Zadar

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 effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis, a chronic autoimmune disease. This phase 2, randomized, double-blinded, placebo-controlled study aims to assess how well the treatment works and its safety profile. Participants have systemic sclerosis with specific skin involvement and meet classification criteria, with the study sponsored by argenx. Eligible participants will be randomly assigned in a 21 ratio to receive either subcutaneous efgartigimod PH20 SC or a placebo, both given by prefilled syringe. The treatment period lasts up to 48 weeks, followed by a safety follow-up period. The total duration of the study can be up to approximately 15 months, including screening, treatment, and follow-up. Participants will undergo screening to confirm eligibility and then receive regular doses of the study drug or placebo during the treatment phase. Assessments include changes in skin thickness measured by the modified Rodnan Skin Score mRSS at 24 and 48 weeks, safety monitoring for adverse events, and evaluations of disability, patient and clinician assessments, lung function, and antibody levels. The study also tracks pharmacokinetics, immunogenicity, and antibody responses throughout the treatment and follow-up periods.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.