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KRAS変異固形腫瘍患者における汎KRAS阻害剤LY4066434の研究

募集中NCT06607185第1相

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

対象疾患:
Advanced Solid TumorColorectal CancerMetastatic Solid TumorNon-small Cell Lung CancerPancreatic Ductal Adenocarcinoma

進行性消化器がん、胆道がん、または膵臓がんのホモ接合性メチルチオアデノシンホスホリラーゼ(MTAP)欠失患者を対象としたAMG 193と他の治療法の併用を評価する試験(MTAPESTRY 103)

募集中NCT06360354第1相

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.

対象疾患:
進行した消化器がん、胆道がん、膵臓がん

慢性炎症性脱髄性多発根神経炎(CIDP)の成人患者におけるTAK-881とHYQVIAの比較試験

募集中NCT06747351第3相

The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP. The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks. Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.

対象疾患:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

非アルコール性脂肪性肝疾患に対するペマフィブラートの有効性と安全性

実施中(募集終了)NCT06623539第2相

This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.

対象疾患:
Non Alcoholic Fatty Liver Disease

尿路上皮がんの疑いのある個人における高容量尿DNA検査の前向き検証研究

募集中NCT06310759

Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.

対象疾患:
Urothelial Carcinoma

長期使用に関する特別薬剤使用結果調査(アバコパン)

募集中NCT06758271

The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

対象疾患:
Granulomatosis With Polyangiitis (GPA)Microscopic Polyangiitis (MPA)

進行性または転移性非扁平上皮非小細胞肺がん患者におけるABP 234とキイトルーダ®(ペンブロリズマブ)の比較試験

実施中(募集終了)NCT06311721第3相

The primary objective of this study is to compare the efficacy of ABP 234 with the pembrolizumab reference product (Keytruda®).

対象疾患:
Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

増悪リスクのあるコントロール不良喘息の成人におけるAZD8630の多用量投与の有効性と安全性を評価する用量範囲探索試験

実施中(募集終了)NCT06529419第2相

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

対象疾患:
Asthma

びまん性皮膚全身性強皮症患者におけるイアナルマブの評価を目的とした臨床試験

募集中NCT06470048第2相

The purpose of this study is to evaluate efficacy, safety and tolerability of s.c. ianalumab administered in participants with diffuse cutaneous systemic sclerosis relative to placebo

対象疾患:
Diffuse Cutaneous Systemic Sclerosis

免疫疾患におけるRAY121の第1b相長期継続試験(RAINBOW-LTE試験)

招待制NCT06723106第1相

This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

対象疾患:
Antiphospholipid Syndrome (APS)Behçet's Syndrome (BS)Bullous Pemphigoid (BP)Dermatomyositis (DM)Immune Thrombocytopenia (ITP)1

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

募集中NCT06544655第1相

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).

対象疾患:
Advanced Solid Tumors

選択された進行固形腫瘍患者を対象としたLY4170156の研究

募集中NCT06400472第1相

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

対象疾患:
Carcinoma, Non-Small-Cell LungColorectal NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsPancreatic Neoplasm2

進行固形腫瘍におけるM9466単独または併用療法(DDriver 501)

実施中(募集終了)NCT06421935第1相

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

対象疾患:
Advanced Solid Tumor

進行HER2発現胆道癌におけるT-DXdおよびリルベゴストミグとSoCを比較する第3相試験

募集中NCT06467357第3相

The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.

対象疾患:
胆道がん

進行性/転移性胃食道腺癌におけるサシツズマブ ティルモテカン(MK-2870)の評価試験(MK-2870-015)

実施中(募集終了)NCT06356311第3相

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

対象疾患:
胃食道がん

抗うつ薬を服用しているうつ病患者を対象に、BI 1569912の異なる用量を試験する研究

完了NCT06280235第2相

This study is open to adults between 18 and 65 with a type of depression (major depressive disorder) for whom previous treatments for depression did not work. The purpose of the study is to find out whether a medicine called BI 1569912 helps people with depression. Participants continue their standard therapy throughout the study. Participants are put into 4 groups by chance. 3 of the 4 groups take different doses of BI 1569912. 1 group takes placebo. Placebo tablets looks like BI 1569912 but do not contain any medicine. Participants take the tablets once a day for 6 weeks. Participants are in the study for about 2 to 4 and a half months. During this time, they visit the study site at least 6 times. At the visits, doctors ask participants about their symptoms. The participants answer questions about their depression symptoms. The results are compared between the groups. The doctors also regularly check the general health of participants.

対象疾患:
Depressive Disorder, Major

中等度から重度のアトピー性皮膚炎の青年および成人患者を対象としたロカチンリマブ自己投与試験

実施中(募集終了)NCT06224192第3相

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.

対象疾患:
アトピー性皮膚炎

TAK-279の安全性と、中等度から重度の活動性クローン病患者の腸の炎症を軽減できるかどうかに関する研究

募集中NCT06233461第2相

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.

対象疾患:
Crohn's Disease

鼻腔内コルチコステロイド治療を受けた慢性副鼻腔炎および鼻ポリープ患者におけるレブリキズマブ(LY3650150)の試験(CONTRAST-NP)

募集中NCT06338995第3相

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

対象疾患:
慢性副鼻腔炎(鼻ポリープを伴う)(CRSwNP)

代償性肝硬変を伴う原発性胆汁性胆管炎患者および肝硬変を伴わない患者における K-808 (ペマフィブラート) の薬物動態および安全性を評価する研究。

完了NCT06525311第1相

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

対象疾患:
Compensated CirrhosisPrimary Biliary Cholangitis