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標準リスク患者におけるCOVID-19に対するプロテアーゼ阻害の評価(EPIC-SR)。

中止NCT05011513第2/第3相

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

対象疾患:
COVID-19

ノバフェロンのCOVID-19治療薬治験(NCTT-005)

不明NCT04708158第3相

A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients

対象疾患:
Covid19

プログラム細胞死1リガンド1(PD-L1)陽性転移性非小細胞肺癌に対するペムブロリズマブ/ビボストリマブ(MK-7684A)の配合剤とペムブロリズマブ(MK-3475)単独療法の比較(MK-7684A-003、KEYVIBE-003)

完了NCT04738487第3相

Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive. * Metastatic means cancer that has spread to other parts of the body. * PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system. The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.

対象疾患:
肺腫瘍非小細胞肺癌

健康な日本人成人男性被験者におけるASP5354の安全性、忍容性、および薬物動態を評価するための研究

完了NCT04878471第1相

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.

対象疾患:
Healthy Volunteers

日本の2型糖尿病患者における経口セマグルチドの作用機序を検証する研究(地域臨床実践の一環として)

完了NCT04878393

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels, and to get side-effects information. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

対象疾患:
Diabetes Mellitus, Type 2

IgA腎症におけるヒト抗CD38抗体フェルザルタマブ(MOR202)の有効性と安全性を評価する臨床試験

完了NCT05065970第2相

Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN

対象疾患:
Immunoglobulin A (IgA) Nephropathy

胃癌治療歴のある患者におけるツサミタマブ・ラブタンシン(SAR408701)とラムシルマブの併用

中止NCT05071053第2相

Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma Secondary Objectives: * To assess safety and tolerability * To assess durability of response (DOR) * To assess progression-free survival (PFS) * To assess the disease control rate (DCR) * To assess the pharmacokinetics (PK) * To assess the immunogenicity

対象疾患:
Adenocarcinoma GastricGastrooesophageal Cancer

デュシェンヌ型筋ジストロフィー(DMD)患者におけるデランディストロゲンモキセパルボベック(SRP-9001)の安全性と有効性を評価する遺伝子導入療法研究

完了NCT05096221第3相

The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study. The participants who are randomized to the placebo arm will have an opportunity for treatment with gene transfer therapy at the beginning of the second year.

対象疾患:
Duchenne Muscular Dystrophy

進行性腎細胞癌および卵巣腫瘍患者におけるDS-6000aの研究

実施中(募集終了)NCT04707248第1相

This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of R-DXd that can be given safely to participants, assess the adverse events of R-DXd, and evaluate the effectiveness of R-DXd.

対象疾患:
Ovarian TumorRenal Cell Carcinoma

オシメルチニブ治療無効後の上皮成長因子受容体(EGFR)変異陽性局所進行性または転移性非小細胞肺癌患者におけるプラチナ製剤ベースの化学療法とアミバンタマブおよびラゼルチニブの併用とプラチナ製剤ベースの化学療法との比較試験

実施中(募集終了)NCT04988295第3相

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

対象疾患:
非小細胞肺癌

健康な日本人および中国人被験者を対象としたJNJ-77242113の研究

完了NCT05062200第1相

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR) tablet formulation in healthy Japanese participants and after single oral dose administration as an IR tablet formulation in healthy Chinese participants; and as a delayed release (DR) tablet formulation in healthy Japanese participants.

対象疾患:
Healthy

局所進行切除不能または転移性ホルモン受容体陽性HER2陰性乳癌に対するベバシズマブとパクリタキセルの併用療法に関するアテゾリズマブとの第III相試験

実施中(募集終了)NCT04732598第3相

JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive HER2 negative metastatic breast cancer.

対象疾患:
Breast Cancer

RET遺伝子異常を伴う進行固形腫瘍患者におけるRET阻害剤TAS0953/HM06の研究

募集中NCT04683250第1/第2相

Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.

対象疾患:
RET-altered Non Small Cell Lung CancerRET-altered Solid Tumors

進行性中皮腫およびその他の固形腫瘍患者を対象としたIAG933の第I相試験

実施中(募集終了)NCT04857372第1相

The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.

対象疾患:
Mesothelioma

未治療のTP53変異急性骨髄性白血病患者におけるアザシチジンとマグロリマブの併用と、医師の選択によるアザシチジンとベネトクラックスの併用または強化化学療法の併用との比較試験

中止NCT04778397第3相

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

対象疾患:
Acute Myeloid Leukemia

軽度から中等度の潰瘍性大腸炎におけるアミセリモド(MT-1303)の有効性と安全性を評価する研究

完了NCT04857112第2相

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

対象疾患:
Ulcerative Colitis

リチフィリマブ(BIIB059)注射剤の安全性と、全身性エリテマトーデスの成人患者の症状改善効果を検証する研究

実施中(募集終了)NCT04961567第3相

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: \- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), the British Isles Lupus Activity Group-2004 index (BILAG-2004), and the BILAG-BASED Combined Lupus Assessment (BICLA), among others. Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. * All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. * Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

対象疾患:
Lupus Erythematosus, Systemic

健康な日本人ボランティアを対象とした安全性および薬物動態試験

完了NCT05032560第1相

The study consists of Part A, a randomized double-blind, single-ascending-dose study, and Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in healthy Japanese volunteers.

対象疾患:
Healthy Volunteers

転移性大腸癌患者を対象としたレンバチニブ(MK-7902/E7080)とペムブロリズマブ(MK-3475)の併用療法と標準治療との比較試験(MK-7902-017/E7080-G000-325/LEAP-017)

完了NCT04776148第3相

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

対象疾患:
大腸腫瘍

日本人健康成人および高齢者を対象としたDS-5670a(COVID-19ワクチン)の研究

完了NCT04821674第1/第2相

This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.

対象疾患:
Covid19