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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-9813 capsules

    Drug

    HRS-9813 capsule; High dose

  • HRS-9813 capsules

    Drug

    HRS-9813 capsule; Low dose

  • HRS-9813 capsule mimetic

    Drug

    HRS-9813 capsule mimetic

Treatment groups

270 Participants
are divided into 3 treatment groups
Group A: Treatment group A: HRS-9813 capsulesExperimental treatment 1 intervention
Group B: Treatment group B: HRS-9813 capsulesExperimental treatment 1 intervention
Group C: Treatment group C: HRS-9813 capsule mimetic.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

FVC as a percentage of the predicted value

Time frame
The baseline period lasted until 26weeks after administration

Secondary outcomes

1

The rate of change in ppFVC

Time frame
The baseline period lasted until 26 weeks after administration
2

Absolute change in FVC.

Time frame
The baseline period lasted until 26 weeks after administration
3

Changes in lung carbon monoxide diffusion capacity (DLCO SB) (hemoglobin corrected) and its percentage of the predicted value (ppDLCO SB) (hemoglobin corrected).

Time frame
The baseline period lasted until 26 weeks after administration
4

Proportion of subjects with an absolute decline in ppFVC (%) of ≥10% from baseline.

Time frame
The baseline period lasted until 26 weeks after administration

Other outcomes

Sponsors and contacts

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

Guangdong Hengrui Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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