Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT03556592
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2018-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574065', 'term': 'tralokinumab'}, {'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of the AUC-last at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates', 'timeFrame': 'Day -7 and Week 15', 'description': 'AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation'}, {'measure': 'Ratio of the Cmax at Week 15 (after multiple doses of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates', 'timeFrame': 'Day -7 and Week 15', 'description': 'Cmax = maximum observed plasma concentration'}], 'secondaryOutcomes': [{'measure': 'Ratio of the AUC-last on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates', 'timeFrame': 'Day -7 and Day 8', 'description': 'AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation'}, {'measure': 'Ratio of the Cmax on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates', 'timeFrame': 'Day -7 and Day 8', 'description': 'Cmax = maximum observed plasma concentration'}, {'measure': 'Ratio of the AUC-inf on Day 8 (after a single dose of tralokinumab) to that on Day -7 (at baseline) for each of the 5 substrates', 'timeFrame': 'Day -7 and Day 8', 'description': 'AUC-inf = area under the plasma concentration curve from time 0 to infinity'}, {'measure': 'Number of adverse events', 'timeFrame': 'From Day 1 up to Week 30'}, {'measure': 'Presence of anti-drug antibodies (yes/no)', 'timeFrame': 'From Day 1 up to Week 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:\n\n* 14 weeks of treatment with tralokinumab\n* a single dose of tralokinumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and above.\n* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.\n* History of AD for ≥1 year.\n* Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.\n* AD involvement of ≥10% body surface area at screening and baseline.\n* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.\n* Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:\n\n * ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:\n\n * Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.\n * Cruciferous vegetables (for example broccoli).\n * Chargrilled meat.\n * ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.\n\nExclusion Criteria:\n\n* Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.\n* Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.\n* Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.\n* Consumption of any 1 or more of the following items in the periods specified:\n\n * ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:\n\n * Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.\n * Cruciferous vegetables (for example broccoli).\n * Chargrilled meat.\n * ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.\n* Nausea or diarrhoea 1 week prior to Day -7.\n* Active dermatologic conditions that may confound the diagnosis of AD.\n* Use of tanning beds or phototherapy within 5 weeks prior to Day -7.\n* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 3 weeks prior to Day -7.\n* Treatment with topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors within 1 week prior to Day -7.\n* Receipt of any marketed biological therapy or investigational biologic agent (including immunoglobulin, anti-IgE, or dupilumab):\n\n * Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to Day -7, or until lymphocyte count returns to normal, whichever is longer.\n * Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to Day -7.\n* Active skin infection within 1 week prior to Day -7.\n* Clinically significant infection within 4 weeks prior to Day -7.\n* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.\n* Tuberculosis requiring treatment within 12 months prior to screening.\n* Known primary immunodeficiency disorder.'}, 'identificationModule': {'nctId': 'NCT03556592', 'briefTitle': 'Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'LP0162-1342'}, 'secondaryIdInfos': [{'id': '2018-000534-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All subjects', 'description': 'Tralokinumab - investigational medicinal product:\n\nWeek 0: subcutaneous (SC) injection of tralokinumab loading dose.\n\nWeek 2 to Week 14: SC injection of tralokinumab maintenance dose.\n\nCYP substrates - non-investigational medicinal products:\n\nWeek -1, Week 1, and Week 15: oral administration of caffeine 100 mg, warfarin sodium 5 mg x2, omeprazole 20 mg, metoprolol tartrate 100 mg, and midazolam hydrochloride 2 mg.', 'interventionNames': ['Drug: Tralokinumab', 'Drug: Caffeine', 'Drug: Warfarin', 'Drug: Omeprazole', 'Drug: Metoprolol', 'Drug: Midazolam Hydrochloride']}], 'interventions': [{'name': 'Tralokinumab', 'type': 'DRUG', 'description': 'Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.', 'armGroupLabels': ['All subjects']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': '1x 100 mg tablet', 'armGroupLabels': ['All subjects']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': '2x 5 mg tablets', 'armGroupLabels': ['All subjects']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': '1x 20 mg capsule', 'armGroupLabels': ['All subjects']}, {'name': 'Metoprolol', 'type': 'DRUG', 'description': '1x 100 mg tablet', 'armGroupLabels': ['All subjects']}, {'name': 'Midazolam Hydrochloride', 'type': 'DRUG', 'description': '1 mL of 2 mg/mL oral solution/syrup', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92119', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '2333 ZC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'LEO Pharma Investigational Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Medical expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LEO Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}