治験一覧
8,963 件中 1101〜1120 件を表示
統合失調症患者におけるブレクスピプラゾール週1回投与（QW）製剤の食事影響試験
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
CADASILに対するアドレノメデュリン
Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is the most common form of hereditary cerebral small vessel disease, with no proven disease-modifying treatments. Adrenomedullin, a vasoactive peptide, has angiogenic, vasodilation, anti-inflammatory, and anti-oxidative properties and could have triple sites of action on components of the neuro-glial-vascular unit consisting of vessels, microglia and oligodendrocytes or, more specifically, on the white matter oligovascular unit. The aim of the AMCAD trial is to assess the safety and efficacy of Adrenomedullin in CADASIL patients.
早期アルツハイマー病患者を対象としたLIPUS-Brainの重要な研究
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in patients with Early Alzheimer's Disease. The primary objective of the study is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.
胃がんおよび食道がんの進行患者におけるBI 3706674の異なる投与量に対する忍容性を検証する研究
This study is no longer open to new participants. It was a study in adults with advanced cancer in the stomach and oesophagus. This is a study for people for whom previous treatment was not successful or no treatment exists. In this study, BI 3706674 is given to humans for the first time. The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone. Another purpose is to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing. Participants take BI 3706674 as a tablet when starting treatment. Different doses of BI 3706674 are tested during this study. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
進行固形腫瘍患者を対象としたSTX-478の単剤療法および他の抗腫瘍剤との併用療法に関するヒト初回臨床試験
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
悪性固形腫瘍を有する日本人被験者におけるGEN1042の安全性試験
This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants. The main purpose is to assess the safety and tolerability of GEN1042 monotherapy or GEN1042 in combination in Japanese study participants with cancer.
中等度から重度のアトピー性皮膚炎（AD）の青年期患者を対象としたロカチンリマブ（AMG 451）の評価試験
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants.
実際の臨床現場における中等度から重度のクローン病（CD）の成人患者を対象に、ウパダシチニブの効果発現の速さと持続性を評価する研究。
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
局所進行性または転移性固形腫瘍患者におけるHER3-DXdの研究
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
全身性重症筋無力症（gMG）の試験参加者によるロザノリキシズマブの自己投与を評価する第3相オープンラベルクロスオーバー試験
The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.
中等度から重度のアトピー性皮膚炎患者を対象とした2つの試験薬（PF-07275315およびPF-07264660）の効果を調べる研究
The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis (AD). AD is a long- lasting itchy red rash, caused by a skin reaction. This study is seeking participants who: * are 18 years of age or more. * Were confirmed to have AD at least 6 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. In Stage 1 of the study, participants will receive either PF-07275315 or PF-07264660 or placebo. Stage 1 is complete. In Stage 2 of the study participants will receive either PF-07275315 or placebo. In Stage 3 of the study participants who have received anti-inflammatory proteins, will receive either PF-07275315 or placebo. In Stage 4 of the study participants will receive either PF-07264660 or placebo. A placebo does not have any medicine in it but looks just like the medicines being studied. PF-07275315 or PF-07264660 or placebo will be given as multiple shots in the clinic over the course of each Stage. The experiences of people receiving PF-07275315 or PF-07264660 will be compared to people who do not. This will help determine if PF-07275315 and PF-07264660 are safe and effective. Participants in Stages 1, 2 and 4 will be involved in this study for up to 40 weeks (10 months). Participants in Stage 3 will be involved in this study for up to 52 weeks (13 months).
進行期パーキンソン病の日本人成人患者におけるABBV-951皮下注入による疾患活動性および有害事象の変化を評価する観察研究
Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting. ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan. Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
門脈（肝臓に通じる主要血管）の高血圧と肝硬変を併発し、食道出血や腹部の体液貯留を呈する患者にアベンシグアトが有効かどうかを検証する研究
This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes. People can join the study if they have high blood pressure in the portal vein (main vessel going to the liver) and bleeding in the esophagus or fluid accumulation in the belly. The purpose of this study is to find out whether a medicine called avenciguat helps people with this condition. Participants are put into 2 groups by chance. One group takes avenciguat tablets and the other group takes placebo tablets. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants take a tablet twice a day for 8 weeks. Participants are in the study for 2 to 3 months. During this time, they visit the study site regularly. At 2 of the visits, the doctors check the pressure in the liver vein by inserting a catheter (a long thin tube) that gives information about pressure in the portal vein. The change in blood pressure is then compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
MTAP欠失を伴う進行性または転移性固形腫瘍の成人患者におけるS095035の単剤および併用療法
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.
DenCT肩骨質評価
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
SPECTRUM試験：アフリベルセプト8mgが新生血管性加齢黄斑変性症または糖尿病性黄斑浮腫による視力障害の治療にどの程度有効であるかを詳細に調べる観察研究
これは、主治医からアフリベルセプト8mgを既に処方されている方のみからデータを収集する観察研究です。 本研究では、新生血管性加齢黄斑変性症（nAMD）または糖尿病黄斑浮腫（DME）による視力障害のある成人のデータを収集し、研究します。 視力障害とは、日常生活に支障をきたす程度の視力低下を指します。nAMDは、異常な血管が増殖し、網膜の中心部である黄斑に血液または網膜液が漏れ出すことで視力低下を引き起こす眼疾患です。nAMDは、50歳以上の人の視力低下の主な原因です。DMEは糖尿病に関連する眼疾患です。DMEでは、損傷した血管からの液漏れにより黄斑が腫れ、視力障害を引き起こします。 アフリベルセプト8mgは、眼内に注射する薬剤です。この薬は、眼底の血管の異常な増殖と漏出を引き起こす血管内皮増殖因子（VEGF）と呼ばれるタンパク質を阻害することで効果を発揮します。 アフリベルセプト8mgは、PHOTON試験とPULSAR試験という2つの試験結果に基づき、nAMDおよびDMEによる視力障害の治療薬として承認申請されています。この試験は、承認取得後すぐに開始されます。現在、アフリベルセプト8mgに関する実臨床データはありません。 この試験の主な目的は、nAMDおよびDMEの患者におけるアフリベルセプト8mg注射剤の有効性に関するより多くの情報を収集することです。この試験には、nAMDまたはDMEの治療歴のない参加者と、過去に治療を受けた参加者が参加します。 研究者が収集する主な情報： 治療開始12ヶ月後の最高矯正視力（BCVA）と呼ばれる視力検査スコアの変化 データは2024年2月から2027年9月まで収集され、参加者1人あたり最大24ヶ月間にわたります。データは、診療記録および日常診療における定期診察時の患者への聞き取り調査によって収集されます。 研究者は、アフリベルセプト8mgの初回投与から観察期間終了まで、参加者を観察します。 本研究では、定期診察から得られた利用可能なデータのみを収集します。本研究の一環として、診察や検査は必要ありません。
反復性片頭痛を有する成人日本人患者における疾患活動性の変化を評価するための経口アトゲパント錠の研究
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
プラチナ製剤、エトポシド、デュルバルマブ併用療法後の進展期小細胞肺癌（ES-SCLC）の第一選択治療におけるタルラタマブとデュルバルマブの併用とデュルバルマブ単独の併用を比較する試験
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
変形性膝関節症（OA）の成人患者におけるGSK3858279の有効性と安全性を評価する用量探索試験
This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
健康な成人男性ボランティアにおけるSTN1012600点眼液の薬物動態学的研究
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.