- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04312594
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
January 28, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This phase 2 study of Jaktinib Dihydrochloride Monohydrate, an oral inhibitor of JAK1 、JAK2 and JAK3, is to assess efficacy and safety in patients with idiopathic pulmonary fibrosis.The study is a randomised,multicentre,double-blind,placebo-controlled,study.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xu Zuo Jun
- Phone Number: 13671345136
- Email: xuzj@hotmail.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Peking Union Medical College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Written informed consent signed;at least 50 years of age;no gender limitation.
- Diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that AST and ERS and JRS and ALAT publish );
- FVC%≥45% normal predicted value;
- DLCO≥30% normal predicted value;
- FEV1 / FVC ≥0.7
Exclusion Criteria:
- A plan of lung transplant after into group for one year.
- In addition of IPF,Other causes cause interstitial lung disease in patients;
- Patients with bleeding tendency (INR > 2, PT or APTT > 1.5 times normal) or cerebral hemorrhage in the past 1 year;
- Have used anticoagulant drugs within 1 month(Except for low molecular weight heparin);
- An alcoholic or drug abuser;
- Expected survival ≤ one year;
- Patients who plan to undergo a operation within study period, such as major operations on chest and abdomen;
- Previous use of a JAK inhibitor for more than 10 days or treatment failure;
- Suspected allergic to Jaktinib Dihydrochloride Monohydrate , similar drugs (Fedratinib,Ruxolitinib)or their excipients;
- Patients with malignant tumors in the previous 5 years;
- Patients with other serious diseases that investigators believe may affect patient safety or compliance;
- 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);
- Patients hospitalized for deterioration or acute exacerbation of IPF within 1 month prior to screening;
- patients who had not fully recovered from surgery within 1 month prior to screening;
- Participate in clinical trials of other new drugs or medical devices within 3 months before screening;
- Prednisone > 15mg/ day or equivalent within 1 month prior to screening;
- Those who had used pirfenidone, Nintedanib, azathioprine, cyclophosphamide, cyclosporine A or other immunosuppressive drugs within 1 month prior to screening;
- 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;
- Patients with active TB in the 12 months prior to screening;
- Screening patients with arrhythmia requiring treatment, or with QTcB >480ms;
- 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.
- 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;
- patients with a history of progressive multifocal leukoencephalopathy in Screening ;
- 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;
- 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;
- Subjects who cannot be treated and followed up according to the protocol;
- Any subject whom the investigator considers inappropriate for this clinical study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jaktinib 50mg BID
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.
|
Patients were administered Jaktinib taken orally as tablets twice daily
Other Names:
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Experimental: Jaktinib 75mg BID
Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.
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Patients were administered Jaktinib taken orally as tablets twice daily
Other Names:
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Placebo Comparator: Placebo
Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.
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Patients were administered Placebo taken orally as tablets twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Time Frame: 24 weeks
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Changes in FVC from 24 weeks to baseline
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free time [ Time Frame: the onset of disease or death from any cause ]
Time Frame: 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
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The time from a random date to the onset of disease or death from any cause;
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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
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Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];
Time Frame: from randomization to one month
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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
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from randomization to one month
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K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]
Time Frame: 24 weeks
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absolute value of change from baseline at 24 weeks
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24 weeks
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mMRC Dyspnea scale:absolute value of change from baseline [ Time Frame: 24 weeks ]
Time Frame: 24 weeks
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absolute value of change from baseline at 24 weeks
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24 weeks
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Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]
Time Frame: 6 months, 12 months, 24 months
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Survival rate
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6 months, 12 months, 24 months
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The severity and incidence of all adverse events and adverse reactions[ Time Frame: within 28 days after the signing of the informed consent]
Time Frame: within 28 days after the signing of the informed consent
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The severity and incidence of all adverse events and adverse reactions
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within 28 days after the signing of the informed consent
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2020
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (Actual)
March 18, 2020
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Interstitial
- Fibrosis
- Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- ZGJAK005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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