Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease

Обзор

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.

Вмешательства

• Препарат Telitacicept
  Subjects will receive Telitacicept.
• Препарат Placebo
  The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.

Первичные конечные точки

• Change from Baseline in FVC(mL) at Week 52 [Срок оценки: Baseline and Week 52]

Вторичные конечные точки (12)

• Change from Baseline in FVC%Pred at Week 52 [Срок оценки: Baseline and Week 52]
• Change from Baseline in DLCO%Pred at Week 52 [Срок оценки: Baseline and Week 52]
• Time to ILD Progression or Death [Срок оценки: The time from Baseline to Week 52]
• Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52 [Срок оценки: Baseline and Week 52]
• Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52 [Срок оценки: Baseline and Week 52]
• the proportion of subjects with a QILD-WL score reduction ≥2% at week 52 [Срок оценки: Baseline and Week 52]
• The proportion of subjects who showed a ≥5% decrease in FVC (mL) from baseline at week 52; [Срок оценки: Baseline and Week 52]
• The proportion of subjects who showed a ≥10% decrease in FVC (mL) from baseline at week 52; [Срок оценки: Baseline and Week 52]
• Change from Baseline in the short form health survey（SF-36） at Week 52 [Срок оценки: Baseline and Week 52]
• Change from Baseline in Patient global impression of severity（PGI-S） at Week 52 [Срок оценки: Baseline and Week 52]
• Changes from baseline in immunological markers（IgG、IgA、IgM、CD19+ B）at Week 52 [Срок оценки: Baseline and Week 52]
• Incidence and severity of adverse events [Срок оценки: From signing of informed consent until 4 weeks after the last dose.]

Критерии участия

Критерии включения

• Voluntary informed consent provided;
• Male or female aged ≥ 18 years old;
• Documented diagnosis of rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), idiopathic inflammatory myopathy (IIM), Sjogren's syndrome (SjD) , Systemic sclerosis（SSc）,or mixed connective tissue disease (MCTD) in accordance with internationally recognized classification criteria;
• Diagnosis of ILD on High Resolution Computed Tomography (HRCT) with disease extent of greater than or equal to (≥) 10% of the whole lung (WL-ILD);
• During screening, FVC%Pred ≥ 45%;
• During screening, DLCO%Pred(corrected for hemoglobin) ≥ 30%;
• Stable standard treatment was received before randomization to control ILD and/or connective tissue disease;

Критерии исключения

• 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:

• Previous or planned organ transplantation or bone marrow transplantation;
• Plasma exchange or extracorporeal light separation exchange was performed within 6 months before randomization, or a plasma filtration device was used;
• Any targeted BLyS or APRIL drug treatment was received within 12 weeks before randomization;
• Biologic therapy was received within 12 weeks or within 5 half-lives of the corresponding drug (whichever is longer) before randomization;
• B-cell depletion drugs were used within 6 months before randomization;
• Non-biological systemic immunosuppressive drugs other than standard treatment were used within 4 weeks before randomization;
• Anti-fibrotic drugs were used within 4 weeks before randomization;
• Cyclophosphamide treatment was received within 6 months before randomization;
• Cytotoxic drugs were used within 6 months before randomization;
• Intravenous or intramuscular glucocorticoids were used within 4 weeks before randomization;
• 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 ;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07495033 · RC18-C309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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