Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-31 @ 3:17 PM
Study NCT ID:
NCT04312594
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2020-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]', 'timeFrame': '24 weeks', 'description': 'Changes in FVC from 24 weeks to baseline'}], 'secondaryOutcomes': [{'measure': 'Progression-free time [ Time Frame: the onset of disease or death from any cause ]', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months', 'description': 'The time from a random date to the onset of disease or death from any cause;'}, {'measure': 'Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];', 'timeFrame': 'from randomization to one month', 'description': 'acute aggravation events should meet all the following conditions: (1) acute exacerbation or aggravation of respiratory distress within 1 month;Chest CT showed new bilateral ground glass shadows or pulmonary interstitial fibrosis with pulmonary consolidation;(3) exclude heart failure, fluid retention and infection caused by acute dyspnea'}, {'measure': 'K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]', 'timeFrame': '24 weeks', 'description': 'absolute value of change from baseline at 24 weeks'}, {'measure': 'mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ]', 'timeFrame': '24 weeks', 'description': 'absolute value of change from baseline at 24 weeks'}, {'measure': 'Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]', 'timeFrame': '6 months, 12 months, 24 months', 'description': 'Survival rate'}, {'measure': 'The severity and incidence of all adverse events and adverse reactions[ Time Frame: within 28 days after the signing of the informed consent]', 'timeFrame': 'within 28 days after the signing of the informed consent', 'description': 'The severity and incidence of all adverse events and adverse reactions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blinded, and placebo-controlled phase II study to evaluate the efficacy and safety of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent signed;at least 50 years of age;no gender limitation.\n2. Diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that AST and ERS and JRS and ALAT publish );\n3. FVC%≥45% normal predicted value;\n4. DLCO≥30% normal predicted value；\n5. FEV1 / FVC ≥0.7\n\nExclusion Criteria:\n\n1. A plan of lung transplant after into group for one year.\n2. In addition of IPF,Other causes cause interstitial lung disease in patients；\n3. Patients with bleeding tendency (INR \\> 2, PT or APTT \\> 1.5 times normal) or cerebral hemorrhage in the past 1 year;\n4. Have used anticoagulant drugs within 1 month（Except for low molecular weight heparin）;\n5. An alcoholic or drug abuser;\n6. Expected survival ≤ one year;\n7. Patients who plan to undergo a operation within study period, such as major operations on chest and abdomen;\n8. Previous use of a JAK inhibitor for more than 10 days or treatment failure;\n9. Suspected allergic to Jaktinib Dihydrochloride Monohydrate , similar drugs (Fedratinib,Ruxolitinib)or their excipients;\n10. Patients with malignant tumors in the previous 5 years;\n11. Patients with other serious diseases that investigators believe may affect patient safety or compliance;\n12. Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (13.9 tendency \\> / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure \\< 160 mmHg, diastolic pressure \\< 100 mmHg), c. peripheral neuropathy (NCI - CTC AE v5.0 standard grade 2 or above)；\n13. Patients hospitalized for deterioration or acute exacerbation of IPF within 1 month prior to screening;\n14. patients who had not fully recovered from surgery within 1 month prior to screening;\n15. Participate in clinical trials of other new drugs or medical devices within 3 months before screening;\n16. Prednisone \\> 15mg/ day or equivalent within 1 month prior to screening;\n17. Those who had used pirfenidone, Nintedanib, azathioprine, cyclophosphamide, cyclosporine A or other immunosuppressive drugs within 1 month prior to screening;\n18. A history of congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism occurred within 6 month prior to screening;\n19. Patients with active TB in the 12 months prior to screening;\n20. Screening patients with arrhythmia requiring treatment, or with QTcB \\>480ms;\n21. At the time of screening, there was evidence of severe impairment of organ function : including ALT and AST \\> 2.5uln;DBIL and TBIL \\> 2.0 ULN;Serum creatinine \\> was 1.5 ULN.\n22. Evidence of active and uncontrolled viral infections such as HIV, HBV (HBsAg positive, hbv-dna positive or ≥10000 copies /ml), HCV (anti-hcv antibody or hcv-rna positive), or bacterial, viral, parasitic or fungal infections requiring treatment with any clinical symptoms;\n23. patients with a history of progressive multifocal leukoencephalopathy in Screening ;\n24. Patients with epilepsy or using antipsychotics(Sleep medicine,for diazepam expect) for treatment of mental illness( schizophrenia,depressed,mania,anxiety,and so on) at the time of screening;\n25. Women who are planning to become pregnant or who are pregnant or breast-feeding and who are unable to use effective contraception throughout the trial period;Male patients who did not use condoms during administration and within 1 month after the last dose;\n26. Subjects who cannot be treated and followed up according to the protocol;\n27. Any subject whom the investigator considers inappropriate for this clinical study.'}, 'identificationModule': {'nctId': 'NCT04312594', 'briefTitle': 'Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'ZGJAK005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jaktinib 50mg BID', 'description': 'Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Jaktinib 75mg BID', 'description': 'Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Jaktinib Hydrochloride Tablets', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'Patients were administered Jaktinib taken orally as tablets twice daily', 'armGroupLabels': ['Jaktinib 50mg BID']}, {'name': 'Jaktinib Hydrochloride Tablets', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'Patients were administered Jaktinib taken orally as tablets twice daily', 'armGroupLabels': ['Jaktinib 75mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients were administered Placebo taken orally as tablets twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jason Wu', 'role': 'STUDY_CHAIR', 'affiliation': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}