Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04209556
Status:
WITHDRAWN
Last Update Posted:
2020-12-17
First Post:
2019-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720458', 'term': 'ropsacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was withdrawn following a strategic portfolio re-prioritization.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants achieving endoscopic response', 'timeFrame': 'At Week 8', 'description': 'Endoscopic response is defined by Mayo endoscopic index \\< 2'}, {'measure': 'Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)', 'timeFrame': 'At Week 60'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'At Week 60', 'description': 'Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \\[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\\], microscopy \\[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \\[urine mucus and leucocytes\\]).'}, {'measure': 'Percentage of participants with clinically significant changes in Electrocardiogram (ECG)', 'timeFrame': 'At Week 60', 'description': 'Clinical significant changes in ECG'}, {'measure': 'Number of Participants With Categorical changes from baseline in Vital Signs Data', 'timeFrame': 'At Week 60', 'description': 'Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 60.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants achieving clinical remission', 'timeFrame': 'At Week 8 and 60', 'description': 'Clinical remission is defined by total Mayo score of ≤ 2 with no individual subscore of \\> 1'}, {'measure': 'Percentage of participants achieving endoscopic remission', 'timeFrame': 'At Week 8 and 60', 'description': 'Endoscopic remission is defined as Mayo endoscopic index of 0'}, {'measure': 'Percentage of participants achieving mucosal healing', 'timeFrame': 'At Week 8 and 60', 'description': 'Mucosal healing is defined as both total Mayo score and histologic index of ≤ 1.'}, {'measure': 'Percentage of participants achieving clinical response', 'timeFrame': 'At Week 8 and 60', 'description': 'Clinical response is defined as a decrease from baseline of at least 3 points in total Mayo score with at least 30% change, accompanied by at least one point decrease or absolute score of 0 or 1 in rectal bleeding subscore.'}, {'measure': 'Mean change from baseline in partial Mayo score over time', 'timeFrame': 'Up to 60 weeks'}, {'measure': 'Change from baseline in total Mayo score', 'timeFrame': 'At Week 8 and 60'}, {'measure': 'Number of Adverse Events (AEs), Serious Adverse Events (SAEs) based on severity and withdrawals due to adverse events (AEs)', 'timeFrame': 'At Week 8'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities', 'timeFrame': 'At Week 8', 'description': 'Following parameters will be analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick \\[urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin\\], microscopy \\[urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous \\[urine mucus and leucocytes\\]).'}, {'measure': 'Percentage of participants with clinically significant changes in Electrocardiogram (ECG)', 'timeFrame': 'At Week 8', 'description': 'Clinically significant changes from baseline in ECG (heart rate, QT, QTc, PR and QRS intervals)'}, {'measure': 'Number of Participants With Categorical Vital Signs Data', 'timeFrame': 'At Week 8', 'description': 'Number of participants with increase from baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 8.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C2501003', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;\n* Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC: Oral, intravascular, or intramuscular corticosteroids; Immunosuppressants (azathioprine \\[AZA\\], 6-MP, or methotrexate \\[MTX\\]); Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg, tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).\n\nExclusion Criteria:\n\n* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or Crohn's disease\n* Participants displaying clinical signs of fulminant colitis or toxic megacolon;\n* Participants with evidence of colonic dysplasia, adenomas or neoplasia."}, 'identificationModule': {'nctId': 'NCT04209556', 'briefTitle': 'A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS', 'orgStudyIdInfo': {'id': 'C2501003'}, 'secondaryIdInfos': [{'id': '2019-003999-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06826647 100 mg once a day (QD)', 'description': 'PF-06826647 100 mg once a day (QD)', 'interventionNames': ['Drug: PF-06826647 100 mg QD']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06826647 300 mg QD', 'description': 'PF-06826647 300 mg QD', 'interventionNames': ['Drug: PF-06826647 300 mg QD']}, {'type': 'EXPERIMENTAL', 'label': 'PF-06826647 600 mg QD', 'description': 'PF-06826647 600 mg QD', 'interventionNames': ['Drug: PF-06826647 600 mg QD']}, {'type': 'EXPERIMENTAL', 'label': 'Open Label Extension, PF-06826647 400 mg QD', 'description': 'PF-06826647 400 mg QD', 'interventionNames': ['Drug: PF-6826647 400 mg QD']}], 'interventions': [{'name': 'PF-06826647 100 mg QD', 'type': 'DRUG', 'description': 'Investigational Product', 'armGroupLabels': ['PF-06826647 100 mg once a day (QD)']}, {'name': 'PF-06826647 300 mg QD', 'type': 'DRUG', 'description': 'Investigational Product', 'armGroupLabels': ['PF-06826647 300 mg QD']}, {'name': 'PF-06826647 600 mg QD', 'type': 'DRUG', 'description': 'Investigational Product', 'armGroupLabels': ['PF-06826647 600 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'PF-6826647 400 mg QD', 'type': 'DRUG', 'description': 'Investigational Product', 'armGroupLabels': ['Open Label Extension, PF-06826647 400 mg QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91303', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'Hope Clinical Research', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'ADVA Clinical Research', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Centinela Valley Endoscopy Center', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Inglewood Imaging Center', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Surinder Saini, M.D., Inc.', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Renaissance Imaging Center (CT/Xray)', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Valley Endoscopy Center (Colonoscopy/Flexible sigmoidoscopy)', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Saludmax Medical Corp.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Alliance Clinical Research of Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gastroenterology Consultants P.C.', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '46410', 'city': 'Merrillville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Internal Medicine Associates (c/o TrialSpark, Inc.)', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'zip': '07013', 'city': 'Clifton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Gastroenterology Associates of New Jersey, LLC (c/o TrialSpark, Inc.)', 'geoPoint': {'lat': 40.85843, 'lon': -74.16376}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Physicians Ambulatory Surgery Center, LLC, dba Physicians Endoscopy Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Digestive Diseases Consultants, P.A.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann SW Surgery Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78230', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Gastroenterology Consultants of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78230', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Victorium Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Radiology Imaging Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Sugar Lakes Family Practice, PA', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterolgy Associates of Northern Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Northern Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Verity Research, Inc.', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22033', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fair Oaks Imaging Center- Reston Radiology Consultants', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '22192', 'city': 'Woodbridge', 'state': 'Virginia', 'country': 'United States', 'facility': 'Associates in Gastroenterology (c/o TrialSpark, inc)', 'geoPoint': {'lat': 38.65817, 'lon': -77.2497}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}