Willowbrook

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 the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

Researchers are evaluating the effectiveness and safety of current standard treatments for adults with active systemic lupus erythematosus SLE, including lupus nephritis, who have not responded adequately to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with ongoing active disease despite prior treatments, aiming to better understand treatment outcomes in this population. The study is observational and sponsored by Bristol-Myers Squibb. Participants will continue to receive their current standard of care treatments as prescribed, which may include biologic therapies and other immunosuppressants, according to product labels and treatment guidelines. Those with lupus nephritis must have had a recent renal biopsy confirming specific kidney involvement. The study observes participants over time without altering their treatment, collecting data on disease activity and response. During the study, participants will be monitored regularly for up to five years. Assessments include clinical evaluations, laboratory tests, and disease activity questionnaires to track remission status, kidney function, disease flare-ups, and fatigue levels. The primary outcome is the number of participants achieving remission at six months. Secondary outcomes include long-term remission, kidney response, disease activity states, and patient-reported fatigue. Safety and treatment response duration will also be recorded throughout the study period.

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 evaluating the efficacy and safety of Afimkibart also known as RO7790121 compared with placebo in adults with moderate to severe rheumatoid arthritis RA who have not responded well to or cannot tolerate tumor necrosis factor TNF inhibitors andor Janus kinase JAK inhibitors. This Phase II, double-blind, placebo-controlled study aims to better understand how Afimkibart works for patients with this challenging form of RA. Participants in this study will receive Afimkibart or a matching placebo by subcutaneous injection. The study uses a randomized, parallel design with multiple groups receiving either Afimkibart or placebo. Dosing schedules and injection details are consistent across groups, with treatment effects assessed over a period including baseline, Week 14, and Week 24 timepoints. The study also includes monitoring of drug concentration and immune response markers up to Week 38. During the study, participants will be regularly assessed for changes in RA disease activity using scores such as DAS28-CRP and DAS28-ESR, joint counts, global assessments, pain levels, disability questionnaires, and inflammation markers. Safety is monitored through adverse event tracking and antibody testing. The total study duration includes treatment and follow-up periods lasting up to 38 weeks, allowing researchers to evaluate both short- and longer-term effects of the study drug.

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 dapirolizumab pegol DZP as an add-on treatment to standard care medications for people with moderate to severe active systemic lupus erythematosus SLE. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess whether DZP can achieve meaningful long-term improvement in disease activity compared to placebo. Participants must have been diagnosed with SLE at least 24 weeks prior and meet specific disease activity and serological criteria. Participants will be randomly assigned to receive either dapirolizumab pegol or placebo throughout the treatment period. Both groups will continue their stable standard of care medications, which may include antimalarials, glucocorticoids, andor immunosuppressants. The study is designed with a parallel group structure and masking to ensure unbiased assessment of efficacy and safety over a treatment period extending up to 48 weeks. During the study, participants will be monitored regularly to assess disease activity using tools such as the British Isles Lupus Assessment Group Disease Activity Index 2004 BILAG 2004 and Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI-2K. Researchers will track responses at Week 48 and evaluate additional outcomes like flare prevention, fatigue levels, glucocorticoid dose reduction, and safety events. Follow-up will continue up to Week 54 to monitor adverse events, ensuring comprehensive evaluation of participant health and treatment effects.

Researchers are studying the drug JNJ-88545223 to see how well it works compared with a placebo in adults who have active psoriatic arthritis PsA. This study aims to determine if JNJ-88545223 can reduce the signs and symptoms of PsA and improve the health of joints and skin. The trial is a randomized, double-blind phase 2b study designed to evaluate different doses of the drug. Participants will be randomly assigned to receive one of four treatments from Week 0 to Week 16 placebo, or one of three doses of JNJ-88545223. Each group will receive their assigned treatment under blinded conditions to compare the effects. The study focuses on evaluating the efficacy and safety of these doses over the 16-week treatment period. During the study, participants will undergo regular assessments to measure treatment effects, including the American College of Rheumatology ACR 50 response at Week 16 as the primary outcome. Additional evaluations include skin severity indexes PASI responses, physical function questionnaires, and quality of life surveys. Safety and symptoms will be monitored throughout the trial, which lasts approximately 16 weeks for each participant.

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.