Schaumburg

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

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 changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

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 a specific oral corticosteroid OCS tapering schedule to reduce steroid use in adults with acetylcholine receptor positive generalized myasthenia gravis gMG who are treated with intravenous ravulizumab. This phase 4, multicenter, single-arm study aims to assess both the effectiveness and safety of gradually lowering OCS doses while managing gMG symptoms. Participants will follow a predefined oral corticosteroid tapering schedule during the study period until they complete the tapering process. They will continue receiving ravulizumab as part of their standard medical care, along with prednisone or prednisolone as needed. The treatment period lasts up to approximately 32 weeks, focusing on reducing or discontinuing OCS while monitoring disease status. Throughout the study, researchers will assess how many participants can reduce their daily OCS dose to 5 mg or less, or stop it entirely, without worsening gMG for at least four weeks. They will also track changes in quality of life, daily living activities, and glucocorticoid toxicity. Participants will undergo regular evaluations and safety monitoring during the study, which runs from March 2026 to August 2027.

Researchers are collecting and evaluating long-term clinical and X-ray data to better understand the safety and performance of shoulder arthroplasty over time. This observational study follows patients for at least 10 years to observe outcomes without a set limit on follow-up duration. The study includes people with various shoulder conditions such as osteoarthritis, rotator cuff tears, fractures, and infections. Participants in this study have undergone or are indicated for shoulder arthroplasty surgery. The study tracks their progress over time through regular clinical and radiographic assessments. Various outcome scores like the Constant score, ASES, Oxford Score, TESS, and MSTS are measured approximately once per year throughout the study period to evaluate shoulder function and recovery. During the study, participants will attend scheduled visits where clinical exams and imaging are performed to monitor their shoulder health and prosthesis performance. They will complete questionnaires related to their condition and function. The study aims to gather comprehensive long-term data on shoulder arthroplasty outcomes, with follow-up lasting at least 10 years from enrollment.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating Telitacicept, a recombinant fusion protein, in adults with active primary Sjogrens Disease, an autoimmune condition characterized by B-cell hyperactivity and autoantibody production. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of Telitacicept by modulating B-cell-mediated immune pathways through inhibiting BLyS and APRIL signaling, which are involved in disease activity. Participants will receive either Telitacicept or a placebo through subcutaneous injections as part of a parallel study design. The trial compares these two groups over a treatment period lasting 48 weeks, focusing on changes from baseline in disease activity and related symptoms. Telitacicept binds specific cytokines to reduce B-cell survival and autoantibody production, potentially impacting disease manifestations. During the study, participants will undergo assessments including the EULAR Sjogrens Syndrome Disease Activity Index ESSDAI, glandular function tests, patient- and physician-reported outcomes, and fatigue evaluations. Safety and efficacy will be monitored through these measures at Week 48. The trial spans from screening through treatment and follow-up, with a planned completion by January 2029.

Researchers are studying the effects of IMVT-1402 in adults with mild to severe generalized myasthenia gravis, a condition affecting muscle strength. This Phase 3 trial aims to evaluate the efficacy, safety, and tolerability of IMVT-1402 as a treatment option compared to a placebo. The study is randomized and triple-blinded to ensure reliable results. Participants will receive one of two doses of IMVT-1402 or a placebo, all administered by subcutaneous injection once weekly. The treatment periods include an initial 12-week phase, followed by extended dosing periods of 14 weeks and 52 weeks for some groups. The study is designed to assess responses across these timeframes. During the trial, participants will be monitored through various assessments including the MG activities of daily living MG-ADL score and the Quantitative Myasthenia Gravis QMG score. The main outcome focuses on changes in MG-ADL from baseline to week 12. Safety and tolerability will also be tracked throughout the treatment and follow-up periods. The overall participation may last up to several months depending on the treatment group.