Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary Fibrosis

Last updated: March 20, 2025
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Completed

Phase

2

Condition

Pulmonary Fibrosis

Scar Tissue

Lung Injury

Treatment

Placebo

SHR-1906

Clinical Study ID

NCT05722964
SHR-1906-201
  • Ages 40-80
  • All Genders

Study Summary

To evaluate the efficacy and safety of intravenous SHR-1906 in the treatment of idiopathic pulmonary fibrosis. The study is divided into four stages: screening period, baseline period, treatment period and safe follow-up period. It is planned that 108 patients will be randomly assigned to the following three treatment groups for treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 40 to 80, inclusive, at the time of screening;

  2. IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines (2022) (HRCT diagnosis UIPtype/possible UIP type (standard HRCT confirmed by central review in recent 3months) with or without pathological UIP type/possible UIP type (pathology refers tofrozen lung biopsy or surgical/thoracoscopic lung biopsy);

  3. 90% ≥ FVCpp ≥ 45% during screening period and the first day;

  4. The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30%and ≤ 90%;

  5. Before the screening period, pirfenidone or nidanib with stable dose ≥ 8 weeks (pirfenidone ≥ 1200 mg/denidanib ≥ 200 mg/d) can continue to maintain treatment withstable dose during the study period; Or at least 4 weeks before the screeningperiod, pirfenidone or nidanib was not used (pirfenidone or nidanib was refused dueto intolerance or various factors) ;

Exclusion

Exclusion Criteria:

  1. Evidence of any of the following significant obstructive pulmonary disease: (1) Theratio of forced expiratory volume/forced vital capacity (FEV1/FVC) at the firstsecond is < 0.70 (after using bronchodilator) or (2) HRCT shows that emphysema isgreater than fibrosis;

  2. Interstitial lung diseases (ILD) other than IPF include but are not limited to: anyother type of idiopathic interstitial pneumonia; Lung diseases related to contactwith fibroblasts or other environmental toxins or drugs; Other types of occupationallung diseases; Granulomatous lung disease; Pulmonary vascular disease; Systemicdiseases include vasculitis infectious diseases (i.e. Tuberculosis) and connectivetissue diseases If the diagnosis is unclear, serological examination and/ormultidisciplinary expert group review should be conducted to confirm IPF or othertypes of ILD diagnosis;

  3. A history of other types of respiratory diseases, including respiratory tract, lungparenchyma, pleural cavity, mediastinum, diaphragm or chest wall diseases ordisorders, such as acute respiratory infection, active tuberculosis, etc., whichresearchers believe will affect the primary endpoint of the study or otherwiseaffect the participation of subjects in the study;

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 29, 2023
Estimated Completion Date:
August 07, 2024

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Site Not Available

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