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健康な日本人被験者および2型糖尿病患者を対象としたAZD5004の反復漸増投与試験

完了NCT06703658第1相

This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.

対象疾患:
Healthy ParticipantsType 2 Diabetes

転移性扁平上皮非小細胞肺癌(NSCLC)におけるペムブロリズマブ併用または維持療法なしのサシツズマブ チルモテカン(Sac-TMT; MK-2870)[MK-2870-023]

募集中NCT06422143第3相

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

対象疾患:
非小細胞肺癌非小細胞肺がん

肥満または過体重で、少なくとも1つの体重関連合併症を有する参加者を対象とした研究

完了NCT06595238第2相

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

対象疾患:
Obesity or Overweight

試験食品の長期摂取の安全性を評価するための検証研究

実施中(募集終了)NCT06715475該当なし

This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.

対象疾患:
Healthy Japanese

選択された進行固形腫瘍患者を対象としたLY4170156の研究

募集中NCT06400472第1相

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

対象疾患:
Carcinoma, Non-Small-Cell LungColorectal NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsPancreatic Neoplasm2

ADPKD患者におけるタミバロテンの研究

実施中(募集終了)NCT06289998第2相

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

対象疾患:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

ブリストル・マイヤーズ スクイブ社製の遺伝子改変細胞療法を受け、二次性悪性腫瘍と診断された患者からの腫瘍サンプルの遺伝子導入アッセイ検査サービス

募集中NCT06357754

The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.

対象疾患:
Chronic Lymphocytic LeukaemiaMultiple MyelomaNon-Hodgkin Lymphoma

中等度から重度の活動性潰瘍性大腸炎の小児患者を対象としたグセルクマブの試験

実施中(募集終了)NCT06260163第3相

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

対象疾患:
大腸炎、潰瘍性

代償性肝硬変を伴う原発性胆汁性胆管炎患者および肝硬変を伴わない患者における K-808 (ペマフィブラート) の薬物動態および安全性を評価する研究。

完了NCT06525311第1相

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.

対象疾患:
Compensated CirrhosisPrimary Biliary Cholangitis

TAK-279の安全性と、中等度から重度の活動性クローン病患者の腸の炎症を軽減できるかどうかに関する研究

募集中NCT06233461第2相

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.

対象疾患:
Crohn's Disease

EGFRm陽性局所進行性または転移性非小細胞肺癌に対するオシメルチニブ単独またはダトポタマブ デルクステカン併用による第一選択薬の第III相オープンラベル試験

募集中NCT06350097第3相

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 9 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

対象疾患:
Non-small Cell Lung Cancer

同時左心房耳閉鎖術とパルスフィールドアブレーション-アジア

募集中NCT06686485

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

対象疾患:
Atrial FibrillationConcomitant ProceduresLAACPFA

早期アルツハイマー病患者における抗MTBRタウモノクローナル抗体(BMS-986446)の有効性、安全性、忍容性を評価する研究

実施中(募集終了)NCT06268886第2相

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

対象疾患:
Alzheimer Disease, Early Onset

全身性重症筋無力症の成人患者におけるレミブルチニブとプラセボの有効性、安全性および忍容性を検討する試験

募集中NCT06744920第3相

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.

対象疾患:
全身性重症筋無力症

増悪リスクのあるコントロール不良喘息の成人におけるAZD8630の多用量投与の有効性と安全性を評価する用量範囲探索試験

実施中(募集終了)NCT06529419第2相

A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).

対象疾患:
Asthma

中等度から重度の化膿性汗腺炎の成人および青年患者におけるルチキズマブの疾患活動性と安全性を評価する研究

募集中NCT06468228第3相

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

対象疾患:
化膿性汗腺炎

非嚢胞性線維症性気管支拡張症患者におけるイテペキマブ(抗IL-33 mAb)の有効性、安全性および忍容性を評価する概念実証研究

完了NCT06280391第2相

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.

対象疾患:
気管支拡張症

日本人患者における再発性低悪性度漿液性卵巣癌に対するアブトメチニブ+デファクチニブの試験

実施中(募集終了)NCT06682572第2相

This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

対象疾患:
Low Grade Serous Ovarian CancerOvarian Cancer

進行性消化器がん、胆道がん、または膵臓がんのホモ接合性メチルチオアデノシンホスホリラーゼ(MTAP)欠失患者を対象としたAMG 193と他の治療法の併用を評価する試験(MTAPESTRY 103)

募集中NCT06360354第1相

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.

対象疾患:
進行した消化器がん、胆道がん、膵臓がん

PD-L1(プログラム細胞死リガンド1)発現率の高い非小細胞肺がん(NSCLC)患者における、ベルレストタグとドスタルリマブの併用療法とプラセボとペムブロリズマブの併用療法を比較した試験

実施中(募集終了)NCT06472076第3相

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

対象疾患:
Lung Cancer, Non-Small Cell