Bihac

Researchers are studying participants with Relapsing Multiple Sclerosis (RMS) to compare how the body processes ublituximab when given as a subcutaneous (under the skin) injection versus an intravenous (IV) infusion. This Phase 3, open-label, parallel-group, multicenter study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological, and clinical effects of these two methods of administering ublituximab. The purpose is to understand if the subcutaneous form is not inferior to the intravenous form. Participants will receive ublituximab either by IV infusion or subcutaneous injection. The study includes ongoing treatment and monitoring to assess how the drug behaves in the body and its effects. The comparison focuses on the area under the curve (AUC) of ublituximab concentration from the start of treatment through 24 weeks. During the study, participants will undergo assessments including clinical evaluations and radiological tests to monitor disease status and treatment effects. Safety and pharmacodynamic measures will be recorded throughout the study. The total treatment and observation period includes at least 24 weeks of follow-up to evaluate the drug's profile and impact on participants with RMS.

This research aims to evaluate whether the drug CYB704, a proposed biosimilar to Ocrevus, works similarly to the original Ocrevus treatment in adults with relapsing multiple sclerosis (RMS). The study focuses on comparing how CYB704 is distributed in the body, its treatment effects, and side effects to those of Ocrevus. It is a Phase 3 clinical trial that seeks to demonstrate pharmacokinetic similarity and assess efficacy, safety, pharmacodynamics, and immunogenicity. Participants will receive either CYB704 or Ocrevus (from the US or EU) through intravenous infusions. The study is randomized, double-blind, and parallel-group in design. Participants will undergo at least 15 treatment visits involving drug administration and clinical checkups. Regular magnetic resonance imaging (MRI) scans will be performed to monitor disease activity and treatment effects. Throughout the study, participants will have various assessments including neurological evaluations and safety monitoring. The primary outcome measure focuses on the area under the concentration-time curve during weeks 1 to 3 and weeks 3 to 25 to assess drug pharmacokinetics. The total involvement includes treatment visits, MRI scans, and clinical tests to provide comprehensive data on the effects and safety of the treatments over time.

Researchers are evaluating the safety and effectiveness of a drug called Imeroprubart in adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. This Phase 2b study is conducted at multiple centers and uses a randomized, double-blind, placebo-controlled design to compare Imeroprubart with a placebo in participants with active CIDP. Participants receive either Imeroprubart or a matching placebo by subcutaneous injection once a week. The treatment is given for 24 weeks during the first period, followed by an extension period of 52 weeks for continued monitoring. Imeroprubart is dosed once weekly by injection under the skin, and the placebo group receives matching injections during the initial 24 weeks. Throughout the study, participants undergo various assessments to monitor their health and response to treatment. Researchers measure the proportion of participants who remain free from disease relapse by Week 24. Safety and efficacy are closely tracked with clinical evaluations and diagnostic tests. The total duration of participation includes the treatment periods and follow-up to observe outcomes and potential side effects.