Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective T… (NCT07495033) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease
China260 participantsStarted 2026-04-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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✓. 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;
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);