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

Sponsor
RemeGen Co., Ltd.
Study ID
NCT07495033
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • CTD-ILD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
    Participants will receive elitacicept in addition to standard therapy.
  • Placebo Comparator: Placebo
    Participants will receive placebo in addition to standard therapy.

Primary Outcome Measure

Change from Baseline in FVC(mL) at Week 52 [ Time Frame: Baseline and Week 52 ]

Central Contacts