治験一覧
8,963 件中 661〜680 件を表示
デュピルマブで効果不十分な中等度から重度のアトピー性皮膚炎の成人患者を対象としたウパダシチニブの試験
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib 15mg or dupilumab 300mg. Based on the participants response to upadacitinib 15mg, they may have their dose increased to upadacitinib 30mg after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 200 adult participants ages 18 to less than 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 130 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
未治療小細胞肺がん患者に対する化学療法との併用療法として開発中のBNT327の安全性と有効性
This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
慢性移植片対宿主病の初期治療としてのアキサチリマブとコルチコステロイドを評価する研究
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
原発性胆汁性胆管炎（PBC）の成人日本人患者を対象としたエラフィブラノールの研究
本研究の目的は、PBC患者における試験介入（エラフィブラノール）の安全性と有効性を明らかにすることです。本研究の参加者は、胆汁うっ滞性肝疾患（UDCA）の管理および治療に使用される薬剤に対する反応不十分または不耐容を呈するPBC確定診断患者です。 PBCは、肝臓の胆管の損傷を特徴とする緩徐進行性の疾患で、胆汁酸の蓄積がさらなる損傷を引き起こします。PBCにおける肝障害は、瘢痕化（肝硬変）につながる可能性があります。 PBCは複数の症状を伴う場合もあります。PBC患者の多くは肝移植を必要とする可能性があり、病気が進行して肝移植が行われない場合は死亡する可能性もあります。本研究では、すべての参加者にエラフィブラノール（試験介入）が毎日投与されます。 本研究の主な目的は、エラフィブラノールがアルカリホスファターゼ（ALP）および総ビリルビン値を低下させるかどうかを明らかにすることです。血中ALPおよびビリルビン値の高値は、肝疾患の兆候となる可能性があります。 本試験は4つの期間に分かれています。1つは、参加者が試験に参加できるかどうかを判断するためのスクリーニング期間（最長10週間）。もう1つは、すべての適格な参加者がエラフィブラノールを投与される治療期間（52週間）。もう1つは、治療終了（EOT）期間から日本でエラフィブラノールが市販されるまでの、期間が変動する治療延長期間（2～5年）。もう1つは、参加者の健康状態をモニタリングするフォローアップ期間（4週間）。 参加者は、採血、採尿、身体検査、臨床評価、心電図（ECG：心臓の電気的活動の記録）、超音波検査（皮膚にプローブを当てて膀胱、尿路、肝臓を観察する非侵襲的な検査）、そしてFibroscan®検査（肝臓の硬度を測定する検査）を受けます。また、質問票への記入も求められます。各参加者は最大約6年間この研究に参加する。
抗HER2療法により持続的奏効を達成したHER2陽性転移性乳がん患者に対するctDNAの個別化検出（HER2 CR）
Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer. The updated data of the CLEOPATRA trial showed significant Kaplan-Meier curves, suggesting the potential for a cure. However, the efficacy of maintenance therapy in long-term responders remains unexplored. This study will assess MRD in unresectable HER2-positive breast cancer cases with long-term response using the Signatera™ ctDNA assay, which could contribute to future treatment strategy development.
未治療の高リスク大細胞型B細胞リンパ腫患者におけるゴルカドミド＋R-CHOPとプラセボ＋R-CHOPの有効性と安全性を比較する試験
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
原発性進行または再発子宮内膜癌の日本人患者を対象とした、ドスタルリマブとカルボプラチン・パクリタキセルの併用療法に関する研究
The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer
切除可能非小細胞肺癌（NSCLC）の成人患者において、病理学的完全奏効（pCR）に達していないペムブロリズマブ（MK-2870）とサシツズマブ・ティルモテカン（MK-2870）の併用または非併用の有効性と安全性を評価する試験（MK-2870-019）
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
進行固形腫瘍患者におけるBMS-986484単独療法および併用療法の研究
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
既治療頭頸部扁平上皮癌患者におけるペトセムタマブと治験担当医推奨の単剤療法を比較評価する第3相試験
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
ONO-2017 試験：原発性全般強直間代発作のある日本人患者
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
継続的な試験治療と継続的な安全性モニタリングのためのロールオーバー試験
The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).
RSウイルス感染症のリスクが高い18～49歳の成人と60歳以上の高齢者を比較した、RSウイルス（RSV）ワクチンの免疫反応と安全性に関する研究
The aim of this study is to demonstrate the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for RSV disease, compared to older adults (OA) 60 YOA and above.
切除不能胆道癌患者を対象とした、化学療法後に病勢進行した線維芽細胞増殖因子受容体2（FGFR2）融合遺伝子陽性患者を対象としたタスフィゴの市販後観察研究
The primary purpose of this study is to investigate the safety of Tasfygo.
THAにおけるポリエチレン摩耗粒子の分析
Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.
日本における低リスク骨髄異形成症候群患者の実際の診療パターンと転帰
The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.
進行胃がんにおける有効性の予測。
With advances in chemotherapy for gastric cancer, it is important to identify patients who will respond effectively to specific therapies. This longitudinal study aimed to establish a liquid-biopsy assay that can predict response to ramucirumab plus paclitaxel therapy in patients with advanced gastric cancer.
PD-L1（プログラム細胞死リガンド1）発現率の高い非小細胞肺がん（NSCLC）患者における、ベルレストタグとドスタルリマブの併用療法とプラセボとペムブロリズマブの併用療法を比較した試験
The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.
KRAS/NRASおよびBRAF野生型の切除不能または転移性左側大腸癌患者における第一選択治療としてのアミバンタマブとmFOLFOX6またはFOLFIRIの併用とセツキシマブとmFOLFOX6またはFOLFIRIの併用を比較する試験
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
ANCA関連血管炎におけるアバコパンと減量グルココルチコイドの比較
The goal of this clinical trial is to learn if avacopan in combination with short-term (4 weeks) reduced-dose glucocorticoid and rituximab works to treat patients with newly-onset ANCA-associated vasculitis. It will also learn about the long-term safety of avacopan. The main questions it aims to answer are: Is avacopan in combination with short-term reduced-dose glucocorticoid and rituximab as effective as the combination of 20 week reduced-dose glucocorticoid and rituximab in the proportion of the patients achieving remission? Does avacopan lower the relapse rate compared to the 6 monthly rituximab maintenance therapy? What medical problems do participants have when taking long-term avacopan? Participants will: Be treated with avacopan in combination with short-term (until 4 weeks) reduced-dose glucocorticoid and rituximab (at 0 week) or reduced-dose glucocorticoid (until 20 weeks) and rituximab (at 0, 26, 52 and 78 weeks). Be assessed at 0, 4, 8, 16, 26, 52, 78 and 104 weeks regarding disease status (remission/relapse), disease activity by Birmingham Vasculitis Activity Score ver3, disease damage by Vasculitis Damage Index and adverse events. The primary endpoint is remission rates at 26 weeks.