[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Calibr, a division of Scripps Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100610320","phase-2-clf065-for-chronic-pouchitis-100610320",false,"NCT07226050","CLF065 for Chronic Pouchitis","A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis","OPUS","Inclusion Criteria:\n\n1. Adult subjects aged 18-80 years, inclusive.\n2. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.\n3. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n4. Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:\n\n   ≥ 3 episodes of pouchitis within 1 year of Screening visit, each treated with antibiotic or other prescription therapy for at least 2 weeks OR Requiring maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the Baseline endoscopic visit\n5. The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.\n6. The patient agrees that antibiotic therapy will be managed per investigator discretion in accordance with standard of care.\n7. Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.\n8. A male subject who is nonsterilized and sexually activity with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing informed consent throughout the duration of the study.\n9. Women of childbearing potential must not have a positive pregnancy test at the Screening Visit and must have a negative pregnancy test at the baseline visit prior to study drug dosing. Note: subjects with borderline serum pregnancy test at Screening must have an absence of clinical suspicion of pregnancy or other pathological cause of a borderline result and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.\n10. If female, the patient must be either postmenopausal, OR permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, that is effective from baseline visit through at least 30 days after the last dose of study drug.\n11. Patient is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination\n\nExclusion Criteria:\n\n1. Inability to give informed consent.\n2. The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)\n3. No prior exposure to CLF065\n4. Chronic pouchitis specific:\n\n   1. The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Randomization Visit\n   2. Crohn's disease with disease proximal to the pouch inlet confirmed on prior imaging or endoscopy\n   3. Irritable pouch syndrome\n   4. Predominate or isolated cuffitis\n   5. Mechanical complications of the pouch\n   6. Diverting stoma\n   7. Planned surgical intervention of the pouch\n5. History of malignancy including melanoma (with the exception of localized skin cancers, carcinoma in situ of the cervix and localized prostate cancer) within 2 years of study enrollment\n6. Pregnant or breast feeding.\n7. Lack of effective contraception in women of childbearing potential.\n8. Ongoing treatment with NSAID (nonsteroidal anti-inflammatory drug).\n9. Anastomotic or anal canal stricture which precludes endoscopic evaluation.\n10. The patient has evidence of pelvic sepsis and pelvic penetrating fistulizing disease on clinical exam.\n11. Known diagnosis of primary sclerosing cholangitis.\n12. Fecal transplantation within 12 weeks prior to study enrollment.\n13. History of clinically significant medical conditions or any other reason that in the opinion of the investigator would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.\n14. The patient has any of the following laboratory abnormalities during the Screening Period:\n\n    1. Hemoglobin level \\\u003C8 g\u002FdL\n    2. White blood cell (WBC) count \\\u003C3 x 109\u002FL\n    3. Platelet count \\\u003C100 x 109\u002FL or \\>1200 x 109\u002FL\n    4. Serum creatinine \\>2 x ULN\n    5. Alanine aminotransferase (ALT) or aspartate aminiotransferase (AST) \\>2x ULN\n    6. Alkaline phosphatase \\>2 x ULN","ALL","18 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.",[28],"Pouchitis",[30],"chronic pouchitis","RECRUITING","2026-05-29",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":34,"type":22},{"date":38,"type":22},"2027-06",{"name":40,"class":41},"Calibr, a division of Scripps Research","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100561365","phase-1-study-to-assess-cmr316-in-healthy-volunteers-and-patients-with-idiopathic-pulmonary-fibrosis-100561365","NCT06589219","Study to Assess CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis","A Phase 1\u002F1B Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Nebulized CMR316 in Healthy Volunteers and Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria: Part 1 \\& 2\n\n* Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential, 18-60 years of age.\n* Must agree to use a highly effective method of contraception.\n* Body Mass Index (BMI) 18-33 kg\u002Fm2 as measured at screening.\n* Weight ≤100 kg at screening.\n* Normal lung function, defined as: FVC and FEV1 \\> 80% predicted (based on age, height, race, sex, SaO2 \\> 95% on room air.\n* Heart rate between 50 and 90 beats per minute (BPM).\n* Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination) and screening safety procedures.\n\nInclusion Criteria: Part 3\n\n* Diagnosis of IPF by American Thoracic Society\u002FERS (European Respiratory Society)\u002FJRS (Japanese Respiratory Society)\u002FALAT (Latin America Thoracic Society) 2011 criteria within five years prior to consent.\n* Men or non-pregnant, non-lactating women of non-childbearing potential.\n* Age ≥ 40 years.\n* Mild to moderate IPF as defined by predicted FVC ≥ 55% of normal and predicted DLCO \\> 40% of normal at Screening.\n* Subjects receiving oral pirfenidone or nintedanib for treatment of IPF may participate if they have been on treatment with a stable, well-tolerated dose (as determined by the investigator), for at least 8 weeks prior to consent with no changes to therapy dose and schedule anticipated during the course of study participation.\n* Must be able to understand a written informed consent, which must be obtained prior to any study procedures.\n* Must be willing and able to comply with all study requirements\n\nExclusion Criteria: Part 1 \\& 2\n\n* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.\n* Presence or history of clinically significant hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) or allergy as judged by the investigator. Subjects with a history of seasonal rhinitis (hay fever) or childhood asthma may participate if these conditions are not active or expected to be active during the subject's participation.\n* History of clinically significant cardiovascular, skin, renal, hepatic, respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, illness\u002Finfection\u002Fhospitalization, or surgical procedure within 30 days prior to first dose of study drug. Subjects with a history of pancreatitis, heart failure, acute renal failure, bullous pemphigoid, or severe and disabling arthritis, conditions associated with postmarketing safety reports of oral gliptins, are excluded.\n* Have poor venous access that limits phlebotomy.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin above upper limit of normal (elevated bilirubin in subject's with Gilbert Syndrome is allowed) or other clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody results.\n* Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \\\u003C90 mL\u002Fmin using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Appendix 1: CKD-EPI Equation).\n* Subjects with a corrected QT interval by Fredericia (QTcF) of \\>450 msec at screening or first admission.\n* Positive highly sensitive serum pregnancy test at screening or highly sensitive urine pregnancy test at first admission. Those who are pregnant or lactating will be excluded.\n* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer).\n* Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2.\n* Subjects who have taken, any over-the-counter drug or herbal remedies in the 15 days prior to first IMP administration. Subjects taking prescribed medication in the 90 days prior to first IMP administration. Subjects taking up to 4 g per day of acetaminophen may participate if discontinued at least 15 days prior to first IMP administration. Subjects taking DPP4 inhibitors are prohibited. Subjects taking strong CYP3A inhibitors are prohibited.\n* History of any substance use disorder or alcohol use disorder in the past 2 years, as based on the diagnostic criteria in the Diagnostic and Statistical Manual Fifth Edition (DSM-5).\n* Regular alcohol consumption in men \\>21 units per week and women \\>14 units per week (1 unit = 12 oz 1 bottle\u002Fcan of beer, 1 oz 40% spirit, or 5 oz glass of wine).\n* A confirmed positive alcohol breath test at screening or first admission.\n* Current smokers and those who have a smoking history of ≥ 10 pack-years. A confirmed positive urine cotinine test at screening or first admission.\n* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.\n* Positive test result for common drugs of abuse on screening and first admission.\n* Men with pregnant or lactating partners.\n* Donation of a unit of blood (about 500 mL) within 2 months or donation of plasma within 7 days prior to first dose of study medication.\n* Subjects who are, or are immediate family members of, a study site or Sponsor employee.\n* Active respiratory infection requiring treatment with antibiotics within 4 weeks prior to signing of ICF.\n* Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.\n\nExclusion Criteria: Part 3\n\n* Clinically significant deterioration between screening and Day 1.\n* Use of any investigational drugs within 30 days or 5 half-lives prior to consent, whichever is longer.\n* Serious adverse reaction or serious hypersensitivity to any DPP4 inhibitor (e.g., saxagliptin, sitagliptin) or the formulation excipients.\n* Use of supplemental oxygen for resting hypoxemia.\n* Evidence of significant renal impairment at screening, defined in this protocol as an estimated creatinine clearance (CLcr) of \\\u003C50 mL\u002Fmin using the CKD-EPI equation. Patients with renal insufficiency Clcr ≥ 50 mL\u002Fmin with stable renal function (per clinical discretion, recommend based on average documented clinical chemistry values for at least 6 months) may participate.\n* History of clinically significant and uncontrolled medical illness or clinically significant abnormal clinical chemistry, hematology, or urinalysis that represents a meaningful risk to the subject during this trial, as judged by the Investigator (e.g., heart failure).\n* Subjects with a corrected QT interval by Fredericia (QTcF) of \\>450 msec at screening.\n* Life expectancy \\\u003C one year.\n* Subject listed for lung transplant.\n* Hospitalization or serious illness (as determined by the investigator) within the 3 months prior to consent.\n* Alternative diagnoses that could lead to pulmonary fibrosis such as exposure to drugs, radiation, asbestos.\n* Connective tissue disease that can lead to pulmonary fibrosis such as scleroderma or rheumatoid arthritis.\n* Presence of clinically active, medically diagnosed asthma, chronic obstructive pulmonary disease, or active infection.\n* Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.\n* History of severe hepatic impairment or AST or ALT greater than 3 times the upper limit of normal at screening.\n* The use of required concomitant medications that represents a significant risk to produce an adverse drug interaction with CMR316, assessed by the investigator (in consultation with sponsor and sponsor's medical monitor). Specifically, subjects with Type 1 and Type 2 diabetes are excluded.\n* Smoking within a year prior to consent.",true,"60 Years",{"count":53,"type":22},106,[55],"PHASE1","The purpose of this study is to assess the safety, tolerability and pharmacokinetics single and multiple inhaled doses of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis (IPF).",[58],"Pulmonary Fibroses, Idiopathic",[60,61,62],"Pulmonary","IPF","Inhaled therapy","2025-04-21",{"date":65,"type":35},"2025-04-23",{"date":67,"type":35},"2024-08-19",{"date":69,"type":22},"2026-03",{"name":40,"class":41},1,""]