[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636838":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":24,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":11,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":48,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants already receiving treatment with mycophenolate","EXPERIMENTAL",null,[13],"Drug: Nerandomilast 18 mg - adult formulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Nerandomilast 18 mg - adult formulation","Participant who are already treated with mycophenolate and have pulmonary fibrosis will receive also treatment with nerandomilast.",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chrisopher Ryerson","Christopher J. Ryerson, Professor, Department of Medicine, University of British Columbia; Director, Interstitial Lung Disease Program, St. Paul's Hospital; Head, Division of Respiratory Medicine, Providence Health Care",[25],{"name":26,"class":27},"Boehringer Ingelheim","INDUSTRY","100636838","phase-4-this-is-a-trial-designed-to-evaluate-the-combination-of-nerandomilast-with-mycophenolate-across-a-wide-variety-of-pulmonary-fibrosis-subtypes-with-the-aim-of-providing-clinicians-with-assurance-that-this-is-an-appropriate-therapeutic-combination-100636838",false,"NCT07570888","This is a Trial Designed to Evaluate the Combination of Nerandomilast With Mycophenolate Across a Wide Variety of Pulmonary Fibrosis Subtypes, With the Aim of Providing Clinicians With Assurance That This is an Appropriate Therapeutic Combination.","Nerandomilast Added to Mycophenolate for Treatment of Pulmonary Fibrosis (NERAM-PF).","NERAM-PF","Inclusion Criteria:\n\n* Any underlying pulmonary fibrosis diagnosis (excluding IPF) with ≥ 10% fibrosis on chest HRCT (performed within 1 year of screening) by volume assessment as determined by the treating physician\n* Anticipated benefit from nerandomilast therapy as determined by the treating physician (note that previous observed progression as defined in previous PPF clinical trials is not required prior to enrolment)\n* Stable dose of mycophenolate for the preceding 3 months, with a minimum total daily dose of 1,500mg for mycophenolate mofetil or 1080mg for mycophenolate sodium\n* Clinically stable for the preceding 6 weeks (did not require addition of corticosteroids for AE-ILD, or any other reason for urgent hospitalization).\n\nExclusion Criteria:\n\n* Diagnosis of IPF\n* Contraindication to treatment with nerandomilast as determined by the treating physician\n* FVC \\\u003C 45% or DLCO \\\u003C 25% based on last PFT (must be performed within 3 months of screening)\n* Use of systemic prednisone \\> 10 mg\u002Fday for \\> 2 weeks within 3 months of screening (initiation of prednisone during the study is permitted if considered clinically indicated in the opinion of the treating physician)\n* Use of azathioprine, cyclophosphamide, rituximab, and\u002For tocilizumab within 3 months of screening (initiation of azathioprine, cyclophosphamide, rituximab, and\u002For tocilizumab during the study is permitted if considered clinically indicated in the opinion of the treating physician)\n* Use of pirfenidone and\u002For nintedanib within 6 weeks of screening (initiation of nintedanib and\u002For pirfenidone during the study is permitted if considered clinically indicated in the opinion of the treating physician)\n* Significant emphysema (\\> 10% volume on HRCT or FEV1\u002FFVC \\\u003C lower limit of normal)\n* Expected survival \\\u003C 6 months as determined by the treating physician","ALL","18 Years",{"count":39,"type":40},120,"ESTIMATED","INTERVENTIONAL",[43],"PHASE4","This is a trial designed to evaluate the combination of nerandomilast with mycophenolate across a wide variety of pulmonary fibrosis subtypes, with the aim of providing clinicians with assurance that this is an appropriate therapeutic combination.",[46,47],"Pulmonary Fibrosis","Interstitial Lung Disease (ILD)",[49,50,51,52,53],"pulmonary fibrosis","interstitial lung disease","nerandomilast","Mycophenolate mofetil","mycophenolate sodium","NOT_YET_RECRUITING","2026-05-05",{"date":57,"type":58},"2026-05-11","ACTUAL",{"date":60,"type":40},"2026-06",{"date":62,"type":40},"2027-07",{"name":5,"class":6}]