[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lumos Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100588961","phase-3-phase-3-study-of-lum-201-in-children-with-growth-hormone-deficiency-100588961",false,"NCT06948214","Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency","A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Subjects must be naïve to treatment and prepubertal\n* Subjects must have a maximal GH response of \\\u003C 10 ng\u002FmL from 2 prior GH stimulation tests conducted within the preceding 12 months\n* Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex\n* Morning or random cortisol level of ≥ 7.0 μg\u002FdL\n* ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys\n* Baseline height velocity (HV) based on ≥ 6 months of growth assessments \\\u003C 25th percentile for age and sex\n* Bone Age delay of ≥ 12 months compared to the chronological age\n* In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.\n* Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 3 months prior to Day 1\n* Baseline IGF-1 standard deviation score (SDS) ≤ -1.0\n\nExclusion Criteria:\n\n* Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and\u002For limit the response to exogenous growth factor treatment.\n* Arm span to height ratio \\> 2 SDs below the mean for age and sex\n* A medical or genetic condition that, in the opinion of the Investigator and\u002For MM, adds unwarranted risk to use of LUM-201\n* Use of any medication that, in the opinion of the Investigator and\u002For MM, can independently cause short stature or limit the response to exogenous growth factors\n* Current inflammatory diseases requiring systemic corticosteroid treatment for \\> 2 consecutive weeks within the last 3 months prior to the Screening Visit\n* Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency\n* Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM\n* Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit\n* Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments\n* Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \\> upper limit of normal (ULN)\n* Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng\u002FmL on any prior standard of care GH stimulation test completed within 12 months\n* Body weight ≤ 14.0 kg\n* BMI \\\u003C -2 or \\> +2 SDs for age and sex based on WHO standards\n* Birth weight for gestational age \\\u003C 3rd percentile based on WHO standards\n* Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A\u002F4\n* History of spinal, cranial, or total body irradiation\n* Attention deficit hyperactivity disorder (ADHD) diagnosis","ALL","3 Years","11 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.",[27],"Growth Hormone Deficiency (GHD)",[29,30,31,32,33,34,35,36,37,38,39,40,41],"GHD","Pediatric Growth Hormone Deficiency","LUM-201","Growth hormone secretagogue","Height","Catch-up growth","PEM","Oral","Predictive Enrichment Marker","ibutamoren mesylate","OraGrowtH Phase 3 Trial","LUM-201 PEM","GH secretagogue","RECRUITING","2026-07-01",{"date":45,"type":46},"2026-07-02","ACTUAL",{"date":48,"type":46},"2026-05-20",{"date":50,"type":21},"2028-01",{"name":52,"class":53},"Lumos Pharma","INDUSTRY",37,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100602918","phase-3-phase-3-long-term-safety-extension-study-of-lum-201-in-children-with-growth-hormone-deficiency-100602918","NCT07129759","Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency","A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Parent\u002Fcaregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.\n* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.\n* Subject who is sexually active must use an acceptable form of contraception.\n* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.\n\nExclusion Criteria:\n\n* Subject has a medical or genetic condition that, in the opinion of the Investigator and\u002For MMs, adds unwarranted risk to use of LUM-201.\n* Pregnancy.\n* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.","4 Years","12 Years",{"count":20,"type":21},[24],"This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.",[27],"NOT_YET_RECRUITING","2025-08-15",{"date":71,"type":46},"2025-08-19",{"date":73,"type":21},"2026-09",{"date":75,"type":21},"2030-02",{"name":52,"class":53},""]