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

NCT05722964 | Completed Phase 2

• 1 other identifier: SHR-1906-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24

  Baseline, Week 24

Secondary Outcomes (9)

• Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24

  Baseline, Week 4, 8, 12, 16, 20, 24

• Change from Baseline in FVC% (Percent of Predicted FVC value) to Week 4, 8, 12, 16, 20

  Baseline, Week 4, 8, 12, 16, 20

• Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24

  Baseline, Week 12 and Week 24

• Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24

  Baseline, Week 12 and Week 24]

• Number of Praticipants with an Acute Exacerbation of IPF

  Start of Treatment to end of study (approximately 28 weeks)

Study Arms (3)

SHR-1906，-Dose A

EXPERIMENTAL

Drug: SHR-1906

SHR-1906，- Dose B

EXPERIMENTAL

Drug: SHR-1906

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-1906 DRUG

Intravenous injection

SHR-1906，-Dose A

Placebo DRUG

Placebo，Intravenous injection

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 to 80, inclusive, at the time of screening；
• IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines (2022) (HRCT diagnosis UIP type/possible UIP type (standard HRCT confirmed by central review in recent 3 months) with or without pathological UIP type/possible UIP type (pathology refers to frozen lung biopsy or surgical/thoracoscopic lung biopsy)；
• % ≥ FVCpp ≥ 45% during screening period and the first day;
• The percent of predicted DLCO value (corrected by Hb value) at screening is ≥ 30% and ≤ 90%;
• Before the screening period, pirfenidone or nidanib with stable dose ≥ 8 weeks (pirfenidone ≥ 1200 mg/denidanib ≥ 200 mg/d) can continue to maintain treatment with stable dose during the study period; Or at least 4 weeks before the screening period, pirfenidone or nidanib was not used (pirfenidone or nidanib was refused due to intolerance or various factors) ；

You may not qualify if:

• Evidence of any of the following significant obstructive pulmonary disease: (1) The ratio of forced expiratory volume/forced vital capacity (FEV1/FVC) at the first second is \< 0.70 (after using bronchodilator) or (2) HRCT shows that emphysema is greater than fibrosis;
• Interstitial lung diseases (ILD) other than IPF include but are not limited to: any other type of idiopathic interstitial pneumonia; Lung diseases related to contact with fibroblasts or other environmental toxins or drugs; Other types of occupational lung diseases; Granulomatous lung disease; Pulmonary vascular disease; Systemic diseases include vasculitis infectious diseases (i.e. Tuberculosis) and connective tissue diseases If the diagnosis is unclear, serological examination and/or multidisciplinary expert group review should be conducted to confirm IPF or other types of ILD diagnosis;
• A history of other types of respiratory diseases, including respiratory tract, lung parenchyma, pleural cavity, mediastinum, diaphragm or chest wall diseases or disorders, such as acute respiratory infection, active tuberculosis, etc., which researchers believe will affect the primary endpoint of the study or otherwise affect the participation of subjects in the study;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison of SHR-1906 injection and placebo

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 10, 2023
• Study Start: March 29, 2023
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (1)