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KMT2Ar、NPM1m、またはHOX過剰発現に関連する他の遺伝子型を有する進行性血液悪性腫瘍患者におけるAZD3632単独療法または抗癌剤との併用療法の研究

募集中NCT07155226第1/第2相

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

対象疾患:
Acute Lymphoblastic LeukaemiaAcute Myeloid LeukaemiaHigher-risk Myelodysplastic Syndromes

エルゴチオネイン含有サプリメントの継続摂取による皮膚状態への影響

完了NCT06886061該当なし

This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.

対象疾患:
Skin

エテンタミグ(ABBV-383)を静脈内(IV)注入単独または経口、IV、皮下ダラツムマブ、レナリドミド、デキサメタゾン、カルフィルゾミブとの併用で投与された多発性骨髄腫の成人参加者における疾患活動性および有害事象(AE)の変化を評価する研究

募集中NCT06892522第1/第2相

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, efficacy, and pharmacokinetics of Etentamig in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

対象疾患:
多発性骨髄腫

中等度から重度の活動性潰瘍性大腸炎患者におけるドゥバキトゥグの有効性と安全性を調査するための導入試験

募集中NCT07184996第3相

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include: The study duration may be up to 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

対象疾患:
Ulcerative Colitis

急性精神病を呈する統合失調症の日本人成人患者におけるKarXTの有効性と安全性を評価する研究

募集中NCT06882785第3相

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

対象疾患:
統合失調症

高血圧および肥満または過体重の参加者を対象としたオルフォルグリプロン(LY3502970)のマスタープロトコル試験(ATTAIN-Hypertension)GZL1

募集中NCT06948435第3相

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

対象疾患:
HypertensionOverweight or Obesity

リヒター変換患者を対象としたONO-4538試験

募集中NCT06936943第2相

Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation

対象疾患:
リヒターの変容

中等度から重度の活動性潰瘍性大腸炎(UC)患者におけるRO7837195の有効性、安全性、および薬物動態(PK)を評価する研究

募集中NCT06979336第2相

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

対象疾患:
潰瘍性大腸炎

関節リウマチ患者における皮下MTX療法中のMTX-PG濃度の変化(COSMOS研究)

募集中NCT06913907第4相

Methotrexate is known to exist intracellularly as methotrexate polyglutamate, which is formed by the addition of glutamic acid after absorption into the body. The objective of this study is to measure the concentration of methotrexate polyglutamate in red blood cells and peripheral blood mononuclear cells after initiating methotrexate treatment in patients with rheumatoid arthritis who have no prior history of using methotrexate (either subcutaneous or oral formulations). Additionally, we aim to examine changes in methotrexate polyglutamate concentrations when switching from oral methotrexate to subcutaneous Metoject, as well as to investigate the relationship between methotrexate polyglutamate concentration and the efficacy and safety of the treatment. Another objective of this study is to evaluate whether switching to subcutaneous Metoject allows for an increased maximum tolerable dosage while maintaining safety.

対象疾患:
Rheumatoid Arthritis (RA)

転移性前立腺癌の日本人患者を対象としたJSB462(ルクスデガルタミド)の第I相試験

募集中NCT07174063第1相

This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.

対象疾患:
Metastatic Prostate Cancer (mCRPC)

円形脱毛症の成人および青年患者を対象としたウパダシチニブ錠の安全性および有効性を評価する試験

募集中NCT07023302第3相

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants in Japan with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In Period B, participants originally randomized to a upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will be re-randomized in 1 of 2 groups receiving upadacitinib. Participants who complete Period B can join Period C and will receive 1 of 2 doses of upadacitinib for up to 52 weeks based on their SALT score. Around 123 adolescent and adult participants with severe AA will be enrolled in the study at approximately 20 sites in Japan. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 104 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after their last study drug dose. 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.

対象疾患:
Alopecia Areata

TheraSphere Japan 市販前調査

募集中NCT07377487該当なし

To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.

対象疾患:
肝腫瘍

リスクのある小児および成人におけるステージ3の1型糖尿病の発症遅延を目的としたバリシチニブ(LY3009104)の研究

募集中NCT07222137第3相

The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.

対象疾患:
1型糖尿病

転移性前立腺癌患者におけるイフィナタマブ デルクステカン(I-DXd)の臨床試験(MK-2400-001)

募集中NCT06925737第3相

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy,

対象疾患:
前立腺がん前立腺腫瘍

転移性去勢抵抗性前立腺癌患者におけるパスリタミグとドセタキセルの併用とドセタキセル単独の併用を比較する試験

募集中NCT07225946第3相

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

対象疾患:
去勢抵抗性前立腺腫瘍

左室肥大を伴う心不全患者における心臓の構造と機能に対するCDR132Lの異なる用量とプラセボの比較研究

募集中NCT06979362第2相

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

対象疾患:
心不全

肥満または2型糖尿病を患っていない過体重の参加者を対象としたエロラリンタイド(LY3841136)の研究

募集前NCT07321886第3相

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase. Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

対象疾患:
ObesityOverweight

中等度から重度のアルコール使用障害患者を対象としたブレニパチドの研究

募集中NCT07219966第3相

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.

対象疾患:
Alcohol Use Disorder

重症喘息の成人患者を対象としたVerekitug(UPB-101)の長期安全性および有効性試験(VALOUR)

募集中NCT06966479第2相

The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).

対象疾患:
Severe Asthma

薬剤耐性肺結核の治療におけるクアボデピスタット含有レジメンの研究

募集中NCT07209761第3相

This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.

対象疾患:
Pulmonary Tuberculosis