Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-29 @ 2:20 AM
Study NCT ID:
NCT03310320
Status:
TERMINATED
Last Update Posted:
2019-04-25
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720454', 'term': 'AZD-0284'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study is double-blind; patients, study site personnel and AZ personnel involved in the evaluation of the data must be kept blinded.\n\nPackaging and labelling of study drug will be performed in a way that ensures blinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b study in patients with moderate to severe plaque psoriasis. The study is designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of AZD0284 compared with placebo as measured by the relative change from baseline in Psoriasis Area and Severity Index score and biomarkers associated with the mechanism of disease and AZD0284. It comprises 8 clinic visits over approximately 10 weeks including screening visit.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'The study is temporarily suspended due to preclinical findings that are currently under evaluation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.', 'timeFrame': '4 weeks', 'description': 'Reduction from baseline to the end of treatment, in gene expression level of IL-17A and CCL20 relative to placebo.'}, {'measure': 'Percent improvement from baseline to the end of treatment in individual Psoriasis Area and Severity Index (PASI) compared to placebo', 'timeFrame': '4 weeks', 'description': 'Change (percent improvement) in Psoriasis Area and Severity Index score(PASI) compared to placebo'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients achieving 75 % reduction from baseline in PASI score, i.e. PASI 75, at week 4', 'timeFrame': '4 weeks', 'description': 'Percent patients acheiving a 75% reduction in PASI score'}, {'measure': 'Proportion of patients achieving 50 % reduction from baseline in PASI score, i.e. PASI 50, at week 4', 'timeFrame': '4 weeks', 'description': 'Percent patients acheiving a 50% reduction in PASI score'}, {'measure': "Reduction in static physician's global assessment (sPGA) score from baseline at week4", 'timeFrame': '4 weeks', 'description': "The change in the Static physician's global assessment (sPGA) score will be assessed"}, {'measure': 'Percent improvement from baseline in involved body surface area (BSA) at week 4', 'timeFrame': '4 weeks', 'description': 'The percent change in the involved body surface area (BSA) will be assessed'}, {'measure': 'Reduction in the pruritus visual analogue scale (pVAS) score from baseline, at week 4', 'timeFrame': '4 weeks', 'description': 'The reduction in the pruritus visual analogue scale (pVAS) score as determined by the patient will be assessed'}, {'measure': 'Cmax : maximum observed plasma concentration', 'timeFrame': '4 weeks', 'description': 'Maximum observed plasma concentration (Cmax) will be assessed'}, {'measure': 'tmax time to reach Cmax', 'timeFrame': '4 weeks', 'description': 'The time to reach the maximum observed plasma concentration (Cmax) will be assessed'}, {'measure': 'Cmin minimum observed plasma concentration', 'timeFrame': '4 weeks', 'description': 'The minimum observed plasma concentration (Cmin) will be assessed'}, {'measure': 'AE(s) and SAE(s)', 'timeFrame': 'Approximately 8 weeks throughout the study', 'description': 'Safety evaluation will include the assessment of adverse and serious adverse events over the course of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plaque psoriasis', 'PASI', 'BSA', 'sPGA', 'P-VAS', 'IL17A-', 'CCL20', 'PK'], 'conditions': ['Plaque Psoriasis Vulgaris']}, 'descriptionModule': {'briefSummary': 'The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. The severity of the disease varies, but in many cases it can have a major impact on their quality of life if not adequately treated.\n\nThe purpose of the study is to determine the short term safety, pharmacodynamic and clinical effect of AZD0284 in patients with psoriasis.', 'detailedDescription': 'This is a randomised, double-blind, placebo-controlled, multi-centre, parallel group Phase 1b study, designed to evaluate the pharmacodynamic effects, clinical efficacy and safety of AZD0284 compared with placebo as measured by the relative change from baseline in Psoriasis Area Severity Index (PASI score), other disease assessments of involved body surface area (BSA), static physicians global assessment score (sPGA), pruritis and biomarkers associated with the mechanism of disease and AZD0284. Disease activity will be assessed throughout the study as will changes in skin biopsy biomarkers. The study population will be comprised of patients with moderate to severe plaque psoriasis as defined by PASI score, BSA and sPGA.\n\nFollowing completion of screening assessments and meeting all eligibility criteria, patients will be randomised to receive AZD0284 or placebo for 4 weeks of treatment followed by a 4 week follow up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed informed consent prior to any study specific procedures.\n* At least 6 months documented history with a diagnosis of moderate to severe plaque psoriasis as defined by the Psoriasis Area and Severity Index (PASI), psoriasis Body Surface Area (BSA) and static Physician Global Assessment (sPGA).\n\nExclusion Criteria:\n\n* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.\n* History and/or presence of tuberculosis, hepatitis, HIV. Other opportunistic infections within 6 months of the study.\n* Clinically significant laboratory abnormalities.\n* Clinically important abnormalities in rhythm, conduction or morphology of the digital Electrocardiogram (ECG) as considered by the Investigator may interfere with the interpretation of study data.\n* Current treatment or treatment for psoriasis with biological therapies within 6 months of study.\n* Efficacy and safety failure of biologic therapies targeting the IL-17 and IL12/23 pathway at any time.\n* Current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of Day 1"}, 'identificationModule': {'nctId': 'NCT03310320', 'acronym': 'DERMIS', 'briefTitle': 'Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Study to Assess Efficacy and Safety of One Dose Level of Oral AZD0284 Given for Four Weeks, Compared to Placebo, in Patients With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'D7800C00003'}, 'secondaryIdInfos': [{'id': '2017-002351-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for AZD0284 oral solution', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AZD0284', 'description': 'AZD0284 oral solution 2.5 mg/mL', 'interventionNames': ['Drug: AZD0284 oral solution 2.5 mg/mL']}], 'interventions': [{'name': 'AZD0284 oral solution 2.5 mg/mL', 'type': 'DRUG', 'otherNames': ['AZD0284'], 'description': 'AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks', 'armGroupLabels': ['AZD0284']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for AZD0284 oral solution, twice daily for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Ioannis Psallidas, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Gothenburg, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}