Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial to Evaluate the Efficacy and Safety of HRS-9813 in Subjects With Pulmonary Fibrosis

ConditionIPF and PPF
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

To evaluate the efficacy and safety of HRS-9813 in subjects with pulmonary fibrosis。

Eligibility criteria

Qualifiers

Informed consent was obtained to participate in the trial

Patients were aged ≥21 years for PPF and ≥45 years for IPF.

IPF diagnosed within 7 years before screening (including the screening period) or evidence of progressive ILD within 12 months before screening;

HRCT and surgical lung biopsy or transbronchial lung cryobiopsy, when available, support the clinical diagnosis;

Disqualifiers

IPF cohort: i. Interstitial lung disease (ILD) of other known cause; ii. Diagnosis of sarcoidosis or any systemic autoimmune disease;

PPF cohort: IPF diagnosis and UIP features supported by HRCT central reading, surgical lung biopsy, or cryobiopsy pathology.

The presence of emphysema of 50% or more on centrally read HRCT or the degree of emphysema greater than the degree of fibrosis on the basis of the most recent HRCT report.

The presence of clinically significant nonsubstantial lung disease was considered by the investigator to be likely to affect the assessment of the study.

Trial design

Treatments tested in this trial

  • HRS-9813 capsules
  • HRS-9813 capsules
  • HRS-9813 capsule mimetic

Treatment groups

270 Participants
are divided into 3 treatment groups