Suwon

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 safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that attack cancer while minimizing stimulation of cells that suppress immunity. This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-escalation and dose-expansion parts for both monotherapy and combination therapy with pembrolizumab. MDNA11 is given intravenously every two weeks with doses ranging from 0.003 to 0.6 mg/kg for monotherapy, while dose ranges for combination therapy are also evaluated. Treatment continues until progression, withdrawal, or loss to follow-up, with tumor assessments by CT or MRI every 8 weeks. Participants will undergo regular imaging scans every 8 weeks to monitor tumor response and safety assessments throughout the 24-month study. Researchers will track recommended doses for expansion, treatment-related adverse events, and overall safety. The study involves up to 115 patients across multiple sites and includes long-term monitoring for up to 24 months.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

This research aims to understand how many children develop Crohn's disease (CD) and ulcerative colitis (UC) each year and how many are living with these conditions. It looks at differences in these numbers by age groups. The study also examines how children of different ages receive treatment over time and how their treatment changes as they grow. Additionally, it evaluates how often children use healthcare services and the costs associated with their care over several years. CD and UC are long-term diseases that cause inflammation and ulcers in the intestines, which are part of the digestive system. The study includes children under 18 years old diagnosed with either CD or UC. It gathers data from medical claims showing outpatient or inpatient diagnosis codes and records of prescriptions for common pediatric IBD medications like 5-aminosalicylic acids, exclusive enteral nutrition, corticosteroids, immunomodulators, or biologic drugs. The study tracks these children from 2012 to 2023, following their treatment patterns and healthcare use over time. Participants' information is collected from diagnosis and treatment records, including hospital visits, emergency visits, surgeries, and medication use. The study measures outcomes such as disease incidence and prevalence by age group, treatment types and changes, persistence with biologic drugs, healthcare visits, hospitalizations, surgeries, and related medical costs. This data is analyzed over up to 12 years for incidence and prevalence and up to 13 years for treatment and healthcare use, providing a long-term view of pediatric inflammatory bowel diseases in Korea.

Researchers are evaluating VVD-130037, a new investigational drug, in people with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037 alone and combined with chemotherapy drugs docetaxel or paclitaxel, or with the immunotherapy drug pembrolizumab. The study focuses on participants whose cancers have progressed despite previous standard treatments and includes specific groups such as those with squamous non-small cell lung cancer or head and neck squamous cell carcinoma. The study consists of two parts: a dose escalation phase where participants receive VVD-130037 alone or in combination with docetaxel, paclitaxel, or pembrolizumab to determine safe dosage and observe dose-limiting toxicities. Cycle lengths are 21 days for single agent and docetaxel/pembrolizumab combinations and 28 days for the paclitaxel combination. The dose expansion phase involves further evaluation of safety, adverse events, serious adverse events, and laboratory abnormalities over up to approximately four years. Participants will undergo evaluations including tumor measurements based on RECIST criteria, performance status checks, and organ function tests. Safety is closely monitored during the early dose-limiting toxicity periods and throughout the study. Researchers will collect data on side effects, lab results, and overall clinical status to understand how the treatments affect participants over time. The study includes regular follow-up visits and assessments to ensure participant safety and gather comprehensive treatment information.

Researchers are evaluating ALN-CFB, an experimental small interfering RNA drug, in adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) who continue to have anemia despite treatment with a complement component C5 inhibitor. This randomized, double-blind, placebo-controlled Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ALN-CFB. The study also investigates the side effects of ALN-CFB and its impact on Complement Factor B protein levels in the blood. Participants will receive either ALN-CFB or a placebo, both administered according to the study protocol. The study includes an initial treatment period with dosing as defined by the protocol. Details about additional study parts will be described after analyzing data from the first part. The placebo is designed to look like the study drug but contains no active medication. During the study, participants will be closely monitored for treatment-emergent adverse events and their severity over a period of up to 365 days. Researchers will also measure blood levels of ALN-CFB and Complement Factor B. The total duration of participant involvement and further assessments will be guided by the protocol amendments following initial data analysis.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.