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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回投与のインスリン・イコデックと比較して、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

完了NCT05352815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 insulin icodec 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 insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants 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 21 clinic visits, 31 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. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.

対象疾患:
Diabetes Mellitus, Type 2

進行性骨化性線維異形成症(FOP)の成人患者を対象に、ガレトスマブとプラセボを静脈内(IV)投与した場合の安全性、忍容性、有効性を評価する試験

実施中(募集終了)NCT05394116第3相

This study is researching an experimental drug called garetosmab. The study is focused on adult patients with fibrodysplasia ossificans progressiva (FOP). The aim of the study is to see how safe and effective the study drug is in patients with FOP. The study is looking at several other research questions, including: * What side effects may happen from receiving 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 drug less effective or could lead to side effects)

対象疾患:
Fibrodysplasia Ossificans Progressiva

単純性尿路感染症(急性膀胱炎)の日本人女性患者におけるゲポチダシンの有効性と安全性を検討する試験

完了NCT05630833第3相

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 \[NCT04020341\] and 212390 \[NCT04187144\]).

対象疾患:
Urinary Tract Infections

急性骨髄性白血病(AML)の完全寛解期にある日本人患者における維持療法としての経口アザシチジン+ベストサポーティブケアとベストサポーティブケア単独の有効性と安全性を比較する試験

実施中(募集終了)NCT05197426第2相

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

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

肥満成人における罹患率および死亡率の減少に関するティルゼパタイド(LY3298176)の研究

実施中(募集終了)NCT05556512第3相

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

対象疾患:
ObesityOverweight

好酸球性食道炎患者におけるテゼペルマブの有効性と安全性

実施中(募集終了)NCT05583227第3相

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

対象疾患:
Eosinophilic Esophagitis

中等度から重度のアトピー性皮膚炎患者(生後6ヶ月から18歳未満)を対象としたレブリキズマブ(LY3650150)の試験

実施中(募集終了)NCT05559359第3相

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).

対象疾患:
Atopic DermatitisEczema

Hot AXIOSシステムを用いたEPASSの臨床試験

完了NCT05644951該当なし

A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)

対象疾患:
Gastric Outlet Obstruction

増悪歴のある症状のある慢性閉塞性肺疾患におけるトゾラキマブの有効性と安全性

実施中(募集終了)NCT05166889第3相

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

対象疾患:
Chronic Obstructive Pulmonary Disease (COPD)

慢性心不全(HFpEF)の悪化患者を対象としたLY3540378の試験

中止NCT05592275第2相

The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction

対象疾患:
心不全駆出率が保たれた心不全

サイトメガロウイルス(CMV)感染症の日本人におけるマリバビルに関する研究

完了NCT05137717第3相

The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study. During the study, participants will visit their study clinic 18 times as a maximum.

対象疾患:
Cytomegalovirus (CMV)

自己免疫性脳炎患者を対象としたNPB-01の第III相臨床試験

不明NCT05177939第3相

To compare the efficacy and safety of NPB-01 in patients with autoimmune encephalitis refractory to steroid pulse therapy using steroid pulse therapy as a control.

対象疾患:
Autoimmune Encephalitis

変形性膝関節症の成人患者におけるRTX-GRT7039の有効性と安全性

完了NCT05248386第3相

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

対象疾患:
Osteoarthritis

再発性または難治性の末梢性T細胞リンパ腫および皮膚T細胞リンパ腫患者を対象としたレミトロの臨床試験(全症例研究)

完了NCT05137847

The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).

対象疾患:
Lymphoma, T-cell, CutaneousLymphoma, T-cell, Peripheral

2歳以上12歳未満のコントロール不良慢性特発性蕁麻疹(CSU)患者を対象としたデュピルマブの薬物動態および安全性を調査する試験(LIBERTY-CSU CUPIDKids)

完了NCT05526521第3相

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

対象疾患:
Chronic Spontaneous Urticaria

進行非小細胞肺がん患者を対象としたMGY825の研究

中止NCT05275868第1相

Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer.

対象疾患:
Non-small Cell Lung Cancer

転移性大腸癌後期患者におけるニボルマブ・レラトリマブ固定用量併用療法とレゴラフェニブまたはTAS-102との比較試験

中止NCT05328908第3相

The purpose of this study is to evaluate relatlimab in combination with nivolumab, administered as a fixed-dose combination (nivolumab-relatlimab FDC, also referred to as BMS-986213) for the treatment of non-microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC) participants who failed at least 1 but no more than 4 prior lines of therapy for metastatic disease.

対象疾患:
Colorectal Neoplasms

SCLE、DLE、および/またはSLE患者を対象としたM5049を用いたWillow LTE試験(WILLOW LTE)

実施中(募集終了)NCT05540327第2相

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569\_0003 \[NCT05162586\]).

対象疾患:
Systemic Lupus Erythematosus

進行固形腫瘍患者における静脈内QEQ278の安全性と忍容性を調査する研究

中止NCT05462873第1相

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

対象疾患:
非小細胞肺癌腎細胞癌食道扁平上皮癌頭頸部扁平上皮癌