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Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

A Randomized, Positvel Controlled, Multicenter Study of Effects of Telitacicept vs Cyclophosphamide on Lupus Realted Interstitial Lung Disease

NCT07077486•Tongji Hospital

View on ClinicalTrials.gov

Summary

Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus.

Detailed Description

Pulmonary abnormalities are present in up to 60% of patients with SLE, and up to 10% of the patients will develop clinical interstitial lung disease (ILD). Recent data indicate that Telitacicept is beneficial for lupus nephritis. Our goal is to determine whether Telitacicept is an effective and safe treatment, compared to standard-of-care Cyclophosphamide, for subclinical and clinical ILD in patients with early lupus. The study also explores disease mechanisms in lungs and serum immunological interaction, to identify potential biomarkers for diagnosis, prognosis, and response to treatment of lupus-ILD.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus;
•Male or non-pregnant female aged ≥ 18 years;
•Diagnosis by high-resolution lung CT (HRCT) is clearly consistent with interstitial lung disease (ILD);
•FEV1/FVC%≥60% and diffusion function DLCO (measured value/estimated value) ≥40%;
•Patients voluntarily participate in this trial, have good compliance, and have the ability to understand and sign informed consent before the study.

Exclusion Criteria

•Alanine aminotransferase and/or aspartate aminotransferase (ALT/AST) \> 5 times the upper limit of normal;
•severe chronic kidney disease (stage IV) or need for dialysis (estimated glomerular filtration rate (eGFR) \< 30ml/min/1.73m2);
•Hemoglobin \< 80 g/L;
•WBC \< 2.0×10\^9;
•Platelet \< 50×10\^9;
•Is pregnant or breastfeeding;
•Expected transfer to another hospital in a non-study site within 4 weeks (possibility of loss to follow-up);
•Life expectancy does not exceed 24 weeks;
•Have a history of severe allergies;
•Patients with other serious lung diseases or other clinically significant serious abnormalities in the lungs;
+23 more criteria

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

August 25, 2025

Primary Completion Date

October 25, 2026

Completion Date

March 25, 2027

Last Updated

January 27, 2026

Enrollment

100

ESTIMATED participants

Conditions

Lupus or SLEInterstitial Lung DiseaseSystemic Lupus Erythematosus

Interventions

Methylprednisolone (Corticosteroid)

DRUG

Immunosuppressant other than CYC

DRUG

Telitacicept Freeze-dried powder Injection 80mg

DRUG

Cyclophosphamide (CYC)

DRUG

Contacts

YIKAI Dr. YU, M.D

CONTACT

+86-15671678920 yuyikai@163.com

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effects of Telitacicept vs Cyclophosphamide on Lupus Related Interstitial Lung Disease

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

Alnuctamab for Refractory SLE (LATTE Study)

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132