Noida

Researchers are evaluating how well etavopivat works to reduce the number of vaso-occlusive crises (painful blood vessel blockages) in adolescents and adults living with sickle cell disease. The study also aims to assess if etavopivat can decrease organ damage, improve exercise tolerance, and reduce fatigue. This is a global Phase 3 study involving participants aged 12 years and older with confirmed sickle cell disease. The study is randomized, double-blind, and placebo-controlled to ensure accurate evaluation of the treatment effects. Participants will receive either etavopivat or a matching placebo by mouth. Which treatment they receive is determined randomly. The study will last about two years, during which participants will take the assigned medication and be monitored closely. Etavopivat is an investigational drug currently under evaluation in multiple studies for sickle cell disease. During the study, participants will have regular assessments including documentation of vaso-occlusive crisis events, blood tests, and physical evaluations. Researchers will track the number of crises that require medical attention over a 52-week period, as well as measures of organ health, exercise ability, and fatigue. Safety and overall health will be monitored throughout the study, with the total participation time lasting approximately two years.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on participants who have had UC for at least 3 months and have specific disease activity scores. The study aims to understand how well LY4268989 works in treating this condition over a long period. Participants will receive either LY4268989 or a placebo, both administered orally. The study includes a treatment period lasting up to approximately 108 weeks, not including the screening phase. Participants are monitored to assess their response to the medication, including whether they achieve clinical remission based on the Modified Mayo Score (mMS). During the study, researchers will conduct various assessments to monitor disease activity and participant safety. They will track the percentage of participants achieving clinical remission at Week 10 and among those who responded at Week 10, the remission status at Week 52. The study involves regular evaluations, including endoscopic confirmation of disease activity and safety monitoring over the entire duration.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are evaluating a couples-based financial literacy and gender-transformative program aimed at improving relationship strength, empathy, and mental health among married couples in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. This sub-study is part of a larger randomized controlled trial called Disentangling and Preventing Economic Violence against Women (ECOVI), involving approximately 2,250 husband-wife pairs across 150 clusters. The study measures changes in relationship quality and mental health from before the intervention to about six months after its completion. The intervention, named "Let us Grow Together: Economic Wellbeing for Families," consists of six structured community sessions for couples, each lasting 2.5 to 3 hours. These sessions combine financial literacy education—covering budgeting, savings, and joint financial planning—with gender-transformative content that promotes equitable household roles, communication, conflict resolution, and empathy. Sessions are delivered by trained male and female facilitators in groups of about fifteen couples every 2 to 4 weeks. Sensitive topics related to economic violence are addressed separately by gender to ensure safety and comfort. Participants also receive SMS reminders between sessions to reinforce key messages and encourage skill practice. Participants attend baseline and endline assessments before the first session and about six months after the intervention ends, respectively. These assessments include questionnaires measuring mental health, perceived relationship strength, and empathy. The study also plans to explore whether improvements in relationship quality and empathy explain changes in mental health outcomes. Safety and participation are monitored throughout, with both partners providing informed consent and agreeing to complete all sessions and assessments. The findings aim to clarify how integrating relationship-building and gender equity into economic empowerment programs impacts couples' well-being.

Researchers are evaluating the safety and how the body processes luspatercept in children aged 6 to under 18 years with beta-thalassemia, a blood disorder. This Phase 2a study includes both transfusion-dependent and non-transfusion-dependent participants. The study is divided into two parts: Part A focuses on adolescents aged 12 to under 18 years with dose escalation and expansion cohorts, while Part B will include younger children aged 6 to under 12 years after safety data from Part A is reviewed. The research aims to better understand luspatercept's effects and optimal dosing in these pediatric groups. Luspatercept (ACE-536) will be given as specified doses on set days during the treatment periods. Participants in Part A will undergo dose escalation and expansion, followed by Part B dose escalation in younger children. After completing the treatment period, those benefiting from luspatercept may continue treatment for up to five years. Participants who stop treatment will be followed for safety for at least five years from their first dose or three years after their last dose, whichever is longer. Throughout the study, researchers will monitor safety and pharmacokinetics, including drug levels and how the body absorbs and clears luspatercept, over up to one year from the first treatment day. Participants will have regular assessments, including monitoring transfusion needs and overall health. This long-term follow-up ensures careful evaluation of treatment effects and participant well-being over several years.