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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

代謝機能障害関連脂肪肝疾患(MASLD)患者を対象としたLY3849891の単回漸増および反復投与試験

実施中(募集終了)NCT05395481第1相

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on MASLD and assessment of resolution of liver fibroinflammation. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 visits in parts A and B.

対象疾患:
Metabolic Dysfunction-Associated Steatohepatitis (MASH)Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

活動性ループス腎炎患者におけるセクキヌマブの有効性、安全性および忍容性に関する非盲検継続試験

中止NCT05232864第3相

The purpose of this open-label extension study was to provide treatment with secukinumab for subjects who completed core study treatment in Study CAIN457Q12301 (NCT04181762), and to obtain further data on long-term efficacy, safety and tolerability of secukinunab in patients with active lupus nephritis (LN).

対象疾患:
Lupus Nephritis

転移性非小細胞肺癌患者を対象とした、ペムブロリズマブ/ビボストリマブ配合剤(MK-7684A)と化学療法の併用とペムブロリズマブ+化学療法の併用を比較する試験(MK-7684A-007/KEYVIBE-007)

完了NCT05226598第3相

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

対象疾患:
転移性非小細胞肺がん

HER2陰性で切除不能な進行性または再発性胃癌(食道胃接合部癌を含む)の化学療法未治療患者を対象に、ONO-4538とイピリムマブおよび化学療法を併用した場合の有効性および安全性を評価する研究

実施中(募集終了)NCT05144854第3相

This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

対象疾患:
Gastric Cancer

TSCに伴う皮膚病変を有する患者におけるNPC-12Yゲルの臨床試験

完了NCT05495425第3相

The purpose of this study is to investigate the efficacy and safety of NPC-12Y gel compared with placebo for skin lesions associated with tuberous sclerosis.

対象疾患:
Tuberous Sclerosis Complex

リポタンパク質(a) [Lp(a)] が上昇している参加者を対象としたLY3819469の研究

完了NCT05565742第2相

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.

対象疾患:
Lipoprotein Disorder

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

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

mRNA-3927-P101試験に以前登録された参加者におけるmRNA-3927の長期安全性と臨床活性を評価する試験

募集中NCT05130437第1/第2相

The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).

対象疾患:
Propionic Acidemia

癌、悪液質、GDF-15上昇患者におけるポンセグロマブの有効性と安全性に関する研究

完了NCT05546476第2相

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

対象疾患:
CachexiaColorectal CancerFatigueLoss of AppetiteNon-small Cell Lung Cancer1

原発性/特発性トリグリセリド沈着心筋血管症に関する登録研究

完了NCT05345223

The objective of this study is to construct a registry; in order to understand the onset status of triglyceride deposit cardiomyovasculopathy (TGCV) in Japan with patients' background and natural history of the disease, and to explore disease-specific prognostic factors.

対象疾患:
Triglyceride Deposit Cardiomyovasculopathy

小児のPsV、PsA、またはGPP患者におけるコセンティクスの安全性と有効性を評価するための特別な薬剤使用結果調査

完了NCT05215561

This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during the observation period (52 weeks after the start of treatment with this drug) in pediatric patients with psoriasis vulgaris, psoriatic arthritis, or pustular psoriasis who received this drug.

対象疾患:
Psoriasis VulgarisPsoriatic ArthritisPustular Psoriasis

H3 K27M変異びまん性神経膠腫に対する放射線療法後のONC201(ACTION試験)

募集中NCT05580562第3相

This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.

対象疾患:
GliomaH3 K27M

非閉塞性肥大型心筋症におけるマバカムテンの研究

完了NCT05582395第3相

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

対象疾患:
Cardiomyopathy, Hypertrophic

血液悪性腫瘍を有する日本人患者を対象とした、治験薬(マプリルパセプト(PF-07901801))に関する調査研究

完了NCT05567887第1相

The purpose of this clinical trial is to learn about how safe and tolerable is the study medicine (called maplirpacept (PF-07901801)) when taken for the treatment of lymphoma or multiple myeloma (a type of cancer that affects your body's infection-fighting cells, lymphocytes or plasma cell). This study is seeking participants who: * are 18 years of age or older * have worsening and difficult to manage type of lymphoma or multiple myeloma * Have adequately functioning organs * are not on long term use of steroids which are given either by mouth or as shots * have no major heart related disease etc. All participants in this study will receive maplirpacept (PF-07901801) as an IV infusion (given directly into a vein) at the study clinic every week. Participants will continue to receive maplirpacept (PF-07901801) until their progress of cancer worsens or the participants do not wish to take the study medicine. The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine maplirpacept (PF-07901801), is safe and can be given to Japanese people.

対象疾患:
LymphomaMultiple Myeloma

GIST患者におけるピミテスピブとイマチニブの併用試験(CHAPTER-GIST-101)

実施中(募集終了)NCT05245968第1相

This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.

対象疾患:
Gastrointestinal Stromal Tumors

慢性気管支炎の症状を伴う軽度から中等度のCOPD患者における、紙巻きタバコからTHSへの切り替えが疾患進行に及ぼす影響。

中止NCT05569005該当なし

The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System (THS) as compared to those who continue to smoke cigarettes.

対象疾患:
COPDSmokingTobacco Use

VAXZEVRIAの長期安全性に関する日本における市販後調査(PMS)

完了NCT05135455

This survey will be conducted for the subjects who participate in the priority survey (cohort survey) conducted by the Scientific Research Group of the Ministry of Health, Labour and Welfare at the initial stage of administration of the COVID-19 vaccination. The present study aims to collect information on serious adverse events or COVID-19 infection observed from 28 days after the last vaccination of VAXZEVRIA up to 12 months after the last vaccination and to evaluate the long-term safety of this vaccine.

対象疾患:
Prevention of Infectious Disease Caused by SARS-CoV-2

Scemblix錠の特別薬物使用結果監視

完了NCT05421091

Uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

対象疾患:
Chronic Myeloid Leukemia