[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SynAct Pharma Aps\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643581","phase-2-a-clinical-trial-evaluating-the-safety-and-efficacy-of-ap1189-versus-placebo-as-an-add-on-to-standard-of-care-in-participants-with-respiratory-insufficiency-expected-to-be-caused-by-infection-with-respiratory-viruses-100643581",false,"NCT07633288","A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses","A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus","RESPIRE","Inclusion Criteria:\n\n* Written informed consent has been obtained prior to initiating any study-specific procedures\n* Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative PCR, or quantitative PCR (Q-PCR).\n* Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or supplementary oxygen supply via nasal catheter or facial mask (WHO Clinical Progression Scale score 5 or 6). Or in participants with hypercapnic respiratory failure (usually due to COPD) the SpO2 threshold is SpO2 ≤ 85 %.\n* Duration of disease from first symptom\\\u003C 15 days before enrolment\n* Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized\n* Females of childbearing potential with a negative pregnancy test at screening and baseline\n* As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups.\n* Screened within 24 hours of hospital admission to the hospital, or within 24 hours of receiving a patient, if the patient is transferred from another hospital or another hospital department due to respiratory distress\n\nExclusion Criteria:\n\n* In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment\n* Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical ventilation, ECMO, cardiovascular organ support (balloon pump or inotropes\u002Fvasopressors), or renal failure (Cockcroft-Gault estimated creatinine clearance \\\u003C15 ml\u002Fmin, haemofiltration or dialysis). Note: participants qualifying under inclusion criterion 8b (pre-existing renal insufficiency or dialysis) are excluded only if they meet any of the other criteria (invasive mechanical ventilation, ECMO, or cardiovascular organ support). Participants who are physically located in an ICU or HDU but do not meet the above physiological criteria are not excluded on that basis alone.\n* Participating in other drug clinical trials\n* Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures\n* Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases. Administration of steroids or other immunosuppressive medicines implemented as standard-of-care for the treatment of the respiratory viral infection is acceptable. Asthma\u002FCOPD participants are allowed to use their habitual inhalation spray containing adrenocortical hormone.\n* Pregnant women or nursing (breastfeeding) mothers","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.",[27],"Respiratory Viral Infection",[29,30,31],"Influenza","Respiratory Syncytial virus,","Corona virus","RECRUITING","2026-06-08",{"date":35,"type":36},"2026-06-11","ACTUAL",{"date":38,"type":36},"2026-05-01",{"date":40,"type":21},"2027-08-01",{"name":42,"class":43},"SynAct Pharma Aps","INDUSTRY",11,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100397568","phase-2-a-study-of-the-safety-tolerability-pharmacokinetics-and-efficacy-of-treatment-with-ap1189-in-patients-with-imn-and-severe-proteinuria-100397568","NCT04456816","A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria","An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria","Inclusion Criteria:\n\n* Written informed consent has been obtained prior to initiating any study-specific procedures\n* Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion\n* Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion\n* Severe proteinuria defined by a U-protein\u002Fcreatinine ratio \\>3.0 g\u002Fg and\u002For U-albumin\u002Fcreatinine ratio \\>2.0 g\u002Fg and a P-albumin below the lower normal limit\n* eGFR \\> 30 ml\u002Fmin\u002F1.73m2\n* Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and\u002For angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect\n\nOnly Denmark and Norway:\n\n* Females of child-bearing potential using reliable means of contraception or are post-menopausal\n* Females of childbearing potential with negative pregnancy test at screening and baseline\n\nOnly Sweden:\n\n* Post-menopausal women or women who are surgically sterilized.\n\nExclusion Criteria:\n\n* Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry\n* Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria\n* Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization\n* Blood pressure with systolic pressure above 160 mmHg and\u002For diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered \"uncontrolled\"\n* Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit\n* Treated with rituximab within 12 months of screening\n* Evidence of active malignant disease\n* Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids\n* Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease\n* Pregnant women or nursing mothers\n* History of alcohol, drug, or chemical abuse within the 6 months prior to screening\n* Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures\n\nOnly Sweden:\n\n* Females of child-bearing potential.","85 Years",{"count":54,"type":21},23,[24],"This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.",[58,59],"Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy","Severe Proteinuria Due to Idiopathic Membranous Nephropathy","2026-03-04",{"date":62,"type":36},"2026-03-06",{"date":64,"type":36},"2020-08-31",{"date":66,"type":21},"2026-06-30",{"name":42,"class":43},1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},"100567658","phase-2-a-dose-response-study-to-evaluate-the-efficacy-and-safety-of-oral-ap1189-administered-in-disease-modifying-anti-rheumatic-drug-dmard-nave-participants-participants-with-early-rheumatoid-arthritis-100567658","NCT06671054","A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis","A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.","Inclusion Criteria:\n\n* Signed and dated informed consent obtained before undergoing any trial-specific procedure.\n* Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria.\n* Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.\n* Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)\n* Participants with at least 6\u002F68 tender and 6\u002F66 swollen joints at Screening Visit and Baseline.\n* Participants with \"high\" disease activity as documented by a Disease Activity Score 28 (DAS28) (C-Reactive Protein - CRP) index score \\> 5.1 at screening, and Clinical disease activity index (CDAI) \\>22 at Screening Visit and Baseline.\n* Participants with serum high sensitive C-Reactive Protein (hsCRP) ≥3 mg\u002FL at the time of screening.\n* Participants positive for serum rheumatoid factor (RF), AND\u002FOR anti-cyclic citrullinated peptide antibodies (anti-CCP). If seronegative RA, hsCRP ≥6 mg\u002FL at the time of screening.\n* Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.\n* Females of childbearing potential must have a negative pregnancy test at screening and again at baseline.\n* Sexually active female participants of childbearing potential and male participants are excluded if not practicing two different methods of birth control with their partner during the study and for 90 days after the last dose of study drug or who will not remain abstinent during the study and for 90 days after the last dose.\n\nExclusion Criteria:\n\n* Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.\n* Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.\n* Current inflammatory joint disease other than RA.\n* Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and\u002For severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.\n* Gastrointestinal diseases known to interfere with the absorption or excretion of medications.\n* Severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.\n* Malignancy active during the 12 months preceding the Screening Visit.\n* Acute hepatitis, chronic hepatitis, or detection of any unexplained elevation of serum ALT or AST greater than 1.5-fold ULN, at least twice in the 6 months before the Screening Visit) or HIV infection.\n* History of alcohol or drug abuse during the 12 months preceding the Screening Visit.\n* Vaccination with live vaccines during the 6 weeks preceding the Screening Visit.\n* Haemoglobin \\\u003C9 g\u002FdL or Haematocrit \\\u003C30% at the Screening Visit\n* White blood cell (WBC) count \\\u003C3.0 x 109\u002FL at the Screening Visit.\n* Absolute neutrophil count \\\u003C1.2 x 109\u002FL at the Screening Visit.\n* Platelet count \\\u003C100 x 109\u002FL at the Screening Visit.\n* Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.\n* Estimated creatinine clearance less than 45 mL\u002Fmin\u002F1.73 m2 (MDRD) at the Screening Visit.\n* 12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.\n* Positive QuantiFERON-in-Tube test (QFG-IT).\n* Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.\n* Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.\n* Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.\n* Use of other investigational drugs\u002Ftreatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.\n* Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.",{"count":77,"type":21},240,[24],"The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.",[81],"Rheumatoid Arthritis (RA)","2025-10-03",{"date":84,"type":36},"2025-10-06",{"date":86,"type":36},"2024-10-01",{"date":88,"type":21},"2025-12",{"name":42,"class":43},""]