[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Teva Branded Pharmaceutical Products R&D LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,64,87,108],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100644828",false,"NCT07674940","A Trial to Assess TEV-56286 at Different Doses in Healthy Participants","A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses","Inclusion Criteria:\n\n* Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg\u002Fm2 inclusive.\n* Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).\n* Female participants are eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n* A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone \\[FSH\\] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).\n* A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), used consistently and correctly. The acceptable contraceptive regimen in this trial is: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.\n* Male participants are eligible to participate if they are azoospermic (vasectomized or due to a medical cause) or, alternatively, agree to the following during the trial period, from admission (day -1) and for at least 28 days after last dose of IMP.\n\nRefrain from donating sperm, in addition to following:\n\n* EITHER be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n* OR must agree to use contraception\u002Fbarrier as detailed below:\n\n  * Agree to use a male condom with female partner using an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year when having sexual intercourse with a WOCBP who is not currently pregnant.\n  * Agree to use a male condom when having sexual intercourse with a pregnant partner.\n\nNOTE-Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence\u002Fhistory of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.\n* Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.\n* The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).\n* Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.\n* Participant has a personal or family history of arrhythmia, long QT syndrome, or sudden unexplained death in a first-degree relative before the age of 40; or personal history of syncope, myocardial infarction, cerebrovascular accident, or previous treatment for high blood pressure (BP).\n* Participant has an alkaline phosphatase (ALP), alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\>1.5 × upper limit of normal (ULN).\n* Participant has a history of alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association 2013) or are unwilling to comply with the restricted food or beverages during the trial.\n* Participant is a current smoker, has smoked in the last 6 months, is planning to start smoking during the trial, uses tobacco, or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, e-cigarettes, vaping devices, inhalers), or has a positive urine cotinine test.\n\nNOTE-Additional criteria apply, please contact the investigator for more information",true,"ALL","18 Years","60 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.\n\nThe main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.\n\nA secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.\n\nThe estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+\u002F-1 days post discharge from the clinical unit.\n\nThe estimated duration for participants in Part 2 with Multiple Dose is approximately 64 days; including 45 days of screening, a 10-day in-clinic period, and follow-up 8+\u002F-1 days post discharge from the clinical unit.",[27],"Healthy Volunteers","NOT_YET_RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":21},"2026-06-29",{"date":36,"type":21},"2027-01-22",{"name":38,"class":39},"Teva Branded Pharmaceutical Products R&D LLC","INDUSTRY",{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100567164","NCT06664619","A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate\u002FAlbuterol Sulfate Combination in Participants 12 Years and Older With Asthma","A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate\u002FAlbuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma","Inclusion Criteria:\n\n* The participant has a diagnosis of asthma of at least 6 months duration.\n* Participants currently receive a beta-agonist (eg, salbutamol \\[albuterol\\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication.\n* If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the trial), or is of non-childbearing potential.\n\nNOTE- Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode.\n* The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering screening.\n* The participant is a current smoker and\u002For has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping\u002F e-cigarettes, hookah\u002Fwaterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded.\n* The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome.\n\nNOTE- Additional criteria apply, please contact the investigator for more information","12 Years",{"count":48,"type":21},724,[50],"PHASE3","The primary objective of the trial is to evaluate the efficacy of fluticasone propionate\u002Falbuterol sulfate multidose dry powder inhaler with electronic module (Fp\u002FABS eMDPI).\n\nSecondary objectives are:\n\n* To evaluate the efficacy of Fp\u002FABS eMDPI administered four times daily\n* To evaluate the safety and tolerability of Fp\u002FABS eMDPI administered four times daily over four weeks\n* To investigate the pharmacokinetics of Fp\u002FABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose\n\nThe planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.",[53],"Asthma","RECRUITING","2026-06-24",{"date":57,"type":32},"2026-06-25",{"date":59,"type":32},"2024-12-12",{"date":61,"type":21},"2026-09-19",{"name":38,"class":39},183,{"id":65,"slug":4,"hasResults":10,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":10,"sex":16,"minAge":70,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100608154","NCT07197866","An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy","An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy","Inclusion Criteria:\n\n* Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements\n* Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit\n* Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP\n* Males who are potentially fertile\u002Freproductively competent (not surgically \\[eg, vasectomy\\] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product\n\nNOTE - Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial\n* Is of a vulnerable population (eg, people kept in detention or jail)\n* Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial\n\nNote - Additional criteria apply, please contact the investigator for more information","30 Years",{"count":72,"type":21},200,[74],"PHASE2","The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).\n\nA secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.\n\nThe planned total duration of the trial is approximately 100 weeks.",[77],"Multiple System Atrophy","2026-06-16",{"date":80,"type":32},"2026-06-17",{"date":82,"type":32},"2025-09-30",{"date":84,"type":21},"2029-05-17",{"name":38,"class":39},27,{"id":88,"slug":4,"hasResults":10,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":10,"sex":16,"minAge":70,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":20},"100559753","NCT06568237","A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy","A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)","TOPAS-MSA","Inclusion Criteria:\n\n* is considered to be \"clinically possible\" or \"clinically probable\" MSA as determined by the Gilman criteria\n* is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination\n* Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits\n* Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods\n* Males who are potentially fertile\u002Freproductively competent (not surgically \\[eg, vasectomy\\] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods\n\n  * Additional criteria apply; please contact the investigator for more information\n\nExclusion Criteria:\n\n* has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA\n* has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening\n* has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening\n* is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study\n* has a known hypersensitivity to any components of the IMP\n* is of a vulnerable population (eg, people kept in detention or jail)\n* participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study\n\n  * Additional criteria apply; please contact the investigator for more information","75 Years",{"count":96,"type":21},350,[74],"The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).\n\nA secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286.\n\nAnother secondary objective is to evaluate the safety and tolerability of TEV-56286.\n\nThe planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.",[77],[101],"Multiple System Atrophy (MSA)",{"date":80,"type":32},{"date":104,"type":32},"2024-10-02",{"date":106,"type":21},"2027-09-15",{"name":38,"class":39},{"id":109,"slug":4,"hasResults":10,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100553012","NCT06480552","An Open-label Dose Escalation\u002FExpansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, as a Monotherapy and in Combination With Pembrolizumab in Participants With Selected Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy\n* Have a life expectancy≥12 weeks at the time of the screening\n* Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication\n* Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication\n\nNOTE- Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline\n* Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening\n* Has a diagnosis of immunodeficiency\n* Has active known autoimmune disease.\n* Has a history of or known active brain metastases and\u002For carcinomatous meningitis and\u002For leptomeningeal metastasis\n* Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline\n* Has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening\n* Has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis\n* Has a seizure disorder requiring therapy (such as steroids or antiepileptics)\n\nNOTE- Additional criteria apply, please contact the investigator for more information",{"count":115,"type":21},240,[24],"The primary objectives of this trial are to:\n\n* Characterize the safety and tolerability of TEV-56278\n* Determine the Recommended Phase 2 Dose (RP2D)\n* Evaluate antitumor activity of TEV-56278 (Part 2 only)\n* Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab\n* Determine a RP2D of TEV-56278 in combination with pembrolizumab\n\nThe secondary objectives of this trial are to:\n\n* Characterize the serum pharmacokinetics of TEV-56278\n* Evaluate the antitumor activity of TEV-56278\n* Determine the safety and tolerability of TEV-56278\n* Evaluate other measures of antitumor activity of TEV-56278\n* Evaluate anti-tumor activity\n\nParticipants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.\n\nParticipants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).",[119],"Advanced Solid Tumors","2026-06-02",{"date":122,"type":32},"2026-06-04",{"date":124,"type":32},"2024-07-22",{"date":126,"type":21},"2031-02-25",{"name":38,"class":39},12,""]