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Interstitial lung disease (ILD) is a common pulmonary manifestation in chronic tissue diseases (CTD), significantly affecting patient's prognosis.
The main purpose of this study is to evaluate the efficacy of telitacicept compared with placebo in slowing down the decline in lung volume in patients with interstitial lung disease associated with connective tissue disease (CTD-ILD) on the basis of standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept | Experimental | Participants will receive elitacicept in addition to standard therapy. |
|
| Placebo | Placebo Comparator | Participants will receive placebo in addition to standard therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | Subjects will receive Telitacicept. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in FVC(mL) at Week 52 | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in FVC%Pred at Week 52 | Baseline and Week 52 | |
| Change from Baseline in DLCO%Pred at Week 52 | Baseline and Week 52 | |
| Time to ILD Progression or Death |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of Interstitial lung disease other than CTD-ILD;
ILD progresses rapidly within 12 weeks before screening or during screening;
During screening, HRCT showed severe emphysema (the degree of emphysema exceeded that of ILD);
Obstructive pulmonary disease (pre-bronchodilator Forced Expiratory Volume (FEV1) /FVC <0.7);
Pulmonary arterial hypertension requiring therapy, as determined by the investigator;
Having diffuse alveolar hemorrhage (DAH) or other pulmonary conditions that may have confounding effects, as well as related signs or symptoms;
Unable to complete the pulmonary function test, or requiring supplementary oxygen supply;
Clinically significant laboratory abnormalities;
QTc interval prolongation on ECG;
Allergy to human or mouse-derived biological products, or history of other drug allergies, and the investigator deems that the patient is not eligible to participate.
Previous treatments received:
Major surgery within 12 weeks prior to screening or planned during the duration of the study;
Received or plan to receive any live vaccine within 28 days prior to randomization;
Participation in any clinical trial 28 days prior to randomization or within 5 times the half-life of an investigational drug (whichever is longer);
has active hepatitis or a history of severe liver disease;
Acute or chronic infection requiring treatment;
suffered from symptomatic herpes zoster within 12 weeks prior to screening;
Active tuberculosis;
HIV infection;
History of malignant tumors;
Significant cardiovascular disease, liver, kidney, respiratory, endocrine or hematologic disease, or other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study or require hospitalization during the trial;
History of drug or alcohol abuse or dependence;
Pregnant or lactating women, and those intending to become pregnant during the trial;
Patients considered unsuitable by the investigator to participate in the trial ;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengtao Li | Contact | +86-10-69158354 | Mengtao.li@cstar.org.cn | |
| Qian Wang | Contact | +86-10-69158354 | Zhengaqian@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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| Placebo |
| Drug |
The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects. |
|
| The time from Baseline to Week 52 |
| Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52 | Baseline and Week 52 |
| Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52 | Baseline and Week 52 |
| the proportion of subjects with a QILD-WL score reduction ≥2% at week 52 | Baseline and Week 52 |
| The proportion of subjects who showed a ≥5% decrease in FVC (mL) from baseline at week 52; | Baseline and Week 52 |
| The proportion of subjects who showed a ≥10% decrease in FVC (mL) from baseline at week 52; | Baseline and Week 52 |
| Change from Baseline in the short form health survey(SF-36) at Week 52 | Baseline and Week 52 |
| Change from Baseline in Patient global impression of severity(PGI-S) at Week 52 | Baseline and Week 52 |
| Changes from baseline in immunological markers(IgG、IgA、IgM、CD19+ B)at Week 52 | Baseline and Week 52 |
| Incidence and severity of adverse events | From signing of informed consent until 4 weeks after the last dose. |