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進行非小細胞肺がん患者を対象としたMGY825の研究

中止NCT05275868第1相

Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.

対象疾患:
Non-small Cell Lung Cancer

中等度から重度のアトピー性皮膚炎患者(生後6ヶ月から18歳未満)を対象としたレブリキズマブ(LY3650150)の試験

実施中(募集終了)NCT05559359第3相

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

対象疾患:
Atopic DermatitisEczema

局所進行直腸癌に対するSCRT+CAPOXとSCRT+CAPOXIRIのTNT

募集中NCT05646511第3相

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

対象疾患:
Locally Advanced Rectal Cancer

活動性ループス腎炎患者におけるセクキヌマブの有効性、安全性および忍容性に関する非盲検継続試験

中止NCT05232864第3相

The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).

対象疾患:
Lupus Nephritis

フォシーガ CKD 日本における製造販売後調査(PMS)

完了NCT05306210

To capture safety when Forxige is administrated to CKD patients in the real world setting

対象疾患:
Chronic Kidney Disease

非閉塞性肥大型心筋症におけるマバカムテンの研究

完了NCT05582395第3相

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

対象疾患:
Cardiomyopathy, Hypertrophic

活動性シェーグレン症候群患者におけるイアナルマブ(VAY736)の有効性と安全性を評価する3群間試験

実施中(募集終了)NCT05349214第3相

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

対象疾患:
Sjogren Syndrome

肝移植後の同種移植片不全を予測するモデルの開発

不明NCT05289609

Prompt identification of allograft failure (AF) is highly desirable to address patients to liver retransplantation, in order to maximize results and preserve patients safety. Recently, sophisticated kinetic models became available, offering the possibility to predict 90-day AF with unprecedented accuracy, by computing data from the first 10 days after liver transplant (LT). The growing utilization of extended criteria and cardiac death donors stimulates the transplant community to further refine such predictive models and validate them on a larger scale population of patients across the nations. This study aims to develop new algorithms for the timely prediction of AF at 90 and 365 days using a prospective international cohort from high-volume centers, to validate them on a large retrospective cohort, to identify the best time for retransplantation, to stratify the risk of AF according to the graft type (i.e. DBD, ECD, DCD, LD), to weigh the effect of risk-mitigation strategies, and to assess the correlation with post-LT morbidity and mortality.

対象疾患:
Liver Transplant Disorder

変形性膝関節症の成人患者におけるRTX-GRT7039の有効性と安全性

完了NCT05248386第3相

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

対象疾患:
Osteoarthritis

進行性腫瘍患者を対象としたBMS-986406の単剤療法および併用療法に関する研究

完了NCT05298592第1相

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.

対象疾患:
Advanced Cancer

PF-07265028 進行性または転移性固形腫瘍における単剤およびササンリマブとの併用

中止NCT05233436第1相

The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab. The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development. The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose. It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.

対象疾患:
進行固形腫瘍胃がん胃食道接合部がん頭頸部扁平上皮癌非小細胞肺がん1

進展期小細胞肺癌(ES-SCLC)患者におけるカルボプラチン、エトポシド、PD-L1阻害剤との併用による第一選択薬タルラタマブ

実施中(募集終了)NCT05361395第1相

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

対象疾患:
Extensive Stage Small Cell Lung Cancer

胃がん、胃食道接合部がん、または膵臓がんの成人患者におけるASP2138単独投与または他のがん治療との併用投与に関する研究

募集中NCT05365581第1相

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 * ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). * Different small groups are given lower to higher doses of ASAP2138. * ASP2138 is either given by itself, or given with 1 of 3 standard treatments: * Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) * Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) * ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 * ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. * People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. * This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. * The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.

対象疾患:
胃腺癌胃食道接合部(GEJ)腺癌膵腺癌

GIST患者におけるピミテスピブとイマチニブの併用試験(CHAPTER-GIST-101)

実施中(募集終了)NCT05245968第1相

This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.

対象疾患:
Gastrointestinal Stromal Tumors

未治療進行・再発胃癌患者におけるニボルマブと化学療法の併用療法の有効性と安全性に関する研究

実施中(募集終了)NCT05334719

The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.

対象疾患:
Stomach Neoplasms

VN-0200の用量探索試験

完了NCT05547087第2相

This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

対象疾患:
Respiratory Syncytial Virus Infections

呼吸器疾患における呼気終末二酸化炭素濃度の評価

不明NCT05188976

The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

対象疾患:
Respiratory Disease

ンゲンラ皮下注射剤特別調査

実施中(募集終了)NCT05602766

The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice. Registration criteria of this study are the patients who: * Have GHD without epiphyseal closure and receiving Ngenla for the first time. * Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla. All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use. Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.

対象疾患:
Growth Hormone Deficiency Without Epiphyseal Closure

セマグルチドとNNC0480-0389の併用が2型糖尿病患者にどれほど有効であるかを検証した研究

完了NCT05144984第2相

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes. The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies. Participants will either get: Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine). NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance. Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo. Participant must inject the study medicines themself into the stomach, thigh, or upper arm. The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study. Women can only take part in the study if they are not able to become pregnant

対象疾患:
Diabetes Mellitus, Type 2

nAMD患者を対象としたRGX-314遺伝子治療のピボタル2試験

募集中NCT05407636第3相

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

対象疾患:
AMDCNVWet Age-related Macular DegenerationWetAMDnAMD1