[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"classic-congenital-adrenal-hyperplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:classic-congenital-adrenal-hyperplasia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100570867","phase-2-an-extension-study-to-evaluate-safety-and-efficacy-of-atumelnant-in-participants-with-congenital-adrenal-hyperplasia-100570867",false,"NCT06712823","An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia","An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia (CALM2-CAH)","CALM2-CAH","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n1. Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study.\n\n   1. Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent study and the commencement of the OLE study.\n   2. Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement of the OLE study.\n2. Female participants who engage in heterosexual intercourse must:\n\n   1. Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR\n   2. Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU\u002FL to confirm menopausal status, OR\n   3. Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.\n3. Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile \\[ie, vasectomy with a confirmed absence of sperm in ejaculate\\]; or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug.\n4. Participants are willing and able to give signed informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF).\n5. Participants are willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study.\n2. Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.\n3. Participants have any mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study, and\u002For evidence of poor compliance with medical instructions.\n4. Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator.\n5. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.\n6. Participant is an employee or immediate family member of an employee of Crinetics.\n7. Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an investigational drug in another study.\n8. Participants who have had an active malignant disease within the last 5 years prior to Screening excluding dermal squamous or basal cell carcinoma of the skin with complete local excision or resected cervical carcinoma in situ.\n9. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n\n   Specific for Participants Not Currently Receiving Atumelnant\n10. Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe renal insufficiency (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2 using Chronic Kidney Epidemiology Collaboration \\[CKD-EPI\\] formula) at Screening; or Significant liver disease or alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN), and\u002For total bilirubin \\>1.5×ULN during Screening. Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin \\\u003C3.5 mg\u002FdL (\\\u003C51.3 μmol\u002FL) will be permitted.\n11. Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.\n12. Participants with a history of major surgery\u002Fsurgical therapy for any cause within 4 weeks prior to Screening.\n13. Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol\u002FmL).\n14. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator.\n15. Participant has an average (of 3 electrocardiograms \\[ECGs\\]) Fridericia's corrected QT (QTcF) interval \\>450 milliseconds (msec) (men) or \\>470 msec (women), time interval between P and R waves (PR interval) \\>220 msec, time interval of the QRS complex (QRS) interval \\>120 msec, second- or third-degree atrioventricular block, left bundle branch block, or hemiblock at Screening.","ALL","16 Years","74 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).",[28,29],"Congenital Adrenal Hyperplasia","Classic Congenital Adrenal Hyperplasia",[28,31,32,33],"CAH","CRN04894","atumelnant","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2025-02-25",{"date":42,"type":22},"2029-08",{"name":44,"class":45},"Crinetics Pharmaceuticals Inc.","INDUSTRY",13,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100605232","phase-2-a-study-in-pediatric-participants-with-congenital-adrenal-hyperplasia-balance-cah-100605232","NCT07159841","A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)","A Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension","Inclusion Criteria:\n\nPart A and B participants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female at birth, between 1 to \\\u003C18 years of chronological age at the time of signing the Informed Consent Form (ICF).\n2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency (21-OHD) based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genetic testing, positive newborn screening with confirmatory second tier testing, or cosyntropin stimulation.\n3. Participants must have an elevated morning serum A4 level \\>ULN during Screening obtained prior to morning glucocorticoid (GC) administration.\n4. Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening.\n5. Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period.\n6. Biochemical euthyroidism as determined by the Investigator.\n\nPart C inclusion criteria require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age.\n\nExclusion Criteria:\n\nPart A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. Participants treated with other GCs within 30 days of Screening.\n3. Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone.\n4. Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting.\n5. Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening.\n6. History of cancer excluding cured\u002Ftreated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n7. Abnormal sleep\u002Fwake cycles (as determined by the Investigator).\n8. Female participants who are pregnant or lactating.\n9. Participants who have been dosed with an investigational drug (including atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to the first dose.\n10. Individuals in Part C who do not meet the Part C Inclusion Criteria.","1 Year","17 Years",{"count":57,"type":22},153,[25,59],"PHASE3","The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).",[28,29],[28,31,32,63,64,65],"Atumelnant","Pediatric","Balance-CAH","2026-06-12",{"date":68,"type":38},"2026-06-16",{"date":70,"type":38},"2026-01-22",{"date":72,"type":22},"2030-03",{"name":44,"class":45},35,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100604026","phase-3-a-study-to-evaluate-atumelnant-in-adults-with-congenital-adrenal-hyperplasia-100604026","NCT07144163","A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia","A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)","Inclusion Criteria:\n\n1. Male or female, between ≥18 to \\\u003C75 years of age at the time of signing the ICF.\n2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.\n3. Have classic CAH due to 21-OHD confirmed by the Investigator.\n4. Participants with Visit 2 levels of morning serum A4 as follows:\n\n   * A4 \\>ULN and treated with \\\u003C11 mg\u002Fm2\u002Fday (physiologic) GC doses\n   * OR normal A4 (\\>0.5xULN to ≤1xULN) and treated with ≥14 mg\u002Fm2\u002Fday GC doses\n   * OR A4 \\>ULN and treated with ≥11 mg\u002Fm2\u002Fday GC doses.\n5. On a stable (defined as no dose change of \\>5 mg\u002Fday hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.\n6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.\n7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.\n\nExclusion Criteria:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.\n3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.\n4. Concomitant mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study, and\u002For evidence of poor compliance with medical instructions.\n5. History of cancer excluding cured\u002Ftreated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n6. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.\n7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.\n8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.\n9. Severe erythrocytosis as judged by the Investigator.\n10. Use of atumelnant prior to screening.","18 Years",{"count":84,"type":22},150,[59],"The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.",[28,29],[28,31,32,63,89,90],"Adult","Calm-CAH","2026-06-02",{"date":93,"type":38},"2026-06-04",{"date":95,"type":38},"2025-12-11",{"date":97,"type":22},"2027-05",{"name":44,"class":45},45]