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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1906
SHR-1906
Placebo
Sponsored by
Guangdong Hengrui Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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); 90% ≥ 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) ; Exclusion Criteria: 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;

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SHR-1906,-Dose A

SHR-1906,- Dose B

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24
Change from Baseline in FVC% (Percent of Predicted FVC value) to 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
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24
Number of Praticipants with an Acute Exacerbation of IPF
All-cause mortality
Adverse events
Serum concentration of SHR-1906
Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline

Full Information

First Posted
January 11, 2023
Last Updated
April 25, 2023
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05722964
Brief Title
Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary Fibrosis
Official Title
Efficacy and Safety of Intravenous Infusion of SHR-1906 in Patients With Idiopathic Pulmonary Fibrosis: a Multicenter, Randomized, Double-blind, Parallel Placebo-controlled Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Comparison of SHR-1906 injection and placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-1906,-Dose A
Arm Type
Experimental
Arm Title
SHR-1906,- Dose B
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1906
Intervention Description
Intravenous injection
Intervention Type
Drug
Intervention Name(s)
SHR-1906
Intervention Description
Intravenous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo,Intravenous injection
Primary Outcome Measure Information:
Title
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24
Time Frame
Baseline, Week 4, 8, 12, 16, 20, 24
Title
Change from Baseline in FVC% (Percent of Predicted FVC value) to Week 4, 8, 12, 16, 20
Time Frame
Baseline, Week 4, 8, 12, 16, 20
Title
Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) to Week 12 and Week 24
Time Frame
Baseline, Week 12 and Week 24
Title
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Scores to Week 12 and Week 24
Time Frame
Baseline, Week 12 and Week 24]
Title
Number of Praticipants with an Acute Exacerbation of IPF
Time Frame
Start of Treatment to end of study (approximately 28 weeks)
Title
All-cause mortality
Time Frame
Start of Treatment to end of study (approximately 28 weeks)
Title
Adverse events
Time Frame
Start of Treatment to end of study (approximately 28 weeks)
Title
Serum concentration of SHR-1906
Time Frame
Start of Treatment to end of study (approximately 28 weeks)
Title
Proportion of anti-SHR-1906 antibody (ADA) formed during the study from baseline
Time Frame
Start of Treatment to end of study (approximately 28 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 90% ≥ 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) ; Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luyao Dong
Phone
18205132527
Email
luyao.dong@hengrui.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaping Dai

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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