Germiston

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of different doses of ELV001 in treating active rheumatoid arthritis (RA) in patients who have not responded well to methotrexate and tumor necrosis factor inhibitors. The trial plans to enroll around 180 to 220 adult participants aged 18 to 75 years with active RA meeting specific clinical criteria. The study aims to measure changes in disease activity using the DAS28-C-reactive protein score from baseline to week 12. The study includes four groups receiving placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. Participants receive treatment for 24 weeks, starting with a 4-week screening period. The first 12 weeks are double-blind and placebo-controlled, followed by a treatment extension from weeks 12 to 24 where some participants may have their ELV001 dose adjusted. After treatment, a 4-week safety follow-up period monitors participants for any adverse effects. Participants will have regular assessments including blood tests, joint evaluations, and monitoring of disease activity scores throughout the study. Researchers will track medication adherence and safety through physical exams, laboratory tests, and ECGs. The primary outcome focuses on improvement in disease activity at week 12. The total study duration for each participant is about 32 weeks from screening to the end-of-study visit.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

This research aims to learn about the safety, how the body processes, and how well the study medicine called nirmatrelvir/ritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but are at risk for severe illness. The study focuses on pediatric patients confirmed to have COVID-19, with early symptoms and risk factors for worsening disease. Participants will receive the study medicine, which is given by mouth, to evaluate its effects. The trial is open-label, meaning both researchers and participants know the treatment being given. The study is designed as a single-arm Phase 2/3 trial conducted at multiple centers. During the study, researchers will measure medicine levels in the blood at specific times to understand drug absorption and processing. They will monitor for any side effects or adverse events up to 34 days after starting treatment. Vital signs and other health indicators will be regularly checked to assess safety and overall health. The total participation period includes treatment and follow-up to gather comprehensive safety and effectiveness data.

Researchers are evaluating the safety, tolerability, and effectiveness of long-acting lenacapavir (LEN) combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have previously been treated for HIV-1. The study focuses on treatment-experienced participants and aims to learn more about LEN's pharmacokinetics and safety when used alongside an optimized background regimen (OBR). Participants will receive LEN either as tablets taken without regard to food or as subcutaneous injections, combined with an optimized background regimen prescribed by the investigator. The study is open-label and single-arm, focusing on the effects of LEN combined with OBR over the course of the trial. During the study, participants will be monitored for LEN levels in their blood at Week 26, as well as for any treatment-emergent adverse events or laboratory abnormalities through Week 26. Researchers will assess the participants' health, laboratory tests, and side effects to better understand the drug's safety and antiviral activity. The study includes adolescents and children up to 17 years old who meet specific health criteria and treatment histories.