Health TrialsbyHealthPanel

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis

ConditionIPF
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥40 years, regardless of gender;

Diagnosis of IPF confirmed prior to or during screening per the 2022 ATS/ERS/JRS/ALAT guidelines (Appendix 1);

No treatment with nintedanib or pirfenidone for at least 8 weeks prior to screening (e.g., treatment-naïve or discontinued therapy), with no plans to initiate or resume antifibrotic treatment;

On a stable regimen of nintedanib or pirfenidone for at least 12 weeks prior to screening, without combination therapy with both drugs. [Stable therapy is defined as maintaining a constant dosage with tolerable drug-specific adverse events];

Disqualifiers

Clinically significant airway obstruction during screening [pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7];

Other clinically significant pulmonary abnormalities per investigator judgment (exceptions: conditions requiring no treatment during the trial, e.g., asymptomatic pulmonary nodules, emphysema);

Acute IPF exacerbation within 3 months before screening and/or during screening;

Receiving immunomodulators (excluding oral corticosteroids) for respiratory conditions, or prednisone >15 mg/day (or equivalent);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK44459

    Drug

    HSK44459 Without IPF background therapy

  • HSK44459

    Drug

    HSK44459 With Nintedanib

  • HSK44459

    Drug

    HSK44459 With Pirfenidone

  • Placebo

    Drug

    Placebo Without IPF background therapy

  • Placebo

    Drug

    Placebo With Nintedanib

  • Placebo

    Drug

    Placebo With Pirfenidone

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: HSK44459Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in FVC from baseline at Week 52

Time frame
Week 52

Secondary outcomes

1

Time to first acute IPF exacerbation during the trial

Time frame
Week 52
2

Time to first respiratory-related hospitalization during the trial

Time frame
Week 52
3

Time to >5% relative/absolute decline in FVC% predicted from baseline during the trial

Time frame
Week 52
4

Time to >10% relative/absolute decline in FVC% predicted from baseline during the trial

Time frame
Week 52

Other outcomes

1

Time to first occurrence of any component of the composite endpoint during the trial: first FVC% predicted decline >10% from baseline, acute IPF exacerbation, first respiratory-related hospitalization, or death (whichever occurs first)

Key secondary efficacy endpoint

Time frame
Week 52

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: