CTD-ILDPhase 3NCT07495033
Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease
A Phase 3 study testing Telitacicept in people with CTD-ILD, run by RemeGen Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTD-ILD
- What is being tested?
- Telitacicept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 31 May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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 ;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Mengtao Li, 86-10-69154186, Mengtao.li@cstar.org.cn
About this study
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
- Being tested
- Telitacicept, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Subjects will receive Telitacicept.
PlaceboDrug
The placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept | Experimental | Participants will receive elitacicept in addition to standard therapy. Receives: Drug: Telitacicept |
| Placebo | Placebo comparator | Participants will receive placebo in addition to standard therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in FVC(mL) at Week 52
Measured: Baseline and Week 52
Secondary outcomes (12)
Change from Baseline in FVC%Pred at Week 52
Measured: Baseline and Week 52
Change from Baseline in DLCO%Pred at Week 52
Measured: Baseline and Week 52
Time to ILD Progression or Death
Measured: The time from Baseline to Week 52
Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
Measured: Baseline and Week 52
Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
Measured: Baseline and Week 52
the proportion of subjects with a QILD-WL score reduction ≥2% at week 52
Measured: Baseline and Week 52
The proportion of subjects who showed a ≥5% decrease in FVC (mL) from baseline at week 52;
Measured: Baseline and Week 52
The proportion of subjects who showed a ≥10% decrease in FVC (mL) from baseline at week 52;
Measured: Baseline and Week 52
Change from Baseline in the short form health survey（SF-36） at Week 52
Measured: Baseline and Week 52
Change from Baseline in Patient global impression of severity（PGI-S） at Week 52
Measured: Baseline and Week 52
Changes from baseline in immunological markers（IgG、IgA、IgM、CD19+ B）at Week 52
Measured: Baseline and Week 52
Incidence and severity of adverse events
Measured: From signing of informed consent until 4 weeks after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTD-ILDStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495033
- Sponsor's protocol ID
- RC18-C309
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07495033
- Acronym / sponsor ID
- RC18-C309
- Conditions
- CTD-ILD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telitacicept | Experimental | Drug: TelitaciceptParticipants will receive elitacicept in addition to standard therapy. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo in addition to standard therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (34 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelitaciceptSubjects will receive Telitacicept. | Drug | Telitacicept |
| PlaceboThe placebo contains no active ingredients. To maintain the blind, the placebo matches the active drug in all physical aspects. | Drug | Placebo |
Primary outcome
Change from Baseline in FVC(mL) at Week 52
Time frame: Baseline and Week 52
12 secondary outcomes
Change from Baseline in FVC%Pred at Week 52
Time frame: Baseline and Week 52
Change from Baseline in DLCO%Pred at Week 52
Time frame: Baseline and Week 52
Time to ILD Progression or Death
Time frame: The time from Baseline to Week 52
Change from Baseline in Quantitative Interstitial Lung Disease in the Whole Lung (QILD-WL) At Week 52
Time frame: Baseline and Week 52
Change from Baseline in Quantitative Measures of Lung Fibrosis (QLF) in the Whole Lung At Week 52
Time frame: Baseline and Week 52
the proportion of subjects with a QILD-WL score reduction ≥2% at week 52
Time frame: Baseline and Week 52
The proportion of subjects who showed a ≥5% decrease in FVC (mL) from baseline at week 52;
Time frame: Baseline and Week 52
The proportion of subjects who showed a ≥10% decrease in FVC (mL) from baseline at week 52;
Time frame: Baseline and Week 52
Change from Baseline in the short form health survey（SF-36） at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Patient global impression of severity（PGI-S） at Week 52
Time frame: Baseline and Week 52
Changes from baseline in immunological markers（IgG、IgA、IgM、CD19+ B）at Week 52
Time frame: Baseline and Week 52
Incidence and severity of adverse events
Time frame: From signing of informed consent until 4 weeks after the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with CTD-ILD, run by RemeGen Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengtao Li (+86-10-69158354, Mengtao.li@cstar.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in FVC(mL) at Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.