治験一覧
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抗腫瘍壊死因子（TNF）療法が無効で生物学的療法未経験の中等度から重度の化膿性汗腺炎の成人患者における皮下ルチキズマブ（ABT-981）の疾患活動性と安全性を評価する試験
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. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 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 medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.
BI 685509単独またはエンパグリフロジンとの併用が、門脈（肝臓につながる主要血管）の血圧が高いウイルス性肝炎または非アルコール性脂肪肝炎（NASH）に起因する肝硬変患者に効果があるかどうかを検証する研究
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin helps people with this condition. Participants take Avenciguat (BI 685509) as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to Avenciguat (BI 685509). Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.
薬物治療抵抗性の中等度から重度の運動合併症を伴う進行性特発性パーキンソン病の治療における片側淡蒼球切除術用エクサブレート4000タイプ1.0およびタイプ1.1の承認後レジストリ
このレジストリは、承認後における前向き、多施設、国際、単群、観察レジストリであり、3、6、12ヶ月後、および5年間毎年追跡調査を行います。本レジストリは、60名の被験者を登録し、世界約10施設で実施される予定です。
進行癌患者を対象に、BI 770371単独またはエザベンリマブとの併用における異なる用量の忍容性を検証する研究
This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study. The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab. BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time. Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks. It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.
中等度から重度の活動性潰瘍性大腸炎患者を対象としたグセルクマブ療法の研究
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
非弁膜性心房細動（不整脈の一種）患者における出血リスクが高い場合の、アピキサバンとワルファリンの安全性および有効性の比較
* The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database. * Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots. * An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients. * Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial. * Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s). * This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding
卵巣がん患者における完全腫瘍縮小後のニラパリブとベバシズマブの併用療法
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.
抗レトロウイルス療法（ART）によりウイルス学的抑制が得られたヒト免疫不全ウイルス1型（HIV-1）患者におけるドラビリン/イスラトラビル（DOR/ISL）への切り替え（MK-8591A-051）
The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.
中等度から重度の化膿性汗腺炎患者におけるポボルシチニブ（INCB054707）の有効性と安全性を評価する研究
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.
同種造血幹細胞移植を受けるAML患者における補助療法および維持療法としてのモクラビモド
This is a multi-center, randomized, double-blinded, placebo controlled trial.
中等症から重症の尋常性乾癬を有する日本人小児患者におけるアプレミラストの有効性と安全性を評価する研究
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
血行再建術を受けていない慢性冠症候群患者におけるアスピリンの有効性と安全性
The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.
ミエリンオリゴデンドロサイト糖タンパク質抗体関連疾患患者におけるサトラリズマブの有効性、安全性、薬物動態および薬力学を評価する試験
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
慢性腎臓病または心不全患者における高カリウム血症の長期管理に関する観察的前向きコホート研究
This prospective observational research will be conducted to assess the burden of hyperkalemia including treatment and disease burden of patients in a long-term continuous care from various aspects including adherence to the medication for hyperkalemia and HR-QoLs.
ホルモン受容体陽性／ヒト上皮成長因子受容体2陰性（HR+/HER2-）進行乳がん患者における内分泌療法の実際の治療パターン：日本の医療費請求データ分析
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database. The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.
ER+/HER2-の局所進行性または転移性乳がん患者におけるベプデゲストラント（ARV-471、PF-07850327）に関する知見を得るための研究
The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in Japanese participants with ER+/HER2- locally advanced or metastatic breast cancer (mBC).
健康な日本人男性を対象に、BI 1291583の異なる用量に対する忍容性を検証する研究
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
CagriSemaが2型糖尿病と過剰体重の患者の減量にどれほど効果的かを調べる研究
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
再発性および/または難治性B細胞悪性腫瘍におけるPIT565の研究
This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
EPIC-Peds：入院はしていないが重症化リスクのある18歳未満のCOVID-19患者を対象に、PF-07321332（ニルマトレルビル）/リトナビルという治験薬の効果を調べる研究
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.