Idiopathic Pulmonary FibrosisPhase 2NCT04312594
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Idiopathic Pulmonary Fibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Jaktinib Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2020to 9 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Jaktinib Hydrochloride Tablets, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Hydrochloride TabletsDrug
Also called Jaktinib
Patients were administered Jaktinib taken orally as tablets twice daily
Jaktinib Hydrochloride TabletsDrug
Also called Jaktinib
Patients were administered Jaktinib taken orally as tablets twice daily
PlaceboDrug
Patients were administered Placebo taken orally as tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 50mg BID | Experimental | Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks. Receives: Drug: Jaktinib Hydrochloride Tablets |
| Jaktinib 75mg BID | Experimental | Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks. Receives: Drug: Jaktinib Hydrochloride Tablets |
| Placebo | Placebo comparator | Patients receive the dose of placebo orally twice daily (BID) for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Changes in FVC from 24 weeks to baseline
Measured: 24 weeks
Secondary outcomes (6)
Progression-free time [ Time Frame: the onset of disease or death from any cause ]
The time from a random date to the onset of disease or death from any cause;
Measured: 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
Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];
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
Measured: from randomization to one month
K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]
absolute value of change from baseline at 24 weeks
Measured: 24 weeks
mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ]
absolute value of change from baseline at 24 weeks
Measured: 24 weeks
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]
Survival rate
Measured: 6 months, 12 months, 24 months
The severity and incidence of all adverse events and adverse reactions[ Time Frame: within 28 days after the signing of the informed consent]
The severity and incidence of all adverse events and adverse reactions
Measured: within 28 days after the signing of the informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start8 Sep 2020
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312594
- Sponsor's protocol ID
- ZGJAK005
- Status last verified
- Dec 2024
- First submitted
- 27 Feb 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind,Placebo-controlled,Phase 2 Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04312594
- Acronym / sponsor ID
- ZGJAK005
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 50mg BID | Experimental | Drug: Jaktinib Hydrochloride TabletsPatients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks. |
| Jaktinib 75mg BID | Experimental | Drug: Jaktinib Hydrochloride TabletsPatients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive the dose of placebo orally twice daily (BID) for 24 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaktinib Hydrochloride TabletsAlso: JaktinibPatients were administered Jaktinib taken orally as tablets twice daily | Drug | Jaktinib 50mg BID |
| Jaktinib Hydrochloride TabletsAlso: JaktinibPatients were administered Jaktinib taken orally as tablets twice daily | Drug | Jaktinib 75mg BID |
| PlaceboPatients were administered Placebo taken orally as tablets twice daily | Drug | Placebo |
Primary outcome
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Time frame: 24 weeks
Changes in FVC from 24 weeks to baseline
6 secondary outcomes
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
Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];
Time frame: from randomization to one month
K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]
Time frame: 24 weeks
mMRC Dyspnea scale：absolute value of change from baseline [ Time Frame: 24 weeks ]
Time frame: 24 weeks
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]
Time frame: 6 months, 12 months, 24 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Idiopathic Pulmonary Fibrosis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ] (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.