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転移性去勢抵抗性前立腺癌患者におけるパスリタミグとドセタキセルの併用とドセタキセル単独の併用を比較する試験

募集中NCT07225946第3相

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

対象疾患:
去勢抵抗性前立腺腫瘍

アトピー性皮膚炎の小児および乳児を対象としたOPA-15406フォームの第3相試験

募集前NCT07184645第3相

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

対象疾患:
Atopic Dermatitis (AD)

クレオパトラ:トランスサイレチンアミロイド(ATTR)アミロイドーシスによる心不全患者におけるコラミツグ(NNC6019-0001)と呼ばれる薬剤による治療効果を調査する研究

募集中NCT07207811第3相

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

対象疾患:
トランスサイレチンアミロイド心筋症(ATTR CM)

代謝機能障害関連脂肪肝疾患の成人における多剤併用療法のマスタープロトコル(SYNERGY-Outcomes)

募集中NCT07165028第3相

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.

対象疾患:
Metabolic Dysfunction-Associated Steatotic Liver Disease

喫煙を止め、再発を避けたい成人を対象としたブレニパチドの研究

募集中NCT07223840第2相

This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period. .

対象疾患:
Smoking

薬剤耐性肺結核の治療におけるクアボデピスタット含有レジメンの研究

募集中NCT07209761第3相

This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.

対象疾患:
Pulmonary Tuberculosis

既治療進展期小細胞肺がん患者におけるサシツズマブ・ゴビテカンと標準治療の比較試験

募集中NCT06801834第3相

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).

対象疾患:
Extensive Stage Small Cell Lung Cancer (ES-SCLC)

乾癬患者を対象としたデュクラバシチニブとウステキヌマブの長期安全性比較試験(PRAGMATYK)

募集中NCT07116967第3相

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

対象疾患:
尋常性乾癬

進行固形腫瘍患者を対象としたDS5361bの研究

募集中NCT07182591第1相

この研究の目的は、進行性または転移性固形腫瘍の患者における DS5361b の単独療法およびペンブロリズマブとの併用療法の安全性、忍容性、予備的な有効性を評価し、MTD を決定することです。

対象疾患:
進行固形腫瘍

シトリン欠損症におけるマルチオミクス研究

実施中(募集終了)NCT06895746

Citrin deficiency (CD) is an underdiagnosed and understudied condition characterized by several distinct phenotypes: 1) neonatal intrahepatic cholestasis caused by citrin deficiency (NICCD), 2) the adaptation or silent period, 3) "failure to thrive and dyslipidemia" form of CD (FTTDCD), and 4) citrullinemia type II (CTLN2), with the latter representing the final and most severe form of the condition. There is currently no cure for CD and patients manage their symptoms with lifelong dietary intervention and regular checkups with their physicians. A major hurdle in developing effective treatments for CD is the lack of effective biomarkers that track well with disease severity or measure the effectiveness of therapeutics. The present study aims to identify robust circulating biomarkers of CD through analysis of blood samples from CD patients.

対象疾患:
Citrin Deficiency

中等度から重度の慢性閉塞性肺疾患患者におけるAZD6793の効果を調査する研究

募集中NCT07082738第2相

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

対象疾患:
慢性閉塞性肺疾患(COPD)

中等度から重度の尋常性乾癬におけるESK-001の長期安全性と有効性

募集中NCT06846541第3相

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.

対象疾患:
Moderate PsoriasisPlaque PsoriasisPsoriasisPsoriasis (PsO)Severe Psoriasis

急性精神病を呈する統合失調症の日本人成人患者におけるKarXTの有効性と安全性を評価する研究

募集中NCT06882785第3相

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

対象疾患:
統合失調症

肥満または過体重の腹圧性尿失禁女性被験者におけるオルフォルグリプロンの研究

募集中NCT07202884第3相

The GZPS master protocol will support two independent studies, J2A-MC-GZS1 and J2A-MC-GZS2. Each study will see how well and safely orforglipron works in adult female participants with stress urinary incontinence (SUI) who have obesity or overweight. SUI is leaking urine during movement or activity such as coughing or exercising. Participation in the study will last about 58 weeks from screening to safety follow-up.

対象疾患:
Urinary Incontinence,Stress

トリプルネガティブ乳がんに対するペムブロリズマブ+パクリタキセル+/-ベバシズマブ

募集中NCT06976944第2相

* Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis. * For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered. * Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse. * Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab. Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.

対象疾患:
Recurrent Triple-Negative Breast Cancer

MTAP欠失ホモ接合体を有する、治療歴のある進行性または転移性非小細胞肺癌(NSCLC)患者を対象としたBMS-986504の試験(MountainTAP-9)

募集中NCT06855771第2相

この研究の目的は、以前の治療で病勢進行したホモ接合型 MTAP 欠失を伴う進行性または転移性非小細胞肺癌 (NSCLC) の参加者における BMS-986504 単独療法の安全性と有効性を評価することです。

対象疾患:
非小細胞肺癌

KMT2Ar、NPM1m、またはHOX過剰発現に関連する他の遺伝子型を有する進行性血液悪性腫瘍患者におけるAZD3632単独療法または抗癌剤との併用療法の研究

募集中NCT07155226第1/第2相

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

対象疾患:
Acute Lymphoblastic LeukaemiaAcute Myeloid LeukaemiaHigher-risk Myelodysplastic Syndromes

高血圧および肥満または過体重の参加者におけるオルフォルグリプロン(LY3502970)のマスタープロトコル:(ATTAIN-高血圧スクリーニング)

募集中NCT06948422第3相

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.

対象疾患:
Hypertension

TheraSphere Japan 市販前調査

募集中NCT07377487該当なし

To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.

対象疾患:
肝腫瘍

成人における全膝関節置換術後の血栓予防におけるREGN7508とアピキサバンおよびエノキサパリンの比較

募集中NCT07015905第3相

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

対象疾患:
静脈血栓塞栓症(VTE)