- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722964
Study on Intravenous Injection of SHR-1906 in the Treatment of Idiopathic Pulmonary Fibrosis
April 25, 2023 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd
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
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luyao Dong
- Phone Number: 18205132527
- Email: luyao.dong@hengrui.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- China-Japan Friendship Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo,Intravenous injection
|
Experimental: SHR-1906,-Dose A
|
Intravenous injection
|
Experimental: SHR-1906,- Dose B
|
Intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in FVC% (Percent of Predicted FVC value) to week 24
Time Frame: Baseline, Week 24
|
Baseline, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in FVC (L) to Week 4, 8, 12, 16, 20, 24
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, 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
Time Frame: Baseline, Week 12 and Week 24]
|
Baseline, Week 12 and Week 24]
|
Number of Praticipants with an Acute Exacerbation of IPF
Time Frame: Start of Treatment to end of study (approximately 28 weeks)
|
Start of Treatment to end of study (approximately 28 weeks)
|
All-cause mortality
Time Frame: Start of Treatment to end of study (approximately 28 weeks)
|
Start of Treatment to end of study (approximately 28 weeks)
|
Adverse events
Time Frame: Start of Treatment to end of study (approximately 28 weeks)
|
Start of Treatment to end of study (approximately 28 weeks)
|
Serum concentration of SHR-1906
Time Frame: Start of Treatment to end of study (approximately 28 weeks)
|
Start of Treatment to end of study (approximately 28 weeks)
|
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)
|
Start of Treatment to end of study (approximately 28 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2023
Primary Completion (Anticipated)
May 31, 2024
Study Completion (Anticipated)
May 31, 2024
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
February 1, 2023
First Posted (Actual)
February 10, 2023
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1906-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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