Caguas

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 evaluating budoprutug, a humanized IgG1 monoclonal antibody that targets CD19 cells, in adults with active, seropositive Systemic Lupus Erythematosus (SLE) who have not responded adequately to standard treatments. This Phase 1b open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness of budoprutug in this population. Participants will receive a single intravenous infusion of budoprutug on the first day of the study in ascending dose groups. The study focuses on how the drug affects B cells and antibody levels in the blood over time after the infusion. During the study, researchers will monitor participants for treatment-emergent adverse events and laboratory abnormalities up to 24 weeks. Vital signs including blood pressure, heart rate, respiratory rate, body temperature, and ECG parameters will be measured to assess safety. The study will track changes from baseline in these measures and collect data on pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy over the 24-week period.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating combination chemotherapy treatments for patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) and relapsed favorable histology Wilms tumors (FHWT). This phase II trial aims to assess how adding vincristine and irinotecan to standard chemotherapy regimens affects event-free survival and overall survival compared to historical data. The study also explores kidney toxicity, tumor genetics, and radiation therapy techniques to reduce side effects in children with lung and liver metastases. Two chemotherapy regimens are studied. Arm I (Regimen UH-3) involves cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan given intravenously on specific days every 21 days. Radiation therapy is given around week 7 of cycle 3 if needed. Arm II (Regimen ICE/Cyclo/Topo) includes cycles of ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan given intravenously every 21 days, with surgery and/or radiation during certain cycles. Both arms include multiple cycles in absence of disease progression or unacceptable side effects. Participants undergo various scans like CT, PET, MRI, chest x-rays, ultrasounds, and bone scans throughout the trial. Blood samples and biopsies may be collected periodically. After treatment, patients are followed up every 3 months for the first 2 years, every 6 months for years 3-4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years, along with monitoring kidney health and treatment effects.

Researchers are evaluating the effectiveness and safety of eloralintide compared to a placebo for reducing body weight in adults who have overweight or obesity along with type 2 diabetes. This Phase 3, randomized, double-blind study focuses on participants who have been on stable treatment for their type 2 diabetes and aims to provide detailed information on body weight changes over time. Participants will receive either eloralintide or a placebo administered by subcutaneous injection once weekly. The study lasts about 75 weeks, including treatment and follow-up periods. The goal is to monitor the changes in body weight from the beginning of the study through week 64. During the study, participants will undergo various assessments to track body weight and overall health. Researchers will collect data on weight changes and monitor safety throughout the study period. The main outcome measured is the percentage change in body weight from baseline to week 64, ensuring close observation of participants' responses to the treatment.

Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on weight loss in adults who are overweight or have obesity along with type 2 diabetes. This Phase 2 study aims to understand how these treatments might help reduce body weight in this population. The study is designed as a parallel-group, double-blind, placebo-controlled trial to ensure unbiased results. Participants will receive either macupatide, eloralintide, both drugs together, or matching placebos. All treatments are administered by subcutaneous injection. The study treatment period lasts approximately 48 weeks, during which the effects of the drugs on weight and diabetes control will be assessed. During the study, participants will be monitored for changes in body weight from the start of the study to week 32 as the primary outcome. Researchers will also evaluate safety and other health measures throughout the nearly year-long participation. The study includes regular assessments to track the effects of treatment and to ensure participant health and safety.

Researchers are evaluating the safety and effectiveness of obexelimab in adults with systemic lupus erythematosus (SLE). Participants must have had an SLE diagnosis for at least 24 weeks and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria. Eligible patients must have active SLE with specific disease activity scores and be receiving certain standard lupus treatments such as oral corticosteroids, antimalarials, or immunosuppressants. The study includes a 24-week treatment period where participants are randomly assigned to receive either obexelimab or a placebo through weekly subcutaneous injections. Before treatment, there is a screening period lasting up to 28 days, and after the treatment phase, participants enter a 12-week follow-up period. Visits to the study site occur at weeks 2, 4, and then every 4 weeks throughout the study. During the study, participants will undergo regular assessments to monitor treatment effectiveness, safety, drug levels, immune response, and overall health. The maximum time a participant can be involved in the study, including screening and follow-up, is about 40 weeks. Researchers will collect data to evaluate how well obexelimab works and its safety profile in managing SLE symptoms.

Researchers are evaluating the effects of selumetinib compared to the standard treatment with carboplatin and vincristine (CV) in patients aged 2 to 21 years with newly diagnosed or previously untreated low-grade glioma (LGG) that lacks the BRAFV600E mutation and is not linked to systemic neurofibromatosis type 1 (NF1). This phase III study aims to determine if selumetinib is as effective as the current standard treatment and to assess which treatment is better, including its impact on patients' quality of life. The trial also explores tumor response rates, visual and motor function outcomes, and cognitive and social functioning in children with LGG. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive intravenous vincristine and carboplatin in an induction phase with specific dosing days, followed by a maintenance phase with repeated cycles every 42 days for up to eight cycles, unless disease progression or unacceptable toxicity occurs. In the second group, patients take oral selumetinib twice daily in 28-day cycles for up to 27 cycles, also until progression or unacceptable toxicity. Throughout the trial, patients undergo blood sample collection, magnetic resonance imaging (MRI), and in the selumetinib group, echocardiography (ECHO) at baseline. Participants are monitored during treatment and followed after completion every 3 months for the first year, every 6 months for years two and three, and then annually up to 10 years. The study measures event-free survival (EFS) as the primary outcome over this period. Additional assessments include visual acuity tests, motor function evaluations, quality of life questionnaires, cognitive and emotional function assessments, and collection of biological samples for future studies. Safety is monitored continuously to track any treatment-related effects or complications.

Researchers are evaluating the effectiveness and safety of upadacitinib at different doses in adults with moderate to severe atopic dermatitis (AD) who have not responded adequately to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation, and some people require systemic treatments beyond topical therapies. This phase 3b/4 study aims to provide data on upadacitinib's impact on AD symptoms in this specific population. The study is conducted in two open-label periods. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg orally once daily or dupilumab 300mg by subcutaneous injection every two weeks. After two weeks, those on upadacitinib 15mg may have their dose increased to 30mg based on their response. Period 2 lasts 24 weeks, during which participants either continue their assigned dose or switch doses depending on their eczema severity scores. The entire treatment duration is 32 weeks with follow-up for 30 days after treatment ends. Participants will undergo regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires to evaluate treatment effects. The main outcome measured is the number of participants achieving at least a 90% improvement in their eczema severity index by week 8. The study includes a 35-day screening period before treatment begins and monitors safety and efficacy throughout the study duration.

Psoriatic arthritis (PsA) is a long-lasting inflammatory condition that affects the joints and skin in people with psoriasis (PsO). This research aims to evaluate how well the drug zasocitinib (TAK-279) works in adults with active PsA who have not previously used biologic disease-modifying antirheumatic drugs. The study is a Phase 3 clinical trial designed to compare zasocitinib against an active comparator and placebo in this patient group. Participants will receive treatment with either zasocitinib tablets, an active comparator capsule, or a matching placebo. The study includes multiple groups to assess the effects of these treatments. Participants will be followed and treated for up to 60 weeks during the study period. During the study, participants will undergo assessments to measure the percentage achieving improvement according to the American College of Rheumatology 20 (ACR20) response at 16 weeks. Researchers will monitor symptoms, joint and skin involvement, and overall safety throughout the trial. Participants will have regular visits for evaluations and will be observed for treatment effects and any side effects over the full course of the study.