Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 year.

Diagnosis of PPF other than IPF prior to screening or during the screening period.

Disqualifiers

Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at screening.

In the opinion of the Investigator, other clinically significant pulmonary abnormalities.

Acute ILD exacerbation within 3 months prior to screening and/or during the screening period.

History of malignancy within 5 years prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK44459

    Drug

    HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.

  • Placebo

    Drug

    Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks

Treatment groups

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

Trial outcomes

Primary outcomes

1

The change from baseline in forced vital capacity (FVC) at week 52

FVC is a standard pulmonary function test used to quantify respiratory muscle weakness

Time frame
day 1 and week 52

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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