St. Clair Shores

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

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 investigating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels in adults with hyperuricemia related to gout. This phase 3, randomized, double-blind trial focuses on adults aged 18 to 75 who have had gout for at least one year and experienced multiple gout flares in the past year. The study aims to assess the percentage of participants achieving an sUA level below 6.0 mg/dL at 24 weeks. Participants receive either dotinurad or allopurinol as oral over-encapsulated tablets. Allopurinol doses range from 200 mg/day for those with moderate kidney impairment to 600 mg/day, with participants maintaining a stable dose for at least three months before starting the study. The trial includes a 24-week treatment period where the effects of these medications on uric acid levels are monitored and compared. During the study, participants undergo regular assessments including serum uric acid measurements at screening and throughout the 24 weeks. Female participants of childbearing potential have pregnancy tests and must agree to contraception requirements. Researchers monitor safety, treatment adherence, and gout flare history to evaluate the treatments' efficacy and tolerability over the study period.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid (sUA) levels at 24 weeks in adults with tophaceous gout. This condition involves the presence of measurable tophi, or deposits of uric acid crystals, in joints such as hands, wrists, feet, or ankles. The study is a Phase 3, randomized, double-blind, multicenter trial focused on adults aged 18 to 75 years who have had gout for at least one year. Participants receive either dotinurad or allopurinol in over-encapsulated tablet form, taken orally. The treatments are compared to see which better lowers sUA levels below 5.0 mg/dL after 24 weeks. The study includes a screening period before treatment begins, during which eligibility is confirmed, including measurements of tophi size and uric acid levels. During the study, participants will have regular assessments to monitor serum uric acid levels and the size of tophi. Safety and side effects will also be monitored throughout the 24-week treatment period. The main outcome is the percentage of participants who achieve sUA levels less than 5.0 mg/dL at week 24, helping to understand the comparative efficacy and safety of the two medications.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, including granulomatosis with polyangiitis or microscopic polyangiitis. This phase 4 randomized, double-blind, placebo-controlled trial focuses on participants newly diagnosed or experiencing a relapse who require induction treatment with cyclophosphamide or rituximab and have specific antibody positivity and disease activity criteria. Participants will receive oral avacopan or placebo alongside standard of care immunosuppressive therapy for induction and maintenance, tailored by the investigator according to guidelines and patient needs. The study monitors treatment effects and safety over an extended period, up to 60 months, assessing adverse events and clinical changes. Throughout the study, participants will undergo regular evaluations including vital signs, blood tests, and urinalysis to detect any significant changes from baseline. The main outcomes measured include the percentage of participants experiencing various types of adverse events, serious adverse events, and events leading to withdrawal or death, all tracked up to 60 months to ensure comprehensive long-term safety data.

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 Pantheris SV catheter, an optical coherence tomography-guided directional atherectomy device, to treat peripheral artery disease in arteries below the knee. This post-market, single-arm study focuses on patients with reduced blood flow in the lower extremity arteries. The study aims to collect data on artery narrowing before and after the atherectomy and monitor symptoms and adverse events for up to one year after the procedure. Participants will undergo directional atherectomy of lesions located in the infragenicular segment using the Pantheris SV system. After the atherectomy, additional therapy may be applied if the physician deems it necessary. The study includes follow-up assessments at 30 days, 6 months, and 1 year to document adverse events and symptom resolution. During the study, researchers will assess major adverse events from the procedure up to 30 days afterward and technical success one day after the procedure. Participants will be monitored through scheduled visits to evaluate the restoration of blood flow and overall safety. The total participation time includes the procedure day and follow-up visits extending to one year post-treatment.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.