Stellenbosch

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 medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Researchers are evaluating the safety and effectiveness of a new short 6-week daily rifapentine treatment compared to the standard 12-16 week rifamycin-based treatments for latent Mycobacterium tuberculosis infection LTBI. This trial focuses on people at higher risk of developing active tuberculosis TB and is conducted in locations with varying TB rates where LTBI treatment is routinely provided. The study aims to determine if the shorter treatment is not less safe or effective than the longer standard treatments. Participants are randomly assigned to one of two treatment groups the experimental group receives 600 mg of rifapentine daily for 6 weeks, while the control group receives one of three standard regimens lasting 12 to 16 weeks, including combinations of rifapentine, isoniazid, and rifampin. Dose adjustments are made based on patient weight following established guidelines. Treatments are given according to random assignment and participants are followed for 24 months to assess outcomes. During the study, researchers monitor treatment completion rates, adverse drug reactions, and new cases of active tuberculosis. Safety assessments include tracking serious side effects and drug discontinuation rates. Effectiveness is measured by the occurrence of culture-confirmed or clinical TB within 24 months of enrollment. The study involves regular evaluations and follow-up visits over two years to collect data on treatment tolerability, safety, and TB prevention outcomes.

Researchers are studying ambulatory antibiotic treatments for neonates with all-risk asymptomatic congenital syphilis in a randomized, open-label phase II trial called CARES-1. The study aims to evaluate the pharmacokinetics and safety of different antibiotic options to improve treatment approaches for this vulnerable newborn population. Participants are randomly assigned to one of three treatment groups a 10-day course of oral Linezolid given twice daily at 10 mgkg, a 10-day course of oral Amoxicillin given twice daily at 50 mgkg, or a single intramuscular dose of Benzathine Penicillin G at 50,000 IUkg. These treatments are provided in an ambulatory setting to assess their effectiveness and tolerability in newborns. During the study, infants will be monitored from enrollment through day 10 for antibiotic levels in blood and cerebrospinal fluid, and adverse events will be tracked for up to 24 weeks. Clinical outcomes will be evaluated through week 24 to assess treatment impact. This includes measuring time above minimum inhibitory concentrations and AUCMIC ratios in serum and CSF. Safety and treatment effects will be closely observed throughout the study duration.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-mycobacterial activity of bedaquiline TMC207 combined with a standard background regimen of medications in children and adolescents aged from birth up to less than 18 years who have confirmed or probable pulmonary multidrug resistant tuberculosis MDR-TB. This phase 2 study aims to better understand how the drug works in this population and assess its effects alongside other MDR-TB treatments. Participants are grouped into four age-based cohorts, each receiving a dose of bedaquiline adjusted for their age and weight. Cohorts 1 and 2 include older children and adolescents who start with daily dosing for two weeks followed by three times weekly dosing for 22 weeks. Younger children in Cohorts 3 and 4 receive weight-based doses with similar schedules. All participants take bedaquiline along with a background regimen of MDR-TB medications according to WHO and national guidelines. During the study, participants undergo regular monitoring of drug levels in their blood at various weeks up to 120 weeks for older cohorts and 88 weeks for the youngest cohort. Researchers also track adverse events, treatment outcomes, and time to culture conversion from clinical samples. The study involves long-term follow-up to evaluate safety, drug behavior, and treatment success over time.

This trial focuses on participants with autoimmune or inflammatory conditions who have previously taken part in a Novartis secukinumab study. It aims to evaluate the long-term safety of continuing secukinumab treatment in those who the investigator judges will benefit and who cannot obtain the marketed secukinumab formulation. The study is an open-label extension phase 4 trial sponsored by Novartis Pharmaceuticals. Participants will receive secukinumab injections under the skin at doses of 75 mg, 150 mg, or 300 mg every four weeks, depending on their dose in the prior trial. For those who had intravenous secukinumab, the starting dose will be 300 mg subcutaneously. Dosing may be adjusted based on clinical need and investigator judgment. Pediatric dosing will not exceed the maximum dose evaluated for their weight group in the previous trial. During the study, participants will be monitored for up to two years to assess safety, focusing on adverse events and serious adverse events. They will have regular assessments including communication with investigators and follow study requirements. The total study duration extends up to April 2030, with ongoing evaluation to ensure participants continue to benefit from treatment while monitoring for any risks.