Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 1:29 PM
Study NCT ID:
NCT05669950
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2022-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000312', 'term': 'Adrenal Hyperplasia, Congenital'}], 'ancestors': [{'id': 'D047808', 'term': 'Adrenogenital Syndrome'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D043202', 'term': 'Steroid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 161'}, {'measure': 'Parts A and B: Number of Participants With Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Day 1 up to Day 161'}, {'measure': 'Parts A and B: Cmax: Maximum Observed Serum Concentration of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: Ctrough: Minimum Observed Serum Concentration of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: t½: Apparent Elimination Half-life of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: AUC0-infinity: Area under the plasma concentration curve of x from zero to infinity of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: CL: Apparent Total Serum Clearance of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: Vz: Volume of Distribution During the Terminal Elimination Phase After IV Administration of Lu AG13909', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Parts A and B: Change From Baseline After Each Dose of Lu AG13909 in Blood Concentrations of 17-hydroxyprogesterone (17-OHP) and Androstenedione (A4)', 'timeFrame': 'Baseline up to Day 85'}, {'measure': 'Parts A and B: AUC0-tau: Area under the curve over a dosing interval', 'timeFrame': '0 (predose) up to 24 hours postdose on Day 1 to Day 161'}, {'measure': 'Part C: Morning Concentration of A4 in Blood <Upper Limit of Normal (ULN)', 'timeFrame': 'Day 169'}], 'secondaryOutcomes': [{'measure': 'Part C: Lu AG13909 Serum Concentrations Following Multiple IV Doses', 'timeFrame': 'Baseline up to Day 352'}, {'measure': 'Part C: Change From Baseline of Lu AG13909 in Blood Concentrations of 17-OHP and A4', 'timeFrame': 'Baseline up to Day 169'}, {'measure': 'Part C: Number of Participants With TEAEs', 'timeFrame': 'Baseline up to Day 352'}, {'measure': 'Part C: Number of Participants With ADAs', 'timeFrame': 'Baseline up to Day 352'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Adrenal Hyperplasia']}, 'descriptionModule': {'briefSummary': "This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH. CAH is a rare genetic disorder that affects a person's ability to produce certain hormones. The main goals of this trial are to learn about the safety and tolerability of Lu AG13909, how Lu AG13909 behaves in the body, and how the body responds to Lu AG13909."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParts A and B:\n\n* Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).\n* Morning (pre-glucocorticoid \\[GC\\] replacement dose) blood concentrations of 17-OHP \\>4-times upper limit of normal (ULN).\n* Body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\\^2) (minimum 50 kg) and ≤40 kg/m\\^2.\n* Stable GC replacement therapy for ≥1 month prior to the Screening Visit.\n* For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥3 months prior to the Screening Visit.\n* Apart from CAH, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ECGs, and the results of the safety laboratory tests.\n\nPart C:\n\n* Confirmed diagnosis of 21-hydroxylase deficiency CAH (based on a pathogenic CYP21A2 variant and/or elevated 17-OHP).\n* For Cohort C1 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) \\> ULN for age and sex.\n* For Cohort C2 only: Morning (pre-GC replacement dose) blood concentrations of androgens (A4) ≤ ULN for age and sex and the participant is treated with high doses of GC.\n* Stable GC replacement therapy for ≥1 month prior to the Screening Visit.\n* For the salt-wasting form of CAH, the participant must have been on a stable dose of mineralocorticoid replacement for ≥1 month prior to the Screening Visit.\n\nExclusion Criteria:\n\n* The participant is pregnant or breastfeeding.\n* The participant has a clinically significant abnormal laboratory value, electrocardiogram (ECG) parameter, or vital signs value, or other safety findings at the Screening Visit that indicate a potential risk for the participant if enrolled, in the opinion of the investigator.\n* The participant has a history of known hypersensitivity or intolerance to Lu AG13909 or its excipients.\n\nPart C Only:\n\n* The participant has received at least one dose of Lu AG13909 in Part A or Part B.\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05669950', 'briefTitle': 'A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'A Multi-site, Open-label, Sequential-group, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia', 'orgStudyIdInfo': {'id': '19873A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AG13909', 'description': 'Participants in Part A will receive multiple intravenous (IV) doses of Lu AG13909 per a prespecified dosing schedule. After data from Part A has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part B will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. After data from Part B has shown that a pharmacologically relevant dose level is safe and tolerable, participants in Part C will then receive multiple IV doses of Lu AG13909 per a prespecified dosing schedule. Participants from Part C may be eligible to continue in the optional Treatment Extension.', 'interventionNames': ['Drug: Lu AG13909']}], 'interventions': [{'name': 'Lu AG13909', 'type': 'DRUG', 'description': 'Solution for infusion', 'armGroupLabels': ['Lu AG13909']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'GH Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '413 45', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '17174', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'NIHR/Wellcome Trust Clinical Research Facility', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CB2 0SL', 'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Cambridge Clinical Research Centre', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'SE1 9RT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'NIHR Clinical Research Facility', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1T 7HA', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'University College London Hospital - NIHR', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'CONTACT', 'email': 'LundbeckClinicalTrials@Lundbeck.com', 'phone': '+45 36301311'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}