Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-27 @ 12:43 AM
Study NCT ID:
NCT06362759
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effects of TOUR006 compared with placebo on hs-CRP', 'timeFrame': '90 days', 'description': 'Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effects of TOUR006 compared with placebo on hs-CRP', 'timeFrame': '90 days', 'description': 'Percent of participants achieving hs-CRP less than 2 mg/L'}, {'measure': 'Evaluate the effects of TOUR006 compared with placebo on hs-CRP', 'timeFrame': '180 days', 'description': 'Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo'}, {'measure': 'Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006', 'timeFrame': 'Baseline through Day 365', 'description': 'Evaluates the serum concentrations of TOUR006 over time'}, {'measure': 'Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD', 'timeFrame': '365 days', 'description': 'Evaluates the percentage of participants with treatment emergent adverse events and serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interleukin-6', 'IL-6', 'IL6', 'Interleukin-6 Inhibitors', 'Anti-interleukin-6 Agents', 'Anti-inflammatory Agents', 'Antiinflammatory Agent', 'Antiinflammatory Agents', 'Agents, Antiinflammatory', 'Anti-inflammatory Agent'], 'conditions': ['Chronic Kidney Diseases', 'Chronic Kidney Insufficiency', 'Chronic Renal Diseases', 'Chronic Renal Insufficiency', 'Kidney Insufficiency, Chronic', 'C-Reactive Protein', 'High Sensitivity C-Reactive Protein', 'Hs-CRP', 'hsCRP']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 (also known as pacibekitug) in participants with chronic kidney disease and elevated hs-CRP.', 'detailedDescription': 'Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease (ASCVD) and heart failure. This Phase 2 study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006, a fully human monoclonal antibody against IL-6. TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling, thereby reducing the pharmacodynamic marker, hs-CRP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years at time of ICF signature.\n* Serum hs-CRP level ≥2.0 mg/L and \\<15 mg/L\n* Diagnosis of chronic kidney disease, eGFR ≥15 and \\<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR\\>200 mg/g\n* Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.\n* Agreement to comply with contraception and reproduction restrictions\n\nExclusion Criteria:\n\n* Clinical evidence or suspicion of active infection\n* Current or recent COVID-19 infection within 30 days\n* Serious infection within 6 months or more than 1 such episode within 18 months\n* Any history of a serious opportunistic infection within 18 months\n* Known history of immunodeficiency\n* History of gastrointestinal ulceration or perforation within 12 months\n* History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months\n* History of GI bleeding requiring hospitalization and/or transfusion within 6 months\n* New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months\n* Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months'}, 'identificationModule': {'nctId': 'NCT06362759', 'acronym': 'TRANQUILITY', 'briefTitle': 'A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tourmaline Bio, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein', 'orgStudyIdInfo': {'id': 'TOUR006-C01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOUR006 - 50 MG', 'description': '50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)', 'interventionNames': ['Drug: TOUR006 - 50 MG']}, {'type': 'EXPERIMENTAL', 'label': 'TOUR006 - 25 MG', 'description': '25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)', 'interventionNames': ['Drug: TOUR006 - 25 MG']}, {'type': 'EXPERIMENTAL', 'label': 'TOUR006 - 15 MG', 'description': '15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150', 'interventionNames': ['Drug: TOUR006 - 15 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'TOUR006 - 50 MG', 'type': 'DRUG', 'description': 'TOUR006 50 MG', 'armGroupLabels': ['TOUR006 - 50 MG']}, {'name': 'TOUR006 - 25 MG', 'type': 'DRUG', 'description': 'TOUR006 25 MG', 'armGroupLabels': ['TOUR006 - 25 MG']}, {'name': 'TOUR006 - 15 MG', 'type': 'DRUG', 'description': 'TOUR006 15 MG', 'armGroupLabels': ['TOUR006 - 15 MG']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site - 0101', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35763', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site - 0135', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Site - 0145', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site - 0104', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91773', 'city': 'San Dimas', 'state': 'California', 'country': 'United States', 'facility': 'Site - 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