Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-02-23 @ 2:20 AM
Study NCT ID:
NCT03062618
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-02-16', 'releaseDate': '2022-05-13'}], 'estimatedResultsFirstSubmitDate': '2022-05-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-02-20', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Events (Part A)', 'timeFrame': 'Baseline up to approximately 45 days', 'description': 'Number of participants with a serious adverse event, regardless of causality, by dose and treatment'}, {'measure': 'Number of Participants with One or More Serious Adverse Events (Part B)', 'timeFrame': 'Baseline up to approximately 50 days', 'description': 'Number of participants with a serious adverse event, regardless of causality, by dose and treatment'}, {'measure': 'Number of Participants with One or More Serious Adverse Events (Part C)', 'timeFrame': 'Baseline up to approximately 73 days', 'description': 'Number of participants with a serious adverse event, regardless of causality, by dose and treatment'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A', 'timeFrame': 'Baseline up to 24 hours post-dose on day 2', 'description': 'Mean change from baseline in triplicate 12-lead electrocardiogram (ECG)'}, {'measure': 'Change in Baseline in Triplicate 12-lead ECG in Part B', 'timeFrame': 'Baseline up to 24 hours post-dose on day 6', 'description': 'Mean change from baseline in triplicate 12-lead ECG'}, {'measure': 'Change in Baseline in Triplicate 12-lead ECG in Part C', 'timeFrame': 'Baseline up to approximately day 28', 'description': 'Mean change from baseline in triplicate 12-lead ECG'}, {'measure': 'Change from Baseline in Single 12-Lead ECG in Part A', 'timeFrame': 'Baseline up to approximately 45 days', 'description': 'Mean change from baseline in single 12-lead ECG'}, {'measure': 'Change from Baseline in Single 12-Lead ECG in Part B', 'timeFrame': 'Baseline up to approximately 50 days', 'description': 'Mean change from baseline in single 12-lead ECG'}, {'measure': 'Change from Baseline in Single 12-Lead ECG in Part C', 'timeFrame': 'Baseline up to approximately 73 days', 'description': 'Mean change from baseline in single 12-lead ECG'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs in Part A', 'timeFrame': 'Baseline up to approximately 45 days', 'description': 'Respiration Rate, Heart Rate, Blood Pressure, Temperature'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs in Part B', 'timeFrame': 'Baseline up to approximately 50 days', 'description': 'Respiration Rate, Heart Rate, Blood Pressure, Temperature'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs in Part C', 'timeFrame': 'Baseline up to approximately 73 days', 'description': 'Respiration Rate, Heart Rate, Blood Pressure, Temperature'}, {'measure': 'Number of participants with Physical Examination Findings in Part A', 'timeFrame': 'Baseline up to approximately 45 days', 'description': 'Abnormal physical exam findings'}, {'measure': 'Number of participants with Physical Examination Findings in Part B', 'timeFrame': 'Baseline up to approximately 50 days', 'description': 'Abnormal physical exam findings'}, {'measure': 'Number of participants with Physical Examination Findings in Part C', 'timeFrame': 'Baseline up to approximately 73 days', 'description': 'Abnormal physical exam findings'}, {'measure': 'Number of participants with Laboratory Test Results outside of reference range in Part A', 'timeFrame': 'Baseline up to approximately 45 days', 'description': 'Laboratory results outside of reference range'}, {'measure': 'Number of participants with Laboratory Test Results outside of reference range in Part B', 'timeFrame': 'Baseline up to approximately 50 days', 'description': 'Laboratory results outside of reference range'}, {'measure': 'Number of participants with Laboratory Test Results outside of reference range in Part C', 'timeFrame': 'Baseline up to approximately 73 days', 'description': 'Laboratory results outside of reference range'}, {'measure': 'Maximum Observed Drug Concentration (Cmax) in Part A', 'timeFrame': 'Baseline up to approximately 29 days', 'description': 'Maximum observed plasma concentration of PRCL-02'}, {'measure': 'Maximum Observed Drug Concentration (Cmax) in Part B', 'timeFrame': 'Baseline up to approximately 33 days', 'description': 'Maximum observed plasma concentration of PRCL-02'}, {'measure': 'Maximum Observed Drug Concentration (Cmax) in Part C', 'timeFrame': 'Baseline up to approximately 31 days', 'description': 'Maximum observed plasma concentration of PRCL-02'}, {'measure': 'Time to Maximum Drug Concentration (Tmax) in Part A', 'timeFrame': 'Baseline up to approximately 29 days', 'description': 'Time to maximum plasma concentration of PRCL-02'}, {'measure': 'Time to Maximum Drug Concentration (Tmax) in Part B', 'timeFrame': 'Baseline up to approximately 33 days', 'description': 'Time to maximum plasma concentration of PRCL-02'}, {'measure': 'Time to Maximum Drug Concentration (Tmax) in Part C', 'timeFrame': 'Baseline up to approximately 31 days', 'description': 'Time to maximum plasma concentration of PRCL-02'}, {'measure': 'Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A', 'timeFrame': 'Baseline up to approximately 29 days', 'description': 'Area under the plasma concentration-time curve from time 0 to infinity'}, {'measure': 'Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B', 'timeFrame': 'Baseline up to approximately 33 days', 'description': 'Area under the plasma concentration-time curve during the dosing interval of 24 hours (24h)'}, {'measure': 'Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C', 'timeFrame': 'Baseline up to approximately 31 days', 'description': 'Area under the plasma concentration-time curve during the dosing interval (24h)'}, {'measure': 'Minimum or Trough Concentration (Cmin)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Minimum or trough concentration of PRCL-02'}, {'measure': 'Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Time delay between administration of PRCL-02 and first observed plasma concentration'}, {'measure': 'Elimination Rate (Ke)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Elimination rate of PRCL-02'}, {'measure': 'Terminal Elimination Half-Life (t1/2)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Terminal elimination half-life of PRCL-02'}, {'measure': 'Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Area under the plasma concentration time curve from time zero to 24 hours'}, {'measure': 'Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Area under the plasma concentration time curve from time zero to the last observed time point'}, {'measure': 'Apparent Clearance (CL/F)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Apparent clearance of PRCL-02'}, {'measure': 'Apparent Volume of Distribution (Vd/F)', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Apparent volume of distribution of PRCL-02'}, {'measure': 'Accumulation Ratio', 'timeFrame': 'Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C)', 'description': 'Accumulation ratio of PRCL-02'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParts A and B\n\n* Be 18 to 55 years old\n* Be healthy with absence of clinically significant illness\n* Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after\n* Female participants must be postmenopausal or surgically sterile\n* Have venous access sufficient for blood sampling\n* Be a non-smoker\n\nPart C\n\n* Be 18 to 75 years old\n* Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months\n* Have at least 2 evaluable plaques located in at least 2 body regions\n\nExclusion Criteria:\n\nParts A and B\n\n* Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections\n* Hepatic or renal impairment\n* Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)\n* Female participants who are pregnant or breast feeding\n* Recent or ongoing infection\n* History of alcohol or drug abuse\n* Current or recent enrollment in a clinical trial judged not compatible with this study\n\nPart C\n\n* Have highly active psoriatic arthritis\n* Have pustular, erythrodermic and/or guttate forms of psoriasis\n* Have had a clinically-significant flare of psoriasis during the last 12 weeks\n* Currently or recently taking certain prescribed therapies for psoriasis\n* Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)'}, 'identificationModule': {'nctId': 'NCT03062618', 'briefTitle': 'A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'PRCL Research Inc.'}, 'officialTitle': 'Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)', 'orgStudyIdInfo': {'id': 'PRCL-SMAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Single Dose', 'description': 'Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)', 'interventionNames': ['Drug: PRCL-02']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Single Dose (Placebo)', 'description': 'Two escalating sequences of matching placebo oral tablets, in 3 periods', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Multiple Dose', 'description': 'Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels', 'interventionNames': ['Drug: PRCL-02']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Multiple Dose (Placebo)', 'description': 'Multiple oral doses of placebo for 28 days, at matching dose levels', 'interventionNames': ['Drug: Placebo Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: Multiple Dose', 'description': 'Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels', 'interventionNames': ['Drug: PRCL-02']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part C: Multiple Dose (Placebo)', 'description': 'Multiple oral doses of placebo for 28 days, at matching dose levels', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'PRCL-02', 'type': 'DRUG', 'description': 'Oral tablet(s) administered with water', 'armGroupLabels': ['Part A: Single Dose', 'Part B: Multiple Dose', 'Part C: Multiple Dose']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Administered with water', 'armGroupLabels': ['Part A: Single Dose (Placebo)', 'Part B: Multiple Dose (Placebo)', 'Part C: Multiple Dose (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Chih-ho Hong Medical Inc', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'L3P 1X2', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynde Centre for Dermatology', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'K9J 5K2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKiN Centre for Dermatology', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'K Papp Clinical Research', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'H3Z 2S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Dermatologie et Chirurgie Dermatologique', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1P 0A2', 'city': 'Québec', 'country': 'Canada', 'facility': 'InVentiv Health', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Email PRCL@Choruspharma.com', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PRCL Research Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PRCL Research Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-05-13', 'type': 'RELEASE'}, {'date': '2023-02-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'PRCL Research Inc.'}}}}