Country: Moldova

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  • CT-EU-00115472

    To evaluate the safety and effects of GS-0272 in patients with rheumatoid arthritis or lupus

    A clinical trial is being introduced focusing on a new drug called GS-0272, intended for people with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The goal of this study is to gather more information about GS-0272, especially regarding its safety and good tolerability when administered in multiple doses.

    The Phase 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of GS-0272 in adult participants with rheumatoid arthritis or systemic lupus erythematosus. The study will be conducted at multiple sites, and participants will be randomly assigned to receive the study drug GS-0272 or a placebo administered subcutaneously.

    The main goals of this study are to understand how safe GS-0272 is and how participants’ bodies respond to it after receiving multiple doses. Adverse events or serious adverse events will be closely monitored, as will any changes in laboratory test results that may indicate that the medicine is not well tolerated. Additionally, the study will examine how GS-0272 travels and is processed by the body, which is known as pharmacokinetics.

    This study is an important step in determining whether GS-0272 may be a beneficial treatment option for people with RA or SLE. The safety and well-being of participants are the highest priority and a commitment has been made to provide all necessary information and support throughout the study.

    • GS-0272- new potential medication for Rheumatoid Arthritis and Systemic Lupus Erythematosus
    • placebo
  • Exploring new treatment options for rheumatoid arthritis with the new drug Resomelagon

    The RESOLVE trial will investigate the effectiveness and safety of the new treatment option AP1189 (Resomelagon) in adults with rheumatoid arthritis (RA) who have not achieved relief with methotrexate (MTX) alone. This study is divided into two main parts, each focusing on different aspects of treatment to ensure a thorough assessment.

    In the first part of the study, participants will be randomly assigned to receive one of three different doses of AP1189 (Resomelagon) or placebo, in addition to their ongoing MTX treatment. This phase will last 4 weeks and is intended to determine the most effective dose of AP1189 by observing changes in the severity of RA symptoms, specifically looking for a 20% improvement in symptoms as measured by the American College of Rheumatology (ACR20) criteria. The results of this stage will help in selecting the dose for the next part of the study.

    The second part extends the treatment period to 12 weeks, during which participants will continue selected doses of AP1189 or placebo, along with stable MTX treatment. The primary objectives are to further evaluate the effectiveness of AP1189 by observing changes in ACR20 compared to baseline and to monitor the safety and tolerability of treatment by recording any adverse events that occur.

    This study provides an opportunity for RA patients who have not responded well to MTX alone to potentially improve symptoms and contribute to the development of a new treatment option. The safety and well-being of participants is of the utmost importance and should be monitored and assessed regularly to ensure any risks are minimized.

    • placebo
    • Resomelagon/AP1189