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中等度から重度の尋常性乾癬患者を対象としたJNJ-77242113の長期継続投与試験

完了NCT05364554第2相

The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.

対象疾患:
Plaque Psoriasis

神奈川県における静脈内および血管内治療登録

不明NCT05213533

The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.

対象疾患:
Acute Ischemic Stroke

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

補体阻害薬による治療を受けていない、または最近受けていない発作性夜間ヘモグロビン尿症(PNH)の成人患者におけるポゼリマブ+セムジシラン併用療法の安全性と有効性を評価する研究

募集中NCT05133531第3相

This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

対象疾患:
Paroxysmal Nocturnal Hemoglobinuria

瘻孔を伴う肛門周囲クローン病患者におけるグセルクマブの研究

実施中(募集終了)NCT05347095第3相

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

対象疾患:
瘻孔性クローン病肛囲クローン病

稀な上皮成長因子受容体(EGFR)またはヒト上皮成長因子受容体2(HER2)の活性化変異を含む進行性または転移性非小細胞肺癌(NSCLC)患者におけるフルモネルチニブの研究

実施中(募集終了)NCT05364073第1相

This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

対象疾患:
Advanced Non-Small Cell Lung CancerEGFR Exon 20 MutationsEGFR Uncommon Mutations, Including G719X and S768IHER2 Exon 20 MutationsMetastatic Non-Small Cell Lung Cancer1

過体重または肥満の東アジア人におけるセマグルチド錠の1日1回服用の効果を調査する研究

完了NCT05132088第3相

Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning. In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional. Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.

対象疾患:
Overweight and Obesity

中等度から重度のアトピー性皮膚炎におけるロカチンリマブの評価研究(ROCKET-IGNITE)

完了NCT05398445第3相

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

対象疾患:
Atopic Dermatitis

活動性特発性炎症性筋疾患患者におけるニポカリマブの研究

実施中(募集終了)NCT05379634第2相

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

対象疾患:
筋炎

基礎インスリン療法を初めて開始する2型糖尿病成人患者におけるインスリンエフシトラアルファ(LY3209590)とデグルデクの比較試験

完了NCT05362058第3相

The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.

対象疾患:
DiabetesType 2 Diabetes

EGFRmステージIA2-IA3非小細胞肺癌患者における腫瘍完全切除後のオシメルチニブの効果を評価する国際共同研究

実施中(募集終了)NCT05120349第3相

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

対象疾患:
Non-Small Cell Lung Cancer

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

シルタカブタゲンオートロイセルによる治療を受けた参加者を対象とした長期研究

募集中NCT05201781第4相

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

対象疾患:
Multiple Myeloma

筋萎縮性側索硬化症(ALS)患者におけるPTC857治療の効果を評価する研究

中止NCT05349721第2相

This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.

対象疾患:
Amyotrophic Lateral Sclerosis

掌蹠膿疱症(PPP)の日本人患者を対象としたアプレミラストの第3相ランダム化試験

完了NCT05174065第3相

The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP).

対象疾患:
Palmoplantar Pustulosis

慢性炎症性脱髄性多発神経炎(CIDP)の成人患者に対するニポカリマブの有効性および安全性試験

募集中NCT05327114第2/第3相

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

対象疾患:
多発性根神経炎、慢性炎症性脱髄性

GORE® CARDIOFORM 隔壁閉塞器に関する日本郵政による調査

実施中(募集終了)NCT05529901

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

対象疾患:
Cryptogenic StrokePFO - Patent Foramen OvaleStrokeTIA

インスリンイコデックとセマグルチドの配合剤である新しい週1回投与薬イコセマが、週1回投与のセマグルチドと比較して、2型糖尿病患者の血糖値をどの程度コントロールできるかを調査する研究(COMBINE 2)

完了NCT05259033第3相

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

対象疾患:
Diabetes Mellitus, Type 2

進行食道癌患者におけるペムブロリズマブ(MK-3475)および/または化学療法の有無による併用療法の研究(MK-3475-06A)

完了NCT05342636第1/第2相

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

対象疾患:
Esophageal Squamous Cell Carcinoma (ESCC)

上皮成長因子受容体(EGFR)変異非小細胞肺がんを含む進行または転移性固形腫瘍患者におけるアミバンタマブの試験

募集中NCT05498428第2相

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

対象疾患:
非小細胞肺癌