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

NCT07495033 | Not Yet Recruiting Phase 3

• 1 other identifier: RC18-C309
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CTD-ILD

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in FVC(mL) at Week 52

  Baseline and Week 52

Secondary Outcomes (12)

• 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

  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

Study Arms (2)

Telitacicept

EXPERIMENTAL

Participants will receive elitacicept in addition to standard therapy.

Drug: Telitacicept

Placebo

PLACEBO COMPARATOR

Participants will receive placebo in addition to standard therapy.

Drug: Placebo

Interventions

Telitacicept DRUG

Subjects will receive Telitacicept.

Telitacicept

Placebo DRUG

The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

telitacicept

Central Study Contacts

Mengtao Li

CONTACT

+86-10-69158354; Mengtao.li@cstar.org.cn

Qian Wang

CONTACT

+86-10-69158354; Zhengaqian@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 27, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (1)