic arthritis (PsA) who are overweight or obese and have at least one weight-related health issue. This Phase 4 study aims to understand how well this combination works in standard clinical practice over a period of up to 12 months. The focus is on improving physical function and achieving weight loss in this patient group. Participants will receive tirzepatide administered by subcutaneous injection after having been treated with ixekizumab for about three months. The study is open-label and single-arm, meaning all participants will get tirzepatide alongside their ongoing ixekizumab therapy. Treatment will begin within 30 days after deciding to add tirzepatide. No placebo or comparison group is mentioned. During the study, researchers will monitor participants for up to 12 months, measuring their physical functioning using the Health Assessment Questionnaire Disability Index and tracking weight loss. Safety and treatment effects will be assessed through regular evaluations. The study seeks to see how many participants achieve improved function and at least 10% weight loss by the end of the 12-month therapy period.

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

This research aims to compare two ways of giving the drug bimekizumab to adults with active psoriatic arthritis or active axial spondyloarthritis. The study focuses on whether giving bimekizumab through an intravenous (IV) injection is not worse than giving it as a subcutaneous (under the skin) injection. The trial is designed as an open-label, randomized, parallel-group, noninferiority phase 1 study to evaluate how the drug moves and stays in the body over time. Participants will receive bimekizumab at scheduled times either through one of two intravenous regimens or a subcutaneous regimen. Each group will follow a specific dosing plan to see how the drug behaves in the body depending on the method of administration. The study treatments are given at pre-set time points, and the goal is to measure drug concentrations in the blood. During the study, participants will be monitored and assessed for the drug concentration in their blood at week 16 to understand steady-state trough levels. Researchers will also check for safety and tolerability throughout the study. The total duration and further assessments are not specified, but the focus is on comparing the drug levels and safety between the different administration methods in adults with these active conditions.

Researchers are evaluating whether different doses of the medicine called BI 3000202 can help adults with moderate to severe systemic lupus erythematosus (SLE). This phase II study is designed to find the best dose of BI 3000202 for people living with this condition. Participants must have a confirmed diagnosis of SLE with specific disease activity and antibody markers. Participants are randomly divided into five groups. Four groups receive varying doses of BI 3000202, while one group receives a placebo that looks like the real medicine but contains no active drug. All participants continue their usual SLE treatments during the study. The tablets are taken daily for one year. During the study, participants visit the study site regularly for health checkups and to monitor any side effects. Researchers measure the treatment's effectiveness by the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at week 32. The total participation time is a bit longer than one year, during which safety and health are closely observed and compared between groups.

Researchers are evaluating if a modified form of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who experience new low back or leg pain due to acute lumbosacral musculoskeletal conditions, including spinal stenosis and sciatica. This is a double-blind, randomized, placebo-controlled Phase 4 study comparing the active drug to a look-alike placebo. The purpose is to measure changes in pain and how it affects physical activity and sleep over one week. Participants will be randomly assigned to receive either metaxalone 640 mg oral tablets along with standard care or a placebo that looks the same but contains no active drug. The study consists of an initial pilot phase followed by a larger phase with more participants to confirm results. Treatments are taken as oral tablets, and participants continue their usual care. During the study, participants will complete surveys on Day 1 before starting treatment and again on Day 7 to report pain levels, pain quality, and how pain affects their physical activity and sleep. Researchers will monitor changes in pain using a Numeric Pain Scale from Day 1 to Day 7. Participants must be able to respond to text or email reminders for surveys. The total study duration for each participant is 7 days of treatment and follow-up.