Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 6:29 PM
Study NCT ID:
NCT05804669
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D047748', 'term': 'Pituitary ACTH Hypersecretion'}, {'id': 'D000182', 'term': 'ACTH Syndrome, Ectopic'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with treatment emergent adverse events (TEAEs)', 'timeFrame': 'Up to Day 15'}, {'measure': 'Proportion of participants with adrenal insufficiency', 'timeFrame': 'Up to Day 15'}, {'measure': 'Proportion of participants with safety findings determined by laboratory testing', 'timeFrame': 'Up to Day 15'}, {'measure': 'Assessment of the maximum observed plasma concentration of CRN04894', 'timeFrame': 'Up to Day 15'}, {'measure': 'Assessment of the time to achieve maximum observed plasma concentration of CRN04894', 'timeFrame': 'Up to Day 15'}, {'measure': 'Assessment of the plasma area under the curve of CRN04894', 'timeFrame': 'Up to Day 15'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in early morning serum cortisol', 'timeFrame': 'Up to Day 15'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cushing Syndrome', 'Cushing Disease', 'Ectopic ACTH Syndrome', 'CRN04894', 'atumelnant'], 'conditions': ['Cushing Syndrome', 'Cushing Disease', 'Ectopic ACTH Syndrome']}, 'descriptionModule': {'briefSummary': "A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \\[ACTH\\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \\[EAS\\])", 'detailedDescription': "This is a Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with atumelnant (also known as CRN04894) (an adrenocorticotropic hormone \\[ACTH\\] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \\[EAS\\]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult male or female, aged 18 years or more\n2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome\n3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1\n4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating\n2. History of bilateral adrenalectomy\n3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm\n4. Presence of any known malignancy\n5. Use of mitotane\n6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks"}, 'identificationModule': {'nctId': 'NCT05804669', 'briefTitle': "A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Crinetics Pharmaceuticals Inc.'}, 'officialTitle': "A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)", 'orgStudyIdInfo': {'id': 'CRN04894-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Doses', 'description': 'Sequential, open-label, 10-day or 14-day fixed-dose cohorts.', 'interventionNames': ['Drug: atumelnant']}], 'interventions': [{'name': 'atumelnant', 'type': 'DRUG', 'description': 'Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.', 'armGroupLabels': ['Multiple Ascending Doses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lynnette K Nieman, MD', 'role': 'CONTACT', 'email': 'niemanl@nih.gov', 'phone': '301-496-8935'}, {'name': 'Lynnette K Nieman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Crinetics Clinical Trials', 'role': 'CONTACT', 'email': 'clinicaltrials@crinetics.com', 'phone': '833-827-9741'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crinetics Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}