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CompletedNCT04312594Updated Dec 12, 2024

Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

A Phase 2 interventional study of Jaktinib Hydrochloride Tablets and Jaktinib Hydrochloride Tablets in Idiopathic Pulmonary Fibrosis, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Completed at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 91 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent signed;at least 50 years of age;no gender limitation.
  2. Diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that AST and ERS and JRS and ALAT publish );
  3. FVC%≥45% normal predicted value;
  4. DLCO≥30% normal predicted value;
  5. FEV1 / FVC ≥0.7

Exclusion criteria

Exclusion Criteria:

  1. A plan of lung transplant after into group for one year.
  2. In addition of IPF,Other causes cause interstitial lung disease in patients;
  3. Patients with bleeding tendency (INR > 2, PT or APTT > 1.5 times normal) or cerebral hemorrhage in the past 1 year;
  4. Have used anticoagulant drugs within 1 month(Except for low molecular weight heparin);
  5. An alcoholic or drug abuser;
  6. Expected survival ≤ one year;
  7. Patients who plan to undergo a operation within study period, such as major operations on chest and abdomen;
  8. Previous use of a JAK inhibitor for more than 10 days or treatment failure;
  9. Suspected allergic to Jaktinib Dihydrochloride Monohydrate , similar drugs (Fedratinib,Ruxolitinib)or their excipients;
  10. Patients with malignant tumors in the previous 5 years;
  11. Patients with other serious diseases that investigators believe may affect patient safety or compliance;
  12. 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);
  13. Patients hospitalized for deterioration or acute exacerbation of IPF within 1 month prior to screening;
  14. patients who had not fully recovered from surgery within 1 month prior to screening;
  15. Participate in clinical trials of other new drugs or medical devices within 3 months before screening;
  16. Prednisone > 15mg/ day or equivalent within 1 month prior to screening;
  17. Those who had used pirfenidone, Nintedanib, azathioprine, cyclophosphamide, cyclosporine A or other immunosuppressive drugs within 1 month prior to screening;
  18. 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;
  19. Patients with active TB in the 12 months prior to screening;
  20. Screening patients with arrhythmia requiring treatment, or with QTcB >480ms;
  21. 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.
  22. 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;
  23. patients with a history of progressive multifocal leukoencephalopathy in Screening ;
  24. 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;
  25. 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;
  26. Subjects who cannot be treated and followed up according to the protocol;
  27. Any subject whom the investigator considers inappropriate for this clinical study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Jaktinib 50mg BID

    Patients receive the dose of Jaktinib Hydrochloride Tablets orally 50mg twice daily (BID) for 24 weeks.

    Drug: Jaktinib Hydrochloride Tablets

  • Experimental
    Jaktinib 75mg BID

    Patients receive the dose of Jaktinib Hydrochloride Tablets orally 75mg twice daily (BID) for 24 weeks.

    Drug: Jaktinib Hydrochloride Tablets

  • Placebo comparator
    Placebo

    Patients receive the dose of placebo orally twice daily (BID) for 24 weeks.

    Drug: Placebo

Interventions

  • DrugJaktinib Hydrochloride Tablets

    Patients were administered Jaktinib taken orally as tablets twice daily

    Also known as: Jaktinib

  • DrugJaktinib Hydrochloride Tablets

    Patients were administered Jaktinib taken orally as tablets twice daily

    Also known as: Jaktinib

  • DrugPlacebo

    Patients were administered Placebo taken orally as tablets twice daily

06

What researchers measure

Primary outcomes

  1. Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]

    Changes in FVC from 24 weeks to baseline

    Time frame: 24 weeks

Secondary outcomes

  1. 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;

    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

  2. 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

    Time frame: from randomization to one month

  3. K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]

    absolute value of change from baseline at 24 weeks

    Time frame: 24 weeks

  4. mMRC Dyspnea scale:absolute value of change from baseline [ Time Frame: 24 weeks ]

    absolute value of change from baseline at 24 weeks

    Time frame: 24 weeks

  5. Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]

    Survival rate

    Time frame: 6 months, 12 months, 24 months

  6. 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

    Time frame: within 28 days after the signing of the informed consent

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04312594
Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Mar 18, 2020
Start date
Sep 8, 2020
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022
Last update
Dec 12, 2024

Study contacts

Jason Wu
study chair · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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