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中等度から重度の潰瘍性大腸炎またはクローン病におけるTEV-48574の効果を検証する研究

完了NCT05499130第2相

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14. Secondary objectives: * To evaluate the efficacy of 2 different doses of TEV-48574 as assessed by multiple standard measures * To evaluate the safety and tolerability of 2 different doses of TEV-48574 * To evaluate the immunogenicity of 2 different dioses of TEV-48574 The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

対象疾患:
Colitis, UlcerativeCrohn Disease

2種類の異なる用量のアベンシグアトが、肝硬変および門脈(肝臓につながる主要な血管)の高血圧患者に効果があるかどうかを検証する研究

中止NCT05161481第2相

This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this condition. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of Avenciguat as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like Avenciguat tablets but do not contain any medicine. Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患:
Hypertension, Portal

中等度から重度の尋常性乾癬患者を対象としたJNJ-77242113の研究

完了NCT05223868第2相

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

対象疾患:
尋常性乾癬

再発性急性骨髄性白血病(AML)の小児におけるベネトクラックス

募集中NCT05183035第3相

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

対象疾患:
Acute Myeloid Leukemia

重症化リスクの高いCOVID-19患者を対象としたオベルデシビルに関する研究

中止NCT05603143第3相

The goal of this clinical study is to test how well the study drug, obeldesivir (GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

対象疾患:
COVID-19

健康な日本人男性被験者を対象とした、ブリバラセタム錠とドライシロップの生物学的同等性を評価する研究

完了NCT05315947第1相

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.

対象疾患:
Healthy Study Participants

進行固形腫瘍患者を対象としたGSK4381562の初めてのヒト臨床試験

募集中NCT05277051第1相

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

対象疾患:
Neoplasms

日本人を対象とした片頭痛予防のためのリメゲパントの有効性および安全性試験(日本のみ)

完了NCT05399485第3相

This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

対象疾患:
Migraine

健康な成人および腎機能が低下した成人におけるASP5354の身体への影響に関する研究

完了NCT05495581第1相

The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. ASP5354 is a potential new medical dye to help surgeons clearly see the ureter during surgery. ASP5354 is injected into the body and is detected by a type of camera called near infrared fluoroscopy, or NIR-F for short. Together they show live images of the ureter during surgery. Before ASP5354 is available as a medical dye, the researchers need to understand how it affects the body. In this study, the researchers will check how ASP5354 affects the body in adults up to 75 years old. The main aim is to learn how ASP5354 is processed by the body in people whose kidneys do not work well compared to healthy people. There will be 4 groups of people with different levels of how well their kidneys work. This study will include a 3-night stay in a clinical research unit. People will be admitted to the clinic the day before they receive the ASP5354 injection. The study doctor will take their medical history. People will have an ECG to measure their heart rhythm, a medical examination, and will have their vital signs checked (pulse rate, body temperature and blood pressure). They will also give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. People will need to fast for several hours before receiving the injection. The next day, people will receive 1 injection of ASP5354. They will continue to fast for a few hours afterwards. They will have an ECG and will have their vital signs checked. They will also give blood and urine samples for laboratory tests and the study doctors will check for medical problems. During the next 2 days, people will give more blood and urine samples and the study doctors will check for medical problems. On the last day, people will also have their vital signs checked. If there are no medical problems on the last day, people can return home. People will return to the clinic about 1 week later for a final check-up. They will have an ECG, a medical examination and have their vital signs checked. They will give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. The study doctors will also check for medical problems.

対象疾患:
Healthy VolunteersRenal Impairment

好酸球性胃腸炎の成人および青年日本人患者を対象としたCC-93538の有効性と安全性を評価する試験

完了NCT05214768第3相

The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.

対象疾患:
Eosinophilic Gastroenteritis

進行固形腫瘍における抗CEACAM5 ADC M9140(PROCEADE-CRC-01)

募集中NCT05464030第1相

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2). Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program

対象疾患:
Colorectal Cancer

近位胃癌および胃食道接合部癌に対する低侵襲近位胃切除術と全胃切除術の比較に関する太平洋横断多施設共同研究

募集中NCT05205343

MIPG の患者の症状と MITG の患者の症状を比較します。

対象疾患:
胃食道がん胃瘻

RANS。重症好酸球性喘息および鼻ポリープ患者を対象とした研究。

完了NCT05180357

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

対象疾患:
Nasal PolypsSevere Eosinophilic Asthma

レゴラフェニブとニボルマブ+化学療法の臨床試験

実施中(募集終了)NCT05394740第1/第2相

This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.

対象疾患:
Esophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

上皮成長因子受容体(EGFR)エクソン20挿入変異を有する局所進行性または転移性非小細胞肺癌(NSCLC)患者に対するフルモネルチニブとプラチナ製剤ベースの化学療法の比較研究(FURVENT)

実施中(募集終了)NCT05607550第3相

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.

対象疾患:
Advanced Non-Small Cell Lung CancerEGFR Exon 20 MutationsMetastatic Non-Small Cell Lung Cancer

全身性強皮症患者におけるネモリズマブの有効性と安全性を評価するオープンラベル第2相試験

完了NCT05214794第2相

To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

対象疾患:
全身性強皮症

好酸球増多症候群患者におけるデペモキマブの有効性および安全性試験

募集中NCT05334368第3相

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

対象疾患:
Hypereosinophilic Syndrome

治療抵抗性高血圧患者におけるXXB750の有効性、安全性、忍容性および用量設定試験。

完了NCT05562934第2相

The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

対象疾患:
Resistant Hypertension

潰瘍性大腸炎(UC)またはクローン病(CD)の小児におけるベドリズマブの研究

募集中NCT05442567第3相

The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

対象疾患:
Crohn's DiseaseUlcerative Colitis

糖尿病性腎症患者におけるトホグリフロジンとメトホルミン塩酸塩の尿中アルブミン・クレアチニン比(UACR)への影響の比較(TRUTH-DKD試験)

募集中NCT05469659第2相

This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).

対象疾患:
MetforminSGLT2-InhibitorsT2DM (Type 2 Diabetes Mellitus)