Zadar

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

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 effect and safety of efgartigimod PH20 SC compared to placebo in adults diagnosed with systemic sclerosis (SSc). This phase 2 randomized, double-blinded, placebo-controlled study aims to understand how this treatment impacts skin involvement measured by the modified Rodnan Skin Score (mRSS) in affected individuals. The study includes participants with diffuse or limited SSc who meet specific classification criteria and antibody test requirements. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous efgartigimod PH20 SC via prefilled syringe or a matching placebo. The study consists of a screening period, followed by a treatment period lasting up to 48 weeks, and then a safety follow-up phase. The total duration of participation may be approximately 15 months. During the study, participants will have regular evaluations including assessments of skin thickness using the mRSS to measure changes from baseline at week 24. Researchers will monitor safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity throughout the trial. Additional assessments may include disability and patient global assessment scores, antibody testing, and skin evaluations at injection sites.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Follicular lymphoma (FL) is the second most common B-cell cancer and the most frequent cancer of lymphocytes, but it is incurable with standard treatments and often returns. This research is a Phase 3 trial evaluating the safety and effectiveness of the investigational drug epcoritamab combined with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in adults who have not been treated for FL before. The study aims to assess adverse events and changes in disease activity among about 1095 participants worldwide. Participants are assigned to one of five treatment groups receiving different therapies. Treatments include R2 alone or combined with subcutaneous epcoritamab injections. Some may receive chemoimmunotherapy options chosen by investigators, including R-CHOP, G-CHOP, R-Benda, or G-Benda, involving various intravenous infusions and oral tablets. Most treatment arms last 120 weeks, except one lasting 24 weeks. The study treatments involve intravenous infusions, oral capsules or tablets, and subcutaneous injections. During the study, participants regularly visit hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will track responses such as complete response rates at 30 months and progression-free survival up to 10 years. The study also monitors safety and tolerability throughout. Participants’ treatment adherence and disease status will be carefully observed over the study period.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.