Menifee

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 ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.

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 safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.