Rustavi

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

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 a distribution program for low dead-space syringes and needles (LDSS/N) among people who inject drugs in several low- and middle-income countries, including Armenia, Georgia, Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to identify the best ways to implement and sustain high use of LDSS/N by understanding community preferences and program feasibility. It also seeks to assess the impact of LDSS/N on blood borne virus transmission risks such as HIV and Hepatitis C. The study includes multiple phases. Initially, focus group discussions (FGDs) with people who inject drugs will help select LDSS/N products based on their preferences. Then, a 6-week pilot distribution phase will allow participants to try these products alongside usual services at needle and syringe programs (NSPs). Afterward, a scaled-up distribution of selected LDSS/N products will occur while collecting routine program data and running an observational cohort study with approximately 240 participants per country (480 in Nigeria). Participants will undergo HIV and Hepatitis C testing and complete surveys at baseline, 6, 12, and 18 months. Additional FGDs and interviews with staff and stakeholders will explore program acceptability and feasibility. Participants will attend NSP sites or outreach services to access LDSS/N and answer questions about their use. Researchers will monitor LDSS/N uptake through routine data and cohort surveys. The primary outcome is how well the community-informed LDSS/N distribution increases LDSS/N use over 18 months. Mathematical modeling will estimate the public health impact and cost-effectiveness of scaling up LDSS/N distribution. The total participant involvement includes baseline and follow-up testing and surveys over an 18-month period, alongside qualitative feedback sessions.