Stellenbosch

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

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.

Researchers are evaluating whether different doses of the medicine called BI 3000202 can help adults with moderate to severe systemic lupus erythematosus (SLE). This phase II study is designed to find the best dose of BI 3000202 for people living with this condition. Participants must have a confirmed diagnosis of SLE with specific disease activity and antibody markers. Participants are randomly divided into five groups. Four groups receive varying doses of BI 3000202, while one group receives a placebo that looks like the real medicine but contains no active drug. All participants continue their usual SLE treatments during the study. The tablets are taken daily for one year. During the study, participants visit the study site regularly for health checkups and to monitor any side effects. Researchers measure the treatment's effectiveness by the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at week 32. The total participation time is a bit longer than one year, during which safety and health are closely observed and compared between groups.

Researchers are evaluating whether an Artificial Intelligence (AI) based computer program can automate two important parts of the radiotherapy treatment process for cancer patients. This includes outlining anatomical areas at risk of tumor spread and radiation damage, and defining the position, size, and shape of radiation beams. The study focuses on patients with cervical, head and neck, and prostate cancers who are receiving radical radiotherapy. The AI program works by uploading the patient's CT scan to a web-based system called the Radiotherapy Planning Assistant. This system automatically contours the targeted organs and areas at high risk and plans the radiotherapy beams. However, in this study, patients will receive the manual treatment plans created by local medical teams, not the AI-generated plans. The AI-generated plans will be evaluated for quality and clinical acceptability before treatment. Participants will have their radiotherapy treatment plans reviewed to see if the contours and dosimetry meet predefined clinical standards before starting treatment. The study measures how well the AI plans meet these criteria compared to standard human-made plans. Participants must be adults with confirmed cancer types and consent to radical radiotherapy. The study also involves clinical peer review of the plans to ensure safety and effectiveness.

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 tuberculosis infection (LTBI). This trial focuses on people at higher risk of developing active tuberculosis and is conducted in various settings with different TB incidence rates. The study aims to test if the shorter treatment is not worse than the longer standard treatments in terms of safety and effectiveness. Participants are randomly assigned to either the experimental group receiving 600 mg of rifapentine daily for 6 weeks or to a control group receiving one of three standard treatments: 12 weeks of once-weekly rifapentine and isoniazid, 12 weeks of daily rifampin and isoniazid, or 16 weeks of daily rifampin. Dosage adjustments are made based on patient weight according to established guidelines. A total of 1,120 participants will be assessed for safety and 3,400 for effectiveness, followed for 24 months after enrollment. During the study, participants will be monitored for treatment discontinuation due to adverse drug reactions and for the development of tuberculosis. Safety and effectiveness will be evaluated by comparing the rates of drug discontinuation and new TB cases between the two groups. Follow-up includes clinical assessments and laboratory tests over a 24-month period to ensure comprehensive monitoring of participant health and treatment outcomes.

Researchers are evaluating the safety and pharmacokinetics of ambulatory antibiotic treatments for newborns with "all-risk" asymptomatic congenital syphilis. This phase II, randomized, open-label study aims to understand how these treatments behave in the body and their safety profile in this vulnerable population. The study focuses on infants born to mothers with various levels of syphilis risk during pregnancy, including untreated or inadequately treated cases. The study compares three antibiotic treatments: a ten-day course of oral Linezolid at 10 mg/kg twice daily, a ten-day course of oral Amoxicillin at 50 mg/kg twice daily, and a single intramuscular dose of Benzathine Penicillin G at 50,000 IU/kg. Participants receive one of these treatments during the study period. Throughout the study, researchers will monitor the time the antibiotics remain above the minimum inhibitory concentration (MIC) in blood serum and cerebrospinal fluid over 10 days. Safety is assessed by tracking adverse events from enrollment through 24 weeks. Participants will be evaluated through clinical assessments and monitoring to ensure treatment tolerability and to collect relevant pharmacokinetic data.

Researchers are studying the long-term safety and tolerability of ianalumab in adolescents and adults with moderate-to-severe systemic lupus erythematosus who test positive for anti-nuclear antibodies. This extension study involves participants who previously completed treatment in one of two core SIRIUS-SLE studies. The aim is to monitor how well ianalumab is tolerated over an extended period compared to a placebo. The study compares monthly or quarterly subcutaneous injections of ianalumab to monthly placebo injections. Participants receive these treatments after completing the initial core studies (CVAY736F12301 or CVAY736F12302). This extension phase focuses on continued monitoring of these treatments over a long time frame. Participants will be observed for treatment-emergent adverse events and serious adverse events for up to approximately 91 months. Assessments include monitoring safety and tolerability throughout the study period. The total participation duration depends on individual study completion, with ongoing evaluation to ensure participant well-being during this extended follow-up.

This research aims to assess the long-term safety of secukinumab in participants who have finished a previous Novartis secukinumab trial and are judged by their investigator to benefit from continued treatment but cannot access the marketed secukinumab form. The study focuses on individuals with autoimmune or inflammatory conditions and is conducted as a Phase 4 trial to monitor treatment safety over an extended period. Participants will receive secukinumab through subcutaneous injections using pre-filled syringes. The study is open-label and multi-center, designed for patients continuing secukinumab therapy after completing a parent study or in cases where the parent study ended prematurely for non-safety reasons. Treatment continuation depends on investigator judgment regarding benefit and risk balance. During the study, participants will be observed for up to two years to evaluate safety by tracking any adverse or serious adverse events. The study includes regular assessments to monitor participant health and treatment effects. Consent and communication with investigators are essential, and participants may sign informed consent or assent forms according to age and local laws. Overall participation duration and detailed safety monitoring are key components of the study.