治験一覧
8,963 件中 921〜940 件を表示
中等症から重症のアトピー性皮膚炎を有する2歳から12歳未満の小児におけるウパダシチニブと外用コルチコステロイドの併用療法の安全性と有効性
Pediatric atopic dermatitis (AD), also known as childhood eczema, is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to assess the change in disease activity (Efficacy) and to assess the safety of upadacitinib in combination with topical corticosteroids (TCS) in pediatric participants 2 to 11 years of age in Japan with moderate to severe AD who are candidates for systemic therapy. Upadacitinib is approved for the treatment of moderate to severe AD in adults and adolescents 12 years of age and older in many countries, including Japan. This study comprises a 35-day screening period; a 12-week, randomized, double-blind treatment period where there will be a 1 in 2 chance that a participant is assigned placebo. This will be followed by an open-label upadacitinib treatment period up to Week 52. Around 98 participants will be enrolled in the study at approximately 35 sites in Japan. Participants will receive upadacitinib oral tablets, or matching placebo, once daily (or an adult equivalent oral solution dose twice a day) for up to 52 weeks. 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 clinical assessments, blood tests, checking for side effects and completing questionnaires.
健康な日本人におけるオラムキセプトの安全性、忍容性、免疫原性および薬物動態の調査
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.
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。
多発性筋痛症（PMR）におけるセクキヌマブのオープンラベル長期安全性試験
The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.
進行固形腫瘍患者を対象としたGSK5764227の試験（EMBOLD PanTumor-101）
The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of GSK5764227. The study will also see how the levels of GSK5764227 will change over time at different dose amounts when administered alone and in combination with other medicines like carboplatin, cisplatin, atezolizumab, pembrolizumab, durvalumab, bevacizumab, cetuximab.
原発性進行または再発子宮内膜癌の日本人患者を対象とした、ドスタルリマブとカルボプラチン・パクリタキセルの併用療法に関する研究
The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer
健康なボランティアを対象としたTRN501の第I相試験
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.
18歳以上の男女を対象に、デュピルマブ注射とプラセボを比較した慢性単純性苔癬の掻痒改善効果を調査する研究（STYLE 1）
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
転移性非扁平上皮非小細胞肺癌患者におけるSB27とキイトルーダの有効性、安全性、薬物動態および免疫原性を比較する試験
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is: • How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks. Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.
成人における反復性または慢性片頭痛の予防におけるIPN10200の安全性と有効性を評価する研究
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: * The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, * The right amount (dose) of IPN10200 to inject at each point, * The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.
再発性・難治性多発性骨髄腫患者におけるアニトカブタゲンオートロイセルと標準治療の比較試験
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.
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。
中等度から重度のクローン病患者におけるトゥリソキバート（MK-7240）の有効性と安全性を評価する試験（MK-7240-008）
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).
進行HER2発現胆道癌におけるT-DXdおよびリルベゴストミグとSoCを比較する第3相試験
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
原発性血小板血症に対するボメデムスタットとヒドロキシウレアの比較（MK-3543-007）
The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.
原発性シェーグレン症候群患者におけるエフガルチギモドの有効性と安全性に関する研究
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
中等度から重度の活動性全身性エリテマトーデス患者を対象としたダピロリズマブペゴルの有効性と安全性を評価する試験
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
実際の使用状況下でエルラナタマブを投与された再発性および難治性多発性骨髄腫患者の安全性と有効性を調査するための非介入研究。
To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.
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-4578とニボル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調査する研究
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
二次治療を受けた末梢性T細胞リンパ腫の日本人患者を対象とした観察研究
The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan