Antony

Researchers are evaluating how well pre-treatment 68Ga-FAPI-46 PET/CT imaging can predict the histological response to neoadjuvant chemo-immunotherapy in patients with early-stage high-risk triple-negative breast cancer (TNBC). This prospective multicenter study focuses on female patients who have not yet been treated and are recommended to receive pembrolizumab combined with chemotherapy as their standard care. The study aims to improve understanding of treatment effectiveness using advanced imaging techniques before therapy begins. Participants will receive neoadjuvant treatment consisting of pembrolizumab 200 mg every three weeks combined first with four cycles of paclitaxel plus carboplatin, followed by four cycles of doxorubicin or epirubicin plus cyclophosphamide. After surgery, patients will continue adjuvant pembrolizumab for nine cycles or until cancer recurrence or unacceptable side effects occur. Each participant will undergo a 68Ga-FAPI-46 PET/CT scan before starting treatment, performed on the same machine as the 18F-FDG PET/CT scan and within 14 days prior to therapy. Throughout the study, researchers will monitor participants using scans and tissue analysis to assess histological response to treatment. They will measure the prediction accuracy through the area under the ROC curve at six months. Patient compliance, informed consent, and health insurance coverage are required for participation. Safety and treatment response will be carefully followed during and after the therapy period.

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 the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

This research aims to evaluate the effects of povorcitinib on reducing itch and improving skin lesions in adults with prurigo nodularis, a chronic skin condition characterized by itchy nodules. The study is a Phase 3 trial designed to assess the safety and efficacy of this treatment compared to a placebo in participants aged 18 to 75 years with a confirmed diagnosis of prurigo nodularis lasting at least three months. Participants will receive either oral povorcitinib tablets or placebo tablets as part of the randomized, double-blind study. Key eligibility includes having significant itch severity and at least 20 pruriginous lesions on multiple body regions. The study monitors the treatment effects over 24 weeks, focusing on improvements in itch intensity and skin lesion severity. During the study, participants will be closely monitored for changes in their itch scores and skin condition. Researchers will assess the proportion of participants achieving specified improvements by Week 24. Safety and tolerability will also be evaluated throughout the trial. Participants will undergo regular assessments including clinical evaluations, laboratory tests, and adherence monitoring to track progress and any side effects over the course of the study.

Researchers are evaluating the medicine spesolimab to see if it helps adults with ulcerative pyoderma gangrenosum (PG), a skin condition that causes ulcers. This Phase 3 trial focuses on whether spesolimab can lead to complete closure of PG ulcers. Adults with at least one ulcer measuring between 5 cm² and 80 cm² are eligible to participate. The study is conducted in two parts, each with different randomization and treatment rules. Participants receive either spesolimab or a placebo through vein infusions every four weeks. In Part 1, participants are randomly assigned with a 2 in 3 chance to receive spesolimab while also taking corticosteroids by mouth for 8 weeks. In Part 2, those without open ulcers are again randomized to spesolimab or placebo, while those with open ulcers receive spesolimab. The study treatment is carefully controlled and blinded so neither participants nor doctors know who receives the medicine or placebo. Participants will visit the study site about 20 times over 1.5 years. At each visit, doctors check the skin ulcers and overall health, monitoring for any side effects. The main outcome measured is whether the target PG ulcer achieves complete closure by Week 26, confirmed at least 2 weeks later. This long-term monitoring helps researchers understand the safety and effectiveness of spesolimab for treating PG ulcers.

Researchers are studying an experimental drug called linvoseltamab in adults newly diagnosed with symptomatic multiple myeloma who have not yet received treatment. This includes participants who are eligible or ineligible for high dose chemotherapy with autologous stem cell transplantation. The study aims to evaluate the safety, tolerability, and effectiveness of linvoseltamab as an initial treatment for this condition, including understanding possible side effects, optimal dosing, and how well the drug works to improve disease status over time. Linvoseltamab is given by intravenous infusion. The study has multiple phases: Phase 1 Parts A and B focus on identifying side effects and establishing the dosing regimen, while Phase 1 Part C studies side effects with different initial doses. Phase 2 enrolls more participants to continue assessing side effects and the drug's activity in shrinking tumors. The study also examines the effects of treatment before and after transplantation, levels of linvoseltamab in the blood, and whether the body produces antibodies against the drug. Participants will be closely monitored through various assessments including tracking adverse events up to 90 days after the last dose, and measuring responses such as very good partial response and minimal residual disease status for up to five years. Researchers will evaluate safety, tolerability, and treatment effectiveness over time, collecting data through clinical exams, laboratory tests, and response criteria established by the International Myeloma Working Group.

Researchers are evaluating the safety and effectiveness of brivekimig in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition. This Phase 2b, global, multi-center study is designed as a randomized, double-blind, placebo-controlled trial that tests different doses of brivekimig. The study aims to understand how well brivekimig works compared to a placebo in improving HS symptoms and to find the best dose. Participants will receive either brivekimig or a placebo as a subcutaneous injection. The study includes a dose-ranging phase followed by a maintenance period. The total duration of treatment in the randomized phase can last up to approximately 48 weeks. For those not entering the long-term extension, the study duration will be about 60 weeks, and for those transitioning to the long-term extension, it will be about 52 weeks. During the study, participants will be monitored regularly to assess their response to treatment, including the percentage achieving a clinical response called HiSCR75 by Week 16. Researchers will evaluate safety and efficacy through clinical assessments and follow participants throughout the study period. The total involvement per participant lasts up to around 60 weeks depending on extension study participation.

Researchers are evaluating methods to measure calcifications in native coronary arteries, which are important in heart disease. This non-randomized pilot study compares two imaging techniques: the 3DStent tool using rotational angiography and intracoronary intravascular ultrasound (IVUS). The goal is to assess how well each method quantifies coronary calcifications in patients with calcified coronary lesions. The study uses the 3DStent imaging technique performed with 200° rotational angiography at 30 frames per second while an angioplasty balloon is deflated in the target lesion before or after angioplasty. IVUS imaging is done using an Opticross™ catheter with a slow withdrawal speed and intracoronary nitrate injection. Both imaging methods are applied to the same lesions to compare their measurements. Participants are patients with angiographically calcified coronary lesions who can have the IVUS catheter pass through the lesion. Researchers measure the extent of calcification in degrees using 3DStent and IVUS on the first day of the study. Participants give informed consent and are monitored for safety and data collection. The study includes patients aged 18 and older and involves assessment of coronary lesions using these imaging techniques.

Researchers are studying chronic myelomonocytic leukemia, a type of leukemia, by collecting biological samples and associated anonymized data. This non-interventional, prospective study aims to better understand the disease's development and progression over time, with follow-up averaging 15 years. The study includes patients at any stage of the disease, whether or not they are receiving treatment. During the study, blood samples will be collected as part of routine medical assessments or clinical trials. Standard samples include two 10 mL EDTA tubes, with an additional 10 mL dry tube for initial assessments. Depending on the research needs, some tubes may be replaced with heparinized or citrated tubes. Bone marrow samples will also be taken during scheduled myelograms, and in rare cases, tissue samples may be collected during surgical procedures with surgeon consultation. Participants will be involved through their routine medical care, with samples collected during scheduled assessments. Researchers will monitor the disease by analyzing these samples and associated data to understand the disease's pathophysiology. The study requires signed consent and allows participation regardless of disease stage or treatment status. The average study duration is about 15 years, allowing long-term observation and understanding of chronic myelomonocytic leukemia.