[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rise Therapeutics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":169},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,68,92,117,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100513140","phase-1-r-2487-in-patients-with-rheumatoid-arthritis-100513140",false,"NCT05961592","R-2487 in Patients With Rheumatoid Arthritis","A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis","R-2487-RA01","Inclusion Criteria:\n\n* Ages 18-75 years (Inclusive).\n* Able to provide written informed consent.\n* Men or women (not nursing or pregnant) who have active RA, defined as symptoms of RA prior to screening and have satisfied the ACR\u002FEULAR 2010 criteria for the classification of RA prior to signing the informed consent.\n* Subjects must have a CDAI \\> 10.0 at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal) at screening and at Day 1, based on the DAS28 joint count.\n* Subjects may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.\n* Subjects may have received targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA if they have been washed out for 1 month prior to screening.\n* Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of ≤10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or IA administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy.\n* All male and female subjects who are biologically capable of having children must agree to use a medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of study drug. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the study.\n* Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio).\n\nExclusion Criteria:\n\n* Pregnancy (females, unless surgically sterile or at least two years post- menopausal must have a negative serum pregnancy test within 14 days prior to receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug).\n* Nursing mothers.\n* Subjects with autoimmune disease other than RA \\[e.g., psoriasis, systemic lupus erythematosus (SLE), vasculitis, seronegative spondylarthritis, Inflammatory Bowel Disease, Sjogren's syndrome\\] or currently active fibromyalgia.\n* Subjects should not receive any of the following medications:\n* Rituximab within 12 months prior to Day 1,\n* Abatacept within 3 months prior to Day 1,\n* Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or\n* Mycophenolate mofetil within 2 months prior to Day 1, or\n* Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1\n* Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, baricitinib or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).\n* Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).\n* Subjects at risk for tuberculosis (TB) defined as follows: Current clinical, radiographic or laboratory evidence of active TB. Chest x-rays (posterior, anterior and lateral) obtained within the 3 months prior to obtaining written informed consent will be permitted but the images must be available and reviewed by the investigator. TB testing (IFN-gamma release assay or PPD) performed in the past month prior to Screening will be accepted; however, a copy of the report must be placed in the subject binder.\n* A history of active TB.\n* Subjects with a positive TB screening test indicative of latent TB including subjects currently being treated for latent tuberculosis infection (LTBI) will not be eligible for the study.\n* Subjects with recent acute infection defined as:\n* Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics,\n* Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy,\n* Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.),\n* Subjects with any history of infection of a joint prosthesis or artificial joint,\n* Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis),\n* Subjects with history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster will be excluded,\n* Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening,\n* Subjects with history of primary immunodeficiency.\n* Subjects with history of Human Immunodeficiency Virus (HIV) infection or who tested positive for HIV.\n* Evidence of infection with hepatitis B virus (HBV), hepatitis C virus (C), human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening.\n* Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non- metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n* Current clinical findings of a history of a demyelinating disorder.\n* New York Heart Association (NYHA) Class III or IV heart failure.\n* Subjects who have undergone a major surgical procedure within the 60 days prior to enrollment.\n* Subjects for whom 5 or more joints cannot be assessed for tenderness or swelling (i.e. due to surgery, fusion, amputation, etc.).\n* Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:\n* Hemoglobin level \\\u003C 9.0 g\u002FdL,\n* Absolute white blood cell (WBC) count of \\\u003C3.0×109\u002FL (\\\u003C3000\u002Fmm3), or absolute neutrophil count of \\\u003C1.2×109\u002FL (\\\u003C1200\u002Fmm3), or absolute lymphocyte count of \\\u003C0.8×109\u002FL (\\\u003C800\u002Fmm3),\n* Thrombocytopenia, defined by platelet count \\\u003C100×109\u002FL (\\\u003C100,000\u002Fmm3),\n* Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2, based on the age-appropriate calculation,\n* Proteinuria ≥3+,\n* Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN)\n* Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (\\> F3).\n* Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.","ALL","18 Years","75 Years",{"count":21,"type":22},73,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Rheumatoid Arthritis.\n\nPatients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Rheumatoid Arthritis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.",[28],"Arthritis, Rheumatoid",[28],"RECRUITING","2026-06-10",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2023-10-19",{"date":38,"type":22},"2026-12-31",{"name":40,"class":41},"Rise Therapeutics LLC","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100490502","phase-1-r-3750-in-patients-with-mild-to-moderate-ulcerative-colitis-100490502","NCT05666960","R-3750 in Patients With Mild to Moderate Ulcerative Colitis","A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis","INCLUSION CRITERIA:\n\n* 18-65 years of age\n* Ability to provide written informed consent\n* Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9\n* On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug\n* For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)\n* For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available\n* Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy, breastfeeding women\n* Evidence of severe UC disease (MMDAI score greater than or equal to 10)\n* Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV\n* Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months\n* Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months\n* Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry\n* Use of steroidal drugs to treat UC (e.g., prednisone \\>20 mg\u002Fday)\n* Use of probiotics within the last one (1) week and during the trial.\n* Treatment with systemic broad-spectrum antibiotics in the past 2 months\n* Major active systemic autoimmune disease other than UC\n* History of anaphylaxis or allergies to probiotics\n* History of alcohol or drug abuse within the past 2 years\n* History of stroke, or any cerebrovascular disease requiring medication\u002Ftreatment\n* History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix \\>1 year prior to enrollment\n* Significant laboratory abnormalities, including liver transaminases (AST or ALT) \\> 1.5X the upper limit of normal.\n* Second degree or higher heart block or clinically significant arrythmia\n* Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk\n* Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data","65 Years",{"count":51,"type":22},36,[25],"The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis.\n\nPatients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.",[55,56,57,58],"Ulcerative Colitis Chronic Mild","Ulcerative Colitis Chronic Moderate","Ulcerative Colitis Chronic","Ulcerative Colitis",[60],"Colitis",{"date":33,"type":34},{"date":63,"type":34},"2023-02-27",{"date":65,"type":22},"2026-10",{"name":40,"class":41},5,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100642635","phase-1-r-3750-in-patients-with-late-stage-acute-respiratory-distress-syndrome-ards-100642635","NCT07646028","R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)","A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunomodulatory Effects of R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)","R-3750 ARDS","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* Acute Respiratory Distress Syndrome (ARDS) meeting the contemporary clinical definition including all of the following occurring within a 24-hour interval:\n* Hypoxemia defined as PaO2\u002FFiO2 ≤300 mmHg, or SpO2\u002FFiO2 ≤315 if SpO2 is ≤97%;\n* Bilateral pulmonary infiltrates\u002Fopacities on chest imaging consistent with pulmonary edema or fibroproliferative lung injury and not fully explained by pleural effusions, lobar collapse, or atelectasis;\n* Requirement for positive pressure respiratory support, including invasive mechanical ventilation via endotracheal tube;\n* Respiratory failure not fully explained by left atrial hypertension or cardiogenic pulmonary edema; if measured, pulmonary artery wedge pressure should be ≤18 mmHg.\n* Late-stage, non-resolving ARDS, defined as:\n* At least 7 days and no more than 28 days since ARDS onset at the time of enrollment; and\n* Persistent bilateral infiltrates since ARDS onset; and\n* Continued need for substantial respiratory support since ARDS onset.\n* On the day of enrollment, ongoing respiratory impairment demonstrated by:\n* PaO2\u002FFiO2 ≤300 mmHg, or\n* SpO2\u002FFiO2 ≤315 if SpO2 is ≤97%.\n* Subject is receiving invasive mechanical ventilation, or other protocol-defined intensive respiratory support as approved by the Sponsor\u002FMedical Monitor.\n* The treating team considers the subject an appropriate candidate for enteral administration of study drug, including by nasogastric (NG), orogastric (OG), or other enteral tube, and there is an intention to provide enteral nutrition or medication administration through the gastrointestinal tract.\n* For subjects unable to provide consent, legally authorized representative (LAR) consent is obtainable in accordance with local regulations and Institutional Review Board (IRB)\u002FEthics Committee requirements.\n* The investigator judges that the subject is likely to remain under protocol-compatible management and follow-up for the duration of the treatment and key follow-up period.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* More than 28 days since onset of ARDS at the time of enrollment.\n* ARDS that is clearly resolving rapidly, in the judgment of the investigator, such that enrollment in a 28-day rescue-therapy study is not clinically appropriate.\n* Pregnancy or breastfeeding.\n* Participation in another interventional investigational drug or biologic study within 30 days prior to enrollment, or within 5 half-lives of the investigational product, whichever is longer, unless approved by the Sponsor and Medical Monitor.\n* Extracorporeal support for gas exchange at the time of study entry, including ECMO.\n* Inability to use the gastrointestinal tract for study drug administration, including but not limited to:\n\n  * Continuous gastric suction\u002Fdrainage that would preclude dosing,\n  * Bowel discontinuity preventing enteral delivery,\n  * Open abdomen,\n  * Dependence on total parenteral nutrition with no enteral access,\n  * Other conditions that, in the investigator's judgment, make enteral dosing infeasible.\n* Known or suspected bowel ischemia, gastrointestinal perforation, uncontrolled GI bleeding, or other severe gastrointestinal disorder that would substantially increase risk from enteral dosing.\n* Not committed to full supportive care, with the exception that subjects with a do-not-resuscitate order may be eligible if all other indicated intensive supportive treatments are being provided.\n* AIDS by CDC criteria, including documented AIDS-defining illness or CD4 count \\\u003C200 cells\u002Fmm³, if known.\n* Severe immunosuppression, including any of the following:\n* Cytotoxic chemotherapy within 3 weeks prior to enrollment,\n* High-dose corticosteroid exposure defined as cumulative prednisone ≥300 mg equivalent within 21 days prior to enrollment,\n* Ongoing systemic corticosteroid therapy \\>15 mg\u002Fday prednisone equivalent within 7 days prior to enrollment, unless justified as part of standard ARDS care and approved by the Medical Monitor,\n* Other severe acquired or iatrogenic immunodeficiency considered clinically significant by the investigator.\n* Active uncontrolled infection outside the lung that, in the judgment of the investigator, would confound safety assessment or increase subject risk.\n* Severe chronic respiratory disease likely to confound ARDS assessment or outcomes, including:\n* Advanced COPD requiring chronic home oxygen,\n* Clinically significant pulmonary fibrosis or interstitial lung disease,\n* Other severe chronic lung, chest wall, or neuromuscular disorders causing chronic respiratory failure.\n* Diffuse alveolar hemorrhage due to vasculitis.\n* Malignancy or other irreversible chronic condition for which estimated 6-month mortality is ≥50%, in the investigator's judgment.\n* Morbid obesity or body habitus that would substantially impair protocol assessments or ventilatory interpretation, if deemed clinically significant by the investigator.\n* Any condition that, in the opinion of the investigator or Medical Monitor, would make participation unsafe, interfere with interpretation of study results, or be inconsistent with study objectives.",{"count":77,"type":22},20,[25],"The goal of this clinical trial is to learn if R-3750 is safe in \\[in patients with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) . The main question\\[s\\] it aims to answer are:\n\n1. the favorable safety profile\n2. clinical improvement that includes reduced ventilator dependence and improved lung function.\n\nParticipants will be given oral capsules daily and\u002For enteral nasogastric or orogastric (NG\u002FOG tube) if necessary.",[81],"Acute Respiratory Distress Syndrome",[83,81],"ARDS","NOT_YET_RECRUITING","2026-06-09",{"date":33,"type":34},{"date":88,"type":22},"2026-09-01",{"date":90,"type":22},"2028-12-31",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":116,"locationsCount":4},"100598807","phase-1-a-repeat-ascending-dosing-study-of-the-safety-and-clinical-activity-of-r-3750-in-patients-with-mild-to-moderate-copd-100598807","NCT07076290","A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD","R-3750-01-LU","Inclusion Criteria:\n\n* Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society\u002FEuropean Respiratory Society.\n* Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second\u002F Forced vital capacity (FEV1\u002FFVC) ratio of \\\u003C0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1\\>20% and ≤80% of predicted normal values\n* Baseline mMRC dyspnea score 1 to 3\n* Post-bronchodilator FEV1 \\> 50% predicted (GOLD COPD grade 1-2)\n* Smoking pack years ≥ 10 years\n* Age ≥ 40 years\n* Acceptable standard-of-care COPD maintenance therapy includes long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), or combinations thereof (e.g., dual LABA\u002FLAMA, or triple LABA\u002FLAMA\u002FICS therapy). The patient must have been on a stable dose and regimen for at least 4 weeks prior to screening with no changes anticipated during the study unless medically necessary.\n* A history of ≥ 1 exacerbations in the last 12 months\n* Be able to provide written consent; compliant with study procedures and study visits.\n\nExclusion Criteria:\n\n* Patients whose treatment is considered palliative (life expectancy \\\u003C12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis\n* Current smoker or cessation within 3 months of screening, or current use of vaping device\n* Patients with pneumonia or COPD exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1\n* Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure \\[e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)\\] that will affect the study.\n* Myocardial infarction, unstable angina or stroke within 12 months prior to screening\n* Diagnosis of malignancy within 5 years of study Day 1(except for excised localized carcinoma of skin not including malignant melanoma)\n* Clinically significant ECG changes, which in the opinion of investigator warrants further investigations\n* Evidence of alcohol, drug or solvent abuse.\n* Pregnant, breastfeeding, or lactating women. Women of child-bearing potential (i.e. not surgically sterilized or post- menopausal) must have a negative blood serum pregnancy test performed at the screening visit and must agree to use two methods of birth control (one of which must be a barrier method) for at least 3 months past the last day on the study.\n* Participation in an interventional clinical study within 3 months of study Day 1 or receipt of any investigational medicinal product within 3 months or 5 half- lives.\n* Lung volume reduction surgery or bronchoscopic lung volume reduction within the last 12 months.\n* Historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease\u002Fcondition exacerbated during the study.\n* Other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis, or Eosinophilic Esophagitis.\n* Cirrhosis or current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen \\[HbsAg\\] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.\n* Active blood born infection (e.g. HIV, Hepatitis A, B or C)\n* Current or recent (\\\u003C2 weeks) treatment with oral steroids, theophylline, chronic azithromycin or other methylxanthines, roflumilast, or Dupixent\n* Current infection or antibiotic treatment\n* Use of probiotics within 2 weeks of study Day 1\n* Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD)\n* Subjects receiving treatment with oxygen more than 4.0 Litres\u002Fminute (L\u002Fmin). While breathing supplemental oxygen, subjects should demonstrate oxyhemoglobin saturation greater than or equal to 89 percent.","40 Years","82 Years",{"count":102,"type":22},27,[25],"The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)",[106,107,108],"COPD (Chronic Obstructive Pulmonary Disease)","COPD Exacerbation","COPD Exacerbation Acute",[110],"COPD","2026-01-27",{"date":113,"type":34},"2026-01-29",{"date":88,"type":22},{"date":90,"type":22},{"name":40,"class":41},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":136,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100546705","phase-1-r-5780-01-in-combination-with-pd-1-checkpoint-inhibitors-checkpoint-protein-on-immune-cells-called-t-cells-in-patients-with-solid-tumors-100546705","NCT06398418","R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors","A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years of age to 80\n* Ability to provide written informed consent\n* Unresectable stage III or stage IV melanoma, basal cell carcinoma, or squamous cell carcinoma as per the American Joint Committee on Cancer 2017 Guidelines (8th Edition) regardless of BRAF mutation status and other solid tumors.\n* Refractory to anti-PD (checkpoint Protein on Immune Cells called T cells)-1\u002FL1 therapy per RECIST v1.1 defined as subject who has disease progression after receiving at least two complete cycles of ICI (immune checkpoint inhibitors) therapy or disease progression 6 months from initiation of ICI (immune checkpoint inhibitors) therapy while still on active therapy.\n* Life expectancy of greater than 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Subjects must have evaluable disease by CT (computer tomography) or MRI (magnet resonance imaging) per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response.\n\nExclusion Criteria:\n\n* Any serious medical condition or laboratory abnormality or psychiatric condition or any other significant or unstable concurrent medical illness (in the opinion of the Investigator) would preclude protocol adherence or would make the safety of the study drug difficult to assess\n* Treatment with systemic broad-spectrum antibiotics.\n* No active viral infections.\n* Coexisting severe chronic diseases other than cancer (autoimmunity, inflammatory diseases)\n* Secondary gastrointestinal motility disorders\n* History of solid organ transplant or bone marrow transplant\n* Prior CAR-T (chimeric antigen receptor) or allogeneic cellular therapy\n* Ongoing systemic immunosuppressive therapy, with the exclusion of prednisone (10 mg\u002Fday)\n* Concurrent therapy with any other investigational agent, vaccine, or device\n* Pregnant or breastfeeding or planning to conceive or father a child during the trial period\n* Subjects with untreated brain metastasis. Treated brain metastasis are permitted if stable\n* More than 4 prior systemic therapies\n* Other cancer medications during treatment period are not permitted\n* Enrollment in other clinical trials.","80 Years",{"count":126,"type":22},33,[25],"The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor (checkpoint protein on immune cells called T cells) with Solid Tumors.",[130,131,132,133,134,135],"Solid Tumor, Adult","Solid Tumor","Melanoma","Basal Cell Cancer","Squamous Cell Cancer","Adenoma",[137],"Solid Tumors","2025-08-27",{"date":140,"type":34},"2025-09-04",{"date":142,"type":34},"2025-08-01",{"date":144,"type":22},"2027-12-31",{"name":40,"class":41},1,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100538928","phase-1-r-2487-in-patients-with-sjogrens-syndrome-ss-100538928","NCT06297213","R-2487 in Patients With Sjogren's Syndrome (SS)","A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SS)","R-2487-SS-01","Inclusion Criteria:\n\n* Diagnosis of SS according to American-European Consensus Group Criteria\n* Able to provide informed consent\n* Subjects receiving prednisone (10 mg or less\u002Fday) must be on a stable dose for more than 2 weeks\n* All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.\n* The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.\n\nExclusion Criteria:\n\n* No known active overlapping or associated other autoimmune disease\n* Prior allogenic or autologous bone marrow or organ transplantation\n* Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism\n* Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n* Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months\n* Subjects with evidence of active or latent tuberculosis\n* Active infection of the salivary or lacrimal glands\n* Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP\n* Pregnant or breastfeeding women\n* Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:\n\nHemoglobin level \\\u003C 9.0 g\u002FdL\n\nAbsolute white blood cell (WBC) count of \\\u003C3.0×109\u002FL (\\\u003C3000\u002Fmm3), or absolute neutrophil count of \\\u003C1.2×109\u002FL (\\\u003C1200\u002Fmm3), or absolute lymphocyte count of \\\u003C0.8×109\u002FL (\\\u003C800\u002Fmm3).\n\nThrombocytopenia, defined by platelet count \\\u003C100×109\u002FL (\\\u003C100,000\u002Fmm3)\n\nChronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2, based on the age appropriate calculation.\n\nProteinuria ≥3+.\n\nTotal bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN).\n\nPreviously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (\\> F3)\n\n* Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.\n* Subjects should not receive any of the following medications:\n\nRituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1\n\n* Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).",{"count":51,"type":22},[25],"The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.\n\nPatients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.",[159,160,161],"Sjogren's Syndrome","Sjögren","Sjögren Syndrome, Unspecified",[159],{"date":140,"type":34},{"date":165,"type":22},"2026-06-01",{"date":167,"type":22},"2028-08-30",{"name":40,"class":41},""]