Berea

Researchers are evaluating the potential of GB-0895, an investigational drug, as an additional treatment for adolescents and adults with severe asthma that is not well controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of GB-0895 over one year, with an optional extension phase. The study includes participants aged 12 to 80 years with documented severe uncontrolled asthma despite current therapy. Participants will be randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every six months during the 52-week treatment period. The study also includes phases for screening and run-in before treatment, followed by a follow-up period lasting up to 38 weeks after treatment ends. An optional open-label extension allows participants to continue receiving GB-0895 at specified weeks after the initial treatment phase. During the study, participants will attend visits every 1 to 2 months after the first month to monitor health and treatment effects. Assessments include lung function tests, asthma symptom questionnaires, quality of life evaluations, and tracking of asthma exacerbations. Researchers will closely monitor safety and treatment responses through these evaluations and collect data on various health measures to understand the drugs impact on severe asthma over the course of the study.

Researchers are evaluating lenacapavir LEN, a long-acting study drug, combined with other medicines for treating adolescents and children living with HIV-1 who weigh at least 35 kg and have prior treatment experience. The study aims to assess the safety, tolerability, and pharmacokinetics of LEN when used with an optimized background regimen OBR in this population. It also explores how easy it is for participants to take LEN either as an injection or an oral pill. Participants will start by taking oral LEN tablets 600 mg on Days 1 and 2. They will also receive two doses of LEN 927 mg as subcutaneous injections on Day 1 and at Week 26, alongside their usual OBR treatment. At Week 52, participants may choose to continue receiving subcutaneous LEN injections every six months for at least two more doses during an extension phase, while maintaining their OBR. During the study, researchers will monitor participants closely through blood tests to measure LEN levels and assess safety, including any treatment-emergent side effects or laboratory abnormalities, up to Week 52. They will also evaluate how well the virus is controlled by measuring plasma HIV-1 RNA levels and changes in CD4 cell counts. Participants will complete questionnaires about their experience with oral LEN, and safety and tolerability will be observed throughout the treatment and extension periods, which may last beyond one year.