Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis

NCT04312594 | Completed Phase 2 DMC

• 1 other identifier: ZGJAK005
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

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

  Changes in FVC from 24 weeks to baseline

  24 weeks

Secondary Outcomes (6)

• Progression-free time [ Time Frame: the onset of disease or death from any cause ]

  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 ];

  from randomization to one month

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

  24 weeks

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

  24 weeks

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

  6 months, 12 months, 24 months

Study Arms (3)

Jaktinib 50mg BID

EXPERIMENTAL

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

Drug: Jaktinib Hydrochloride Tablets

Jaktinib 75mg BID

EXPERIMENTAL

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

Drug: Jaktinib Hydrochloride Tablets

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Jaktinib Hydrochloride Tablets DRUG

Patients were administered Jaktinib taken orally as tablets twice daily

Also known as: Jaktinib

Jaktinib 50mg BID

Placebo DRUG

Patients were administered Placebo taken orally as tablets twice daily

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 18, 2020
• Study Start: September 8, 2020
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)