Germiston

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

Researchers are evaluating the safety, how the body processes, and how well the study medicine nirmatrelvirritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but at risk of severe illness. This trial is a Phase 3, open-label study focusing on nonhospitalized pediatric patients with COVID-19 to better understand the effects of this oral medication. The study medicine is given by mouth as tablets or powder twice daily for 5 days, totaling 10 doses. Different dosing forms and amounts are used depending on the participants age and weight, ranging from under 1 month old up to 18 years. Participants are assigned to one of several groups based on these factors to receive the medicine accordingly. During the study, participants will have blood samples taken to measure drug levels at specific times, and researchers will monitor for any side effects or changes in vital signs up to 34 days after starting treatment. They will also measure viral load through nasal swabs at several points over 28 days and assess hospitalizations or deaths related to COVID-19. Participants feedback on the medicines taste and acceptability will be collected during treatment.

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.