Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 4:17 AM
Study NCT ID:
NCT04987294
Status:
TERMINATED
Last Update Posted:
2023-06-23
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Subjects, Investigators and laboratories involved in the conduct of the study will be blinded to subject treatment assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized 2:1 to receive ALLN-346 or placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Company Financing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': '42 days', 'description': 'Treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Serum Urate', 'timeFrame': '14 Days', 'description': 'Serum urate \\[mg/dL\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia', 'Gout', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 to 70 years\n* Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)\n* Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout\n* Screening eGFR of ≥60 - \\<90 mL/minute/1.73 m2 for Cohort A and ≥30 - \\<60 mL/minute/1.73 m2 for Cohort B.\n* Concomitant medications stable for a minimum of 4 weeks prior to and during Screening\n* Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening\n* Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation\n\nExclusion Criteria:\n\n* Currently taking any oral urate-lowering medication within 2 weeks prior to Screening\n* Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase\n* Gout flare requiring treatment within 14 days prior to or during Screening\n* Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening\n* History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening\n* Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening\n* Prior dosing in ALLN-346 clinical study\n* Per Investigator judgment, is not an ideal clinical study candidate'}, 'identificationModule': {'nctId': 'NCT04987294', 'briefTitle': 'Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allena Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'ALLN-346-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALLN-346 (Engineered Urate Oxidase)', 'description': 'ALLN-346 is novel urate oxidase provided as capsules for oral administration. ALLN-346 will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.', 'interventionNames': ['Drug: ALLN-346']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo capsules for oral administration. Placebo capsules will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALLN-346', 'type': 'DRUG', 'otherNames': ['Engineered urate oxidase'], 'description': 'ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration', 'armGroupLabels': ['ALLN-346 (Engineered Urate Oxidase)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching placebo capsule'], 'description': 'Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Syed Research Consultants, LLC', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Syed Research Consultants, LLC', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Orthopedic Physicians Alaska', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Allameh Medical Corporation', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Eastern Research, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Best Quality Research, Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'New Generation of Medical Research', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33185', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Kendall South Medical Center, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center of Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Elite Clinical Research, LLC', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NY Total Medical Care, PC', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '28655', 'city': 'Morganton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Burke Primary Care', 'geoPoint': {'lat': 35.74541, 'lon': -81.68482}}, {'zip': '44224', 'city': 'Stow', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summit research Group, LLC', 'geoPoint': {'lat': 41.1595, 'lon': -81.44039}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeast Clinical Research Center, LLC', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '75904', 'city': 'Lufkin', 'state': 'Texas', 'country': 'United States', 'facility': 'P&I Clinical Research, LLC', 'geoPoint': {'lat': 31.33824, 'lon': -94.7291}}, {'zip': '78224', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Briggs Clinical Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'C Tosone, MS, RAC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allena Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allena Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}