Bucaramanga

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an autoimmune disease where the immune system attacks the protective covering of nerves, leading to muscle weakness and loss of sensation in the arms and legs. This research aims to evaluate TAK-411, a specially modified immune globulin G derived from human plasma, to see if it can reduce inflammation and improve symptoms in adults with CIDP. The study will compare the physical functioning of participants treated with TAK-411 to a historical placebo group. Participants will receive TAK-411 through intravenous infusion for up to 51 weeks, with treatment visits occurring at the study clinic. After the treatment period, they will be followed for an additional 3 weeks. The study is open-label and designed as a Phase 2 proof-of-concept trial to assess the safety, tolerability, and effectiveness of TAK-411 in adults diagnosed with CIDP. During the study, participants may visit the clinic approximately 21 times for assessments. Researchers will measure improvements in functional ability at 24 weeks and monitor participants closely throughout the treatment and follow-up periods. The study includes physical evaluations, neurological assessments, and monitoring for any adverse effects related to TAK-411 treatment.

This research aims to evaluate the effects of EYU688 on dengue viral load, fever clearance time, and clinical signs and symptoms in patients diagnosed with dengue fever. It is a phase 2 randomized, participant- and investigator-blinded, placebo-controlled study that investigates both the efficacy and safety of orally administered EYU688 compared with a matching placebo. The study includes two parallel cohorts with different pharmacokinetic (PK) sampling schedules: an intensive PK cohort and a sparse PK sampling cohort. Participants will receive either EYU688 or placebo capsules administered orally. The treatment is given to patients who have confirmed dengue fever symptoms and a positive dengue test, with the onset of fever within 48 hours prior to starting treatment. The two cohorts run simultaneously but differ based on the frequency and intensity of PK blood sampling to assess drug behavior in the body. Throughout the study, participants will be monitored for changes in viral load measured at 48 hours after treatment begins, as well as fever duration and clinical symptoms. Assessments include laboratory tests to evaluate safety and efficacy, with careful monitoring for any adverse effects. The total duration of participation includes screening, treatment, and follow-up evaluations to ensure comprehensive data collection on the drug's impact and participant safety.

Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years with asthma. This Phase 3, double-blind, randomized, active-controlled, two-period, two-treatment cross-over study focuses on children with asthma who have lung function (FEV1) at or above 50% of the predicted normal value. The study aims to show whether QMF149 is superior to budesonide in improving asthma control. The study lasts up to 37 weeks and includes several phases: a screening period of up to 3 weeks, a 3-week run-in period where all participants receive fluticasone propionate, a first 12-week treatment period with either QMF149 or budesonide delivered once daily via Breezhaler, a 3-week washout period with fluticasone propionate, a second 12-week treatment period where participants switch treatments, and a 4-week safety follow-up where patients return to standard care as appropriate. The treatments are given once daily through an inhaler device. Participants attend scheduled visits every 3 weeks during screening and run-in, every 6 weeks during treatment periods, and a follow-up visit after safety monitoring. Assessments include lung function tests (FEV1), inhaler technique checks, symptom questionnaires, and monitoring of side effects. Researchers evaluate changes from baseline in trough FEV1 after each 12-week treatment to measure lung function. Safety information and survival status are collected at the end of the follow-up period.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.

Researchers are investigating the effectiveness of a multicomponent intervention to improve cognitive function in patients with mild cognitive impairment and their primary caregivers. Mild cognitive impairment is seen as a precursor to dementia, and this study aims to prevent its progression while also addressing the impact on caregivers, who are often family members without formal training. This pilot randomized clinical trial involves 102 patient-caregiver pairs and focuses on cognitive function and quality of life improvements. The intervention lasts 12 weeks and includes professional support twice a week at home and caregiver support once a week. Patients receive a combination of physical activity training, including dual training, strength, balance exercises, and moderate walking, along with nutritional advice that evolves monthly to reduce sugars and processed carbs, increase healthy fats, and boost fruit and vegetable intake. Cognitive training includes activities targeting orientation, attention, working memory, reasoning, language, visual skills, executive functions, and reminiscence therapy. Caregivers participate in weekly group activities focused on care, self-care, understanding cognitive decline, and supporting patient adherence. Participants will be assessed at the start and followed up at 3, 6, and 9 months to measure changes in various cognitive domains such as global cognition, memory, processing speed, attention, executive functioning, and verbal fluency. Secondary outcomes include quality of life, frailty, physical capacity, independence, nutrition, social support, and caregiver burden. Some participants will also have their intestinal microbiota and genetic markers evaluated before and after the intervention. The study includes safety and adherence monitoring throughout the participation period.

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.

Breast cancer is a leading health issue in Latin America, especially among women who tend to develop it at younger ages and are often diagnosed at more advanced stages compared to Western women. Mortality rates from breast cancer in this region have been rising rapidly over the past two decades. The study aims to better understand the causes and characteristics of breast cancer in premenopausal women in Latin America, focusing on molecular and pathological tumor subtypes, and the role of various risk factors including diet, obesity, and physical activity. The study, called PRECAMA, is a multicenter population-based case-control study conducted in Mexico, Costa Rica, Colombia, and Chile. It collects detailed clinical, pathological, and biological information from women aged 20 to 45 years who have been newly diagnosed with primary invasive breast cancer, as well as matched controls from the same regions. Participants provide information through questionnaires on socio-demographic factors, health history, reproductive history, diet, physical activity, and environmental exposures. Biological samples such as blood and urine are also collected for analysis. Participants undergo standardized measurements including body weight and height, and molecular analyses are performed on tumor samples for cases. The study evaluates breast cancer subtypes and investigates the interplay of endogenous and exogenous factors contributing to the disease. This research will help identify modifiable risk factors for breast cancer prevention and support public health strategies in Latin American countries.

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.