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

ConditionCTD-ILD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Telitacicept
  • Placebo

Treatment groups

260 Participants
are divided into 2 treatment groups

Sponsors and collaborators