治験一覧
8,963 件中 461〜480 件を表示
膵臓がんの成人患者におけるポンセグロマブという薬剤の効果に関する研究。膵臓がんは転移し、著しい体重減少と倦怠感を引き起こした。
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
KRAS G12C変異を有する未治療の非扁平上皮非小細胞肺癌患者を対象とした、アダグラシブ＋ペムブロリズマブ＋化学療法とプラセボ＋ペムブロリズマブ＋化学療法の併用を比較する試験（KRYSTAL-4）
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
多系統萎縮症患者を対象としたYA-101の第2相試験
This is a Phase 2, double-blind, placebo-controlled, multi-center, Phase II, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ya-101 in subjects with multiple system atrophy.
膵臓がん検出コンソーシアム
This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.
pCRを達成できなかったTNBCにおけるサシツズマブ・ティルモテカン（MK-2870）＋ペムブロリズマブとTPCの比較（MK-2870-012）
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
小細胞肺癌（SCLC）患者におけるタルラタマブ投与レジメンの第2相、非盲検、無作為化、多施設共同試験
The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).
AKT1 E17K変異固形腫瘍の成人における研究薬ALTA2618について知るための研究
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
糖原病Ia型（GSDIa）疾患モニタリングプログラム
この観察研究の主な目的は、DTX401 投与後少なくとも 10 年間にわたる DTX401 の長期的な安全性と有効性を評価することです。
非アルコール性脂肪性肝疾患に対するペマフィブラートの有効性と安全性
This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.
肥満または過体重の日本人被験者を対象としたLY3841136の研究
The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.
膀胱がん患者におけるTAR-210と単剤膀胱内癌治療の比較試験
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
成人被験者における中等度から重度の額のしわの変化に対するオナボツリヌス毒素A筋肉内注射の有害事象と有効性を評価する研究
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of onabotulinumtoxinA in Japanese adults with moderate to severe FHL. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan. In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months. 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 the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
スペソリマブが壊疽性膿皮症と呼ばれる皮膚疾患の患者に効果があるかどうかを検証する研究
この研究の目的は、スペソリマブという薬剤が壊疽性膿皮症（PG）の患者に有効かどうかを調べることです。主な目的は、スペソリマブがPGの潰瘍を閉鎖させるかどうかを検証することです。この研究は、5cm²から80cm²の大きさの潰瘍を少なくとも1つ有する潰瘍性PGの成人患者を対象としています。 この研究は2つのパートに分かれています。パート1では、参加者はランダムに、つまり偶然にグループ分けされます。1つのグループにはスペソリマブが投与され、もう1つのグループにはプラセボが投与されます。プラセボの点滴はスペソリマブの点滴と似ていますが、薬剤は含まれていません。すべての参加者は、3分の2の確率でスペソリマブを投与されます。最初の8週間は、参加者は経口でコルチコステロイドも服用します。 パート2では、参加者は再びグループ分けされます。潰瘍が開いていない参加者は、スペソリマブまたはプラセボを投与される可能性が等しくあります。皮膚潰瘍のある参加者にはスペソリマブが投与されます。 どちらの試験でも、参加者は4週間ごとにスペソリマブまたはプラセボを静脈内注射で投与されます。 参加者は約1年半にわたって試験に参加します。この期間中、参加者は試験実施施設を20回訪れます。試験の来院時に、医師は参加者の皮膚を検査し、PGの兆候がないか確認します。また、医師は定期的に参加者の健康状態をチェックし、望ましくない副作用がないか記録します。各群の結果を比較することで、治療の有効性を確認します。
早期アルツハイマー病患者におけるE2814とレカネマブの併用療法に関する研究
The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).
LIVERAGE™：中等度または進行した肝線維症を伴うNASH/MASHと呼ばれる肝疾患患者に対するスルボデュタイドの効果を検証する試験
This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
再発性または難治性でレナリドミド投与歴のある多発性骨髄腫の成人患者を対象に、BMS-986393と標準治療レジメンの有効性と安全性を比較する試験（QUINTESSENTIAL-2）
The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
12歳以上の中等度から重度のアトピー性皮膚炎患者（背景：外用コルチコステロイド）における皮下アムリテリマブの有効性と安全性を評価する試験
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
再発性または難治性多発性骨髄腫の成人患者を対象とした、皮下注射によるABBV-383の有害事象および臨床活性を評価する試験
Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration. 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 questionnaires.
MTAP遺伝子欠損進行NSCLC患者を対象としたAMG 193の第2相試験（MTAPESTRY 201）
The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).
HAEタイプIまたはIIの小児患者（2～11歳）を対象としたセベトラルスタット（KVD900）のオープンラベル安全性、PK、および有効性試験
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.